{"schemaVersion":"2.1","datasetVersion":"2026-07-24.2","generatedAt":"2026-07-24","reviewStatus":"Editorial source review completed; not independently medically reviewed","editorialBoundary":"Educational evidence summaries only. No dosing, sourcing, reconstitution, injection, cycling, stacking, or self-treatment instructions.","citation":"Cite The Peptide Field, the record canonicalPath, dataset version 2026-07-24.2, and every underlying source used for the claim.","reuse":"No additional reuse license is granted by this endpoint. Preserve verdict, scope, evidence basis, review date, and source links together; do not present a record as medical advice or medical review.","changeLogPath":"/corrections#correction-ledger","contactPath":"/corrections","dataset":"peptides","count":20,"records":[{"slug":"semaglutide","name":"Semaglutide","className":"GLP-1 receptor agonist","sequenceLabel":"31 amino acids · modified peptide","tier":"Established","statusLine":"FDA-approved products exist for specific indications","profile":{"humanOutcomes":{"level":"Strong","note":"Large controlled programs support specific approved indications."},"humanPharmacology":{"level":"Strong","note":"Pharmacology and exposure are extensively characterized for approved products."},"safetyKnowledge":{"level":"Strong","note":"Approved labels describe established risks, monitoring, and contraindications."},"productCertainty":{"level":"Strong","note":"High for an authentic approved product; not transferable to every compounded version."}},"oneLine":"A prescription peptide medicine with established uses, product-specific labels, and an important divide between approved and unapproved versions.","reviewedAt":"July 23, 2026","whatItIs":"Semaglutide is the active ingredient in several prescription medicines. Approval, indication, formulation, route, and safety information belong to the specific drug product and its current FDA-approved label.","whatWeKnow":"FDA-reviewed products containing semaglutide have approved indications and official prescribing information. Those labels are the primary source for who a product is for, contraindications, warnings, adverse reactions, and administration.","whatWeDoNotKnow":"Evidence for an approved product cannot automatically be transferred to an unapproved, compounded, counterfeit, or research-labeled product. Similar naming does not establish equivalent quality, safety, or effectiveness.","safetyBoundary":"This guide does not recommend a product, decide eligibility, or provide dosing. Medication decisions belong with a licensed clinician using the current label and the patient’s medical history.","claims":[{"claim":"“Semaglutide is FDA-approved.”","verdict":"Supported with scope","explanation":"Some drug products containing semaglutide are FDA-approved for specific uses. The product, formulation, and indication matter.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"Specific FDA-approved semaglutide products, formulations, populations, and indications in their current labels.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf"]},{"claim":"“Compounded semaglutide is the same as an approved product.”","verdict":"Misleading","explanation":"FDA says compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness, or quality before marketing.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Compounded or otherwise unapproved semaglutide products compared with FDA-approved products.","sourceUrls":["https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"]},{"claim":"“A result in one population proves the same benefit for everyone.”","verdict":"Not established","explanation":"Trial population, endpoint, formulation, dose, duration, and indication define what a study can support.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"The populations, formulations, endpoints, and durations described in the cited approved-product record.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf"]}],"sources":[{"label":"OZEMPIC (semaglutide) prescribing information, revised 05/2026","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf","kind":"Drug label","year":2026,"accessedAt":"2026-07-23"},{"label":"RYBELSUS (semaglutide) prescribing information, revised 10/2025","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024%2Cs028s029lbl.pdf","kind":"Drug label","year":2025,"accessedAt":"2026-07-23"},{"label":"WEGOVY (semaglutide) prescribing information, revised 03/2026","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf","kind":"Drug label","year":2026,"accessedAt":"2026-07-23"},{"label":"FDA’s concerns with unapproved GLP-1 drugs used for weight loss","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"Drug approvals and databases","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"aliases":["Ozempic","Wegovy","Wegovy HD","Rybelsus","GLP-1 analogue"],"family":"Metabolic peptide medicines","evidenceContext":"Approved human outcomes","productContext":"Ozempic, Wegovy, and Rybelsus are distinct approved products. Evidence, formulation, route, indication, and labeling belong to the exact product.","approvedProducts":["Ozempic","Wegovy","Wegovy HD","Rybelsus"],"productRecords":[{"name":"Ozempic","formulation":"Injection","route":"Subcutaneous","indicationScope":"Adults with type 2 diabetes for labeled glycemic, cardiovascular, and chronic-kidney-disease risk-reduction uses.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf","labelRevision":"May 2026"},{"name":"Rybelsus","formulation":"Tablet","route":"Oral","indicationScope":"Adults with type 2 diabetes for the uses and product strengths defined in the current label; not a weight-management approval.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024%2Cs028s029lbl.pdf","labelRevision":"October 2025"},{"name":"Wegovy","formulation":"Injection and tablet formulations","route":"Subcutaneous or oral, depending on formulation","indicationScope":"Product- and formulation-specific chronic weight management and labeled risk-reduction uses; populations differ by indication.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf","labelRevision":"March 2026"},{"name":"Wegovy HD","formulation":"7.2 mg injection strength","route":"Subcutaneous","indicationScope":"The higher-dose Wegovy injection option for the adult population and weight-management use defined in the current label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf","labelRevision":"March 2026"}],"indications":["Type 2 diabetes for labeled populations","Chronic weight management for labeled populations","Cardiovascular and kidney-risk indications described in current labels"],"reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Expanded product, claim, and source provenance fields."}],"antiDoping":null,"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"},"relatedSlugs":["liraglutide","tirzepatide","retatrutide"]},{"slug":"insulin","name":"Insulin","className":"Peptide hormone · therapeutic protein family","sequenceLabel":"51 amino acids in human insulin · multiple analog products","tier":"Established","statusLine":"Multiple FDA-approved insulin products and biosimilars exist","profile":{"humanOutcomes":{"level":"Strong","note":"Long-term randomized evidence supports monitored insulin strategies for defined diabetes populations."},"humanPharmacology":{"level":"Strong","note":"Product-specific onset, peak, duration, and exposure are extensively characterized."},"safetyKnowledge":{"level":"Strong","note":"Labels and decades of clinical use characterize major risks, especially hypoglycemia."},"productCertainty":{"level":"Strong","note":"High for an authentic approved product; the exact product and formulation still matter."}},"oneLine":"A natural peptide hormone and foundational family of diabetes medicines whose effects, risks, and use depend on the exact product and care plan.","reviewedAt":"July 23, 2026","whatItIs":"Insulin is a hormone made by the pancreas and the name used for a family of biologic medicines. Rapid-acting, short-acting, intermediate-acting, long-acting, and mixed products have different profiles, so the broad word “insulin” is not a complete product description.","whatWeKnow":"Insulin replacement is essential for people with type 1 diabetes and is also used in other forms of diabetes. In the Diabetes Control and Complications Trial, an intensive monitored strategy reduced the development and progression of several long-term complications in people with type 1 diabetes. The same program also documented more severe hypoglycemia, showing why benefit and risk have to be managed together.","whatWeDoNotKnow":"There is no universal insulin product, schedule, target, or intensity that is right for every person. Evidence for one formulation, population, or monitored strategy does not justify free substitution, unsupervised changes, or non-medical use.","safetyBoundary":"Hypoglycemia can be severe and life-threatening. Product mix-ups and unsupervised switches are high-stakes. This guide does not provide dose calculations, correction factors, injection technique, or advice for changing an insulin plan.","claims":[{"claim":"“Insulin is an established treatment for diabetes.”","verdict":"Supported with scope","explanation":"Multiple insulin products are FDA-approved, and long-term human evidence supports insulin strategies in defined diabetes populations. The exact product and care context still matter.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"FDA-approved insulin products and monitored treatment strategies in defined diabetes populations.","sourceUrls":["https://www.fda.gov/consumers/free-publications-women/insulin","https://pubmed.ncbi.nlm.nih.gov/8366922/"]},{"claim":"“All insulin products work the same way and can be swapped freely.”","verdict":"Misleading","explanation":"Insulin products differ in timing, concentration, delivery system, and approved labeling. A switch can require clinical oversight and product-specific instructions.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Product-specific insulin formulations, concentrations, delivery systems, and labels.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020563s214%2C205747s038lbl.pdf","https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes"]},{"claim":"“More intensive insulin treatment is always better.”","verdict":"Misleading","explanation":"The DCCT found important complication reductions alongside substantially more severe hypoglycemia. Treatment intensity must be individualized and monitored.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"The monitored intensive-treatment strategy and type 1 diabetes population studied in the DCCT.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/8366922/","https://pubmed.ncbi.nlm.nih.gov/9000705/"]}],"sources":[{"label":"Insulin: patient and product overview","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/consumers/free-publications-women/insulin","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"HUMALOG (insulin lispro) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020563s214%2C205747s038lbl.pdf","kind":"Drug label","year":2025,"accessedAt":"2026-07-23"},{"label":"The effect of intensive treatment of diabetes on long-term complications in insulin-dependent diabetes mellitus","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/8366922/","kind":"Randomized trial","year":1993,"accessedAt":"2026-07-23"},{"label":"Hypoglycemia in the Diabetes Control and Complications Trial","publisher":"PubMed · Diabetes","url":"https://pubmed.ncbi.nlm.nih.gov/9000705/","kind":"Randomized trial","year":1997,"accessedAt":"2026-07-23"},{"label":"FDA approves the first rapid-acting insulin biosimilar product for diabetes","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"2026 prohibited list","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"aliases":["human insulin","insulin analogue","rapid-acting insulin","basal insulin"],"family":"Metabolic peptide medicines","evidenceContext":"Approved human outcomes","productContext":"Insulin names cover multiple approved biologic products with different concentrations, time-action profiles, delivery systems, and labels.","approvedProducts":["Multiple human insulin and insulin analogue products"],"productRecords":[{"name":"Humalog","formulation":"Multiple product-specific concentrations and delivery presentations","route":"Subcutaneous; intravenous use is product- and setting-specific","indicationScope":"Diabetes treatment in the populations and uses defined by the current Humalog prescribing information; this representative record does not describe every insulin product.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020563s214%2C205747s038lbl.pdf","labelRevision":"2025 label"}],"indications":["Diabetes treatment in product-specific labeled populations"],"reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Expanded product-family, safety, and claim provenance fields."}],"antiDoping":"Insulin is prohibited in sport without an applicable therapeutic-use framework under the WADA hormone and metabolic modulator rules.","antiDopingReview":{"status":"Prohibited","detail":"Insulin is prohibited under the current WADA hormone and metabolic modulator framework unless an applicable therapeutic-use exemption authorizes use.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"relatedSlugs":["semaglutide","liraglutide","tirzepatide"]},{"slug":"tirzepatide","name":"Tirzepatide","className":"GIP and GLP-1 receptor agonist","sequenceLabel":"39 amino acids · modified peptide","tier":"Established","statusLine":"FDA-approved products exist for specific indications","profile":{"humanOutcomes":{"level":"Strong","note":"Large randomized programs support defined glycemic and chronic weight-management outcomes."},"humanPharmacology":{"level":"Strong","note":"Pharmacology and exposure are extensively characterized for approved products."},"safetyKnowledge":{"level":"Strong","note":"Current product labels describe boxed warnings, contraindications, precautions, and adverse reactions."},"productCertainty":{"level":"Strong","note":"High for an authentic approved product; not transferable to every compounded or counterfeit version."}},"oneLine":"A dual GIP and GLP-1 receptor agonist with approved products and large human trials, bounded by product-specific indications, labels, and safety information.","reviewedAt":"July 23, 2026","whatItIs":"Tirzepatide is a modified peptide used as the active ingredient in prescription medicines. Approval belongs to a specific product, indication, formulation, and current label, not to every item marketed with the same ingredient name.","whatWeKnow":"FDA-reviewed labels and large randomized trials support glycemic and weight outcomes in defined populations. SURPASS-2 studied adults with type 2 diabetes, while SURMOUNT-1 studied adults with obesity or overweight and a related complication without diabetes. Those populations, comparators, endpoints, and study durations define the result.","whatWeDoNotKnow":"The evidence does not show that tirzepatide produces the same result for everyone, acts as a universal “metabolic reset,” or establishes longevity or athletic-performance benefits. It also does not make compounded, counterfeit, or research-labeled products equivalent to approved medicines.","safetyBoundary":"Current prescribing information contains a boxed warning and important contraindications, warnings, and precautions. This guide does not decide eligibility, recommend a product, or provide titration or dosing instructions.","claims":[{"claim":"“Tirzepatide has established human outcome evidence for defined metabolic indications.”","verdict":"Supported with scope","explanation":"Approved product labels and large randomized trials support specific glycemic and weight outcomes in defined populations.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Mounjaro and Zepbound in the labeled and trial populations, endpoints, comparators, and durations.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf","https://pubmed.ncbi.nlm.nih.gov/35658024/","https://pubmed.ncbi.nlm.nih.gov/34170647/"]},{"claim":"“Trial results prove tirzepatide works the same way for everyone and should be used indefinitely.”","verdict":"Not established","explanation":"Trials estimate effects for studied populations and durations. They do not establish an identical individual response or a universal treatment duration.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"The defined populations and follow-up durations in SURMOUNT-1 and SURPASS-2.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/35658024/","https://pubmed.ncbi.nlm.nih.gov/34170647/"]},{"claim":"“Compounded tirzepatide is equivalent to an approved product.”","verdict":"Misleading","explanation":"FDA does not review compounded drugs for safety, effectiveness, or quality before marketing, so evidence for an approved product cannot simply be transferred.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Compounded or otherwise unapproved tirzepatide compared with approved Mounjaro or Zepbound.","sourceUrls":["https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"]}],"sources":[{"label":"MOUNJARO (tirzepatide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf","kind":"Drug label","year":2026,"accessedAt":"2026-07-23"},{"label":"ZEPBOUND (tirzepatide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf","kind":"Drug label","year":2026,"accessedAt":"2026-07-23"},{"label":"Tirzepatide once weekly for the treatment of obesity","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/35658024/","kind":"Randomized trial","year":2022,"accessedAt":"2026-07-23"},{"label":"Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/34170647/","kind":"Randomized trial","year":2021,"accessedAt":"2026-07-23"},{"label":"FDA’s concerns with unapproved GLP-1 drugs used for weight loss","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"aliases":["Mounjaro","Zepbound","GIP/GLP-1 agonist"],"family":"Metabolic peptide medicines","evidenceContext":"Approved human outcomes","productContext":"Mounjaro and Zepbound are distinct approved products. Their evidence and labels do not make every compounded or research-labeled tirzepatide product equivalent.","approvedProducts":["Mounjaro","Zepbound"],"productRecords":[{"name":"Mounjaro","formulation":"Injection","route":"Subcutaneous","indicationScope":"Type 2 diabetes uses and populations defined in the current Mounjaro label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf","labelRevision":"2026 label"},{"name":"Zepbound","formulation":"Injection","route":"Subcutaneous","indicationScope":"Chronic weight management and obstructive sleep apnea uses and populations defined in the current Zepbound label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf","labelRevision":"2026 label"}],"indications":["Type 2 diabetes for labeled populations","Chronic weight management for labeled populations","Obstructive sleep apnea indication described in the current Zepbound label"],"reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Expanded product, outcome, and unapproved-version boundaries."}],"antiDoping":null,"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"},"relatedSlugs":["semaglutide","liraglutide","retatrutide"]},{"slug":"bpc-157","name":"BPC-157","className":"Synthetic pentadecapeptide","sequenceLabel":"15 amino acids · investigational","tier":"Emerging","statusLine":"Investigational; no approved formulation","profile":{"humanOutcomes":{"level":"Limited","note":"Small uncontrolled pilots cannot establish a patient benefit."},"humanPharmacology":{"level":"Limited","note":"Human exposure and pharmacokinetic characterization remain sparse."},"safetyKnowledge":{"level":"Limited","note":"The human safety dataset is too small for confident risk estimates."},"productCertainty":{"level":"Unclear","note":"No validated approved formulation; identity and purity vary outside formal research."}},"oneLine":"An investigational peptide with a sizable preclinical literature, early human work, and a large gap between biological signal and proven clinical effect.","reviewedAt":"July 23, 2026","whatItIs":"BPC-157 is a synthetic 15-amino-acid peptide promoted online for injury recovery and other uses. Popularity, testimonials, animal findings, and availability are not evidence of an approved or proven human treatment.","whatWeKnow":"The preclinical literature contains positive signals in cell and animal models, including tendon-healing models. Small human pilot work and registered clinical research now exist, but do not establish a clinical effect in people. FDA's July 2026 PCAC briefing evaluated BPC-157-related bulk substances for a nominated ulcerative-colitis use and documented evidence and safety gaps. That advisory-stage record supports scrutiny; it is not a final FDA determination.","whatWeDoNotKnow":"The available evidence still does not establish that BPC-157 safely heals sports injuries or other conditions in people. Early, uncontrolled, or registered research is not the same as a replicated patient benefit, and a trial listing is not a positive result.","safetyBoundary":"The site will not provide self-injection, reconstitution, dosing, sourcing, or stack instructions. “Research use only” does not establish quality or make a product appropriate for human use.","claims":[{"claim":"“BPC-157 improves tendon healing in preclinical models.”","verdict":"Supported with scope","explanation":"Cell and rat tendon studies report positive healing signals. The scope matters: these results support biological plausibility, not a proven human treatment.","category":"Performance and recovery","evidenceBasis":"Preclinical evidence","scope":"Cell and animal tendon models only; not clinical healing outcomes in people.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/21030672/"]},{"claim":"“BPC-157 heals tendons and muscles in people.”","verdict":"Not established","explanation":"Early human work is too small and limited to establish efficacy. Reliable, replicated human outcome evidence is still needed.","category":"Performance and recovery","evidenceBasis":"No reliable human outcome evidence","scope":"Human tendon and muscle-healing claims; existing pilots and a trial registration do not establish benefit.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/42198317/","https://pubmed.ncbi.nlm.nih.gov/40131143/","https://clinicaltrials.gov/study/NCT07437547"]},{"claim":"“Athletes can use it because it is not a steroid.”","verdict":"Misleading","explanation":"WADA lists BPC-157 under S0 non-approved substances, prohibited at all times for covered athletes.","category":"Performance and recovery","evidenceBasis":"Regulatory or product record","scope":"Athletes subject to the current WADA Code and their applicable governing-body rules.","sourceUrls":["https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list"]}],"sources":[{"label":"July 2026 PCAC briefing on BPC-157-related bulk drug substances","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/193343/download","kind":"FDA review","year":2026,"accessedAt":"2026-07-23"},{"label":"Certain bulk drug substances for use in compounding that may present significant safety risks","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"BPC-157 as an investigational peptide therapeutic: translational development barriers","publisher":"PubMed · Pharmaceutics","url":"https://pubmed.ncbi.nlm.nih.gov/42198317/","kind":"Science review","year":2026,"accessedAt":"2026-07-23"},{"label":"Safety of intravenous infusion of BPC157 in humans: a pilot study","publisher":"PubMed · Alternative Therapies in Health and Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/40131143/","kind":"Human pilot","year":2025,"accessedAt":"2026-07-23"},{"label":"Promoting effect of BPC 157 on tendon healing: tendon outgrowth, cell survival, and migration","publisher":"PubMed · Journal of Applied Physiology","url":"https://pubmed.ncbi.nlm.nih.gov/21030672/","kind":"Preclinical","year":2011,"accessedAt":"2026-07-23"},{"label":"2026 prohibited list","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"},{"label":"BPC 157 for acute hamstring muscle strain repair","publisher":"ClinicalTrials.gov","url":"https://clinicaltrials.gov/study/NCT07437547","kind":"Trial registry","year":2026,"accessedAt":"2026-07-23"}],"aliases":["BPC 157","Body Protection Compound 157","pentadecapeptide BPC 157"],"family":"Recovery and repair claims","evidenceContext":"Investigational human outcomes","productContext":"A peptide sequence, a nominated bulk substance, a clinical-study product, and a consumer vial are separate evidence objects. Identity and product quality cannot be assumed from the name.","approvedProducts":[],"productRecords":[],"indications":["No FDA-approved indication"],"reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Updated around FDA's July 2026 briefing and explicit product-identity boundaries."}],"antiDoping":"BPC-157 is prohibited under WADA's non-approved substances category. Athletes should use the current list and their governing body's rules.","antiDopingReview":{"status":"Prohibited","detail":"BPC-157 is listed under WADA's S0 non-approved substances category and is prohibited at all times for covered athletes.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"relatedSlugs":["tb-500","ghk-cu","ipamorelin"]},{"slug":"cjc-1295","name":"CJC-1295","className":"Long-acting GHRH analogue","sequenceLabel":"Modified peptide · multiple forms discussed","tier":"Emerging","statusLine":"Investigational; no approved product identified","profile":{"humanOutcomes":{"level":"Limited","note":"Human studies measured hormone responses, not durable patient outcomes."},"humanPharmacology":{"level":"Moderate","note":"Randomized studies show sustained GH and IGF-1 biomarker effects in healthy adults."},"safetyKnowledge":{"level":"Limited","note":"Short studies exist, while FDA identifies serious adverse-event and impurity concerns."},"productCertainty":{"level":"Unclear","note":"CJC-1295 with DAC, without DAC, salts, and combinations are often discussed imprecisely."}},"oneLine":"A long-acting growth-hormone-releasing hormone analogue with clear human biomarker activity but no established clinical benefit for popular body-composition or recovery claims.","reviewedAt":"July 23, 2026","whatItIs":"CJC-1295 is a synthetic analogue of growth-hormone-releasing hormone designed to extend biological activity. Online discussions often blur distinct forms, including references to CJC-1295 with or without a drug-affinity-complex modification.","whatWeKnow":"Two randomized, placebo-controlled, double-blind ascending-dose studies in healthy adults found sustained increases in growth hormone and IGF-1 after CJC-1295. A separate human study found increased trough and mean GH secretion with preserved pulsatility. These are real pharmacodynamic findings.","whatWeDoNotKnow":"Biomarker changes do not establish better body composition, injury recovery, sleep, vitality, or longevity. The published human work does not provide a replicated clinical-outcome basis for those popular claims, and long-term safety remains insufficiently characterized.","safetyBoundary":"FDA identifies immunogenicity and peptide-impurity concerns and reports serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction. This guide does not translate research doses into personal use.","claims":[{"claim":"“CJC-1295 can raise GH and IGF-1 in healthy adults.”","verdict":"Supported with scope","explanation":"Randomized human studies reported sustained hormone increases. This supports a biomarker effect, not a patient benefit.","category":"Mechanism and biomarkers","evidenceBasis":"Human pharmacology","scope":"Short-term GH and IGF-1 pharmacodynamic responses in the healthy adults studied.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/16352683/","https://pubmed.ncbi.nlm.nih.gov/17018654/"]},{"claim":"“CJC-1295 builds muscle and burns fat in people.”","verdict":"Not established","explanation":"The identified trials were not designed to establish durable improvements in body composition or function.","category":"Performance and recovery","evidenceBasis":"No reliable human outcome evidence","scope":"Clinical body-composition and functional outcomes, which the cited pharmacology studies did not test.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/16352683/","https://pubmed.ncbi.nlm.nih.gov/17018654/"]},{"claim":"“All products called CJC-1295 are interchangeable.”","verdict":"Misleading","explanation":"The literature and commercial market may refer to different molecular forms, salts, modifications, and combinations.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Products marketed as CJC-1295 with different forms, salts, modifications, combinations, or quality controls.","sourceUrls":["https://www.fda.gov/media/183819/download","https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"]}],"sources":[{"label":"Prolonged GH and IGF-1 stimulation by CJC-1295 in healthy adults","publisher":"PubMed · Journal of Clinical Endocrinology & Metabolism","url":"https://pubmed.ncbi.nlm.nih.gov/16352683/","kind":"Randomized trial","year":2006,"accessedAt":"2026-07-23"},{"label":"Pulsatile GH secretion during continuous stimulation by CJC-1295","publisher":"PubMed · Journal of Clinical Endocrinology & Metabolism","url":"https://pubmed.ncbi.nlm.nih.gov/17018654/","kind":"Human pharmacology","year":2006,"accessedAt":"2026-07-23"},{"label":"Certain bulk drug substances that may present significant safety risks","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"CJC-1295 pharmacy compounding advisory review","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/183819/download","kind":"FDA review","year":2024,"accessedAt":"2026-07-23"},{"label":"2026 prohibited list","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"aliases":["CJC 1295","CJC-1295 DAC","CJC-1295 with DAC"],"family":"Growth signaling","evidenceContext":"Human pharmacology only","productContext":"CJC-1295 with a drug-affinity-complex modification is not interchangeable with products marketed as 'no DAC,' modified GRF 1-29, or unspecified compounded combinations.","approvedProducts":[],"productRecords":[],"indications":["No FDA-approved indication"],"reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Expanded alias, product-identity, and anti-doping context."}],"antiDoping":"Growth-hormone-releasing factors and analogues are prohibited under the current WADA framework.","antiDopingReview":{"status":"Prohibited","detail":"Growth-hormone-releasing factors and analogues are prohibited under the current WADA framework.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"relatedSlugs":["tesamorelin","sermorelin","ipamorelin"]},{"slug":"ipamorelin","name":"Ipamorelin","className":"Ghrelin-receptor agonist · GH secretagogue","sequenceLabel":"Synthetic pentapeptide · investigational","tier":"Emerging","statusLine":"Investigational; no approved product identified","profile":{"humanOutcomes":{"level":"Limited","note":"A phase 2 trial did not show significant benefit on its key efficacy endpoint."},"humanPharmacology":{"level":"Moderate","note":"Dose-escalation work characterizes short-lived GH release in healthy volunteers."},"safetyKnowledge":{"level":"Limited","note":"Route-specific data are sparse and FDA identifies serious safety concerns."},"productCertainty":{"level":"Unclear","note":"No approved formulation anchors identity, purity, or equivalence in the consumer market."}},"oneLine":"A growth-hormone secretagogue with demonstrated human pharmacology, a negative proof-of-concept efficacy trial, and unresolved route, safety, and product-quality questions.","reviewedAt":"July 23, 2026","whatItIs":"Ipamorelin is a synthetic peptide that activates the ghrelin receptor and stimulates growth-hormone release. Human pharmacology studies and a clinical efficacy trial exist, making it a useful example of why biological activity and clinical benefit must be graded separately.","whatWeKnow":"A dose-escalation study in healthy male volunteers characterized ipamorelin exposure and a short episode of GH release. In a multicenter, double-blind, placebo-controlled phase 2 trial after bowel surgery, the drug was described as well tolerated in that setting but did not significantly improve the key or secondary efficacy outcomes.","whatWeDoNotKnow":"Those studies do not establish popular claims about muscle gain, fat loss, recovery, anti-aging, or sleep. They also do not establish the safety or quality of consumer products, compounded combinations, or different routes.","safetyBoundary":"FDA identifies immunogenicity, aggregation, impurity, and characterization concerns. The agency also cites serious adverse events, including death, in intravenous gastric-motility research and says it lacks sufficient information for other promoted injectable routes.","claims":[{"claim":"“Ipamorelin stimulates GH release in people.”","verdict":"Supported with scope","explanation":"A human dose-escalation study measured an episode of GH release. That is a pharmacodynamic effect.","category":"Mechanism and biomarkers","evidenceBasis":"Human pharmacology","scope":"Short-term GH pharmacodynamics in the healthy volunteers and route studied.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/10496658/"]},{"claim":"“A GH response proves better recovery or body composition.”","verdict":"Not established","explanation":"A biomarker response is not a clinical outcome, and the identified studies did not establish those benefits.","category":"Performance and recovery","evidenceBasis":"No reliable human outcome evidence","scope":"Recovery and body-composition outcomes not established by GH pharmacology or the postoperative-ileus trial.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/10496658/","https://pubmed.ncbi.nlm.nih.gov/25331030/"]},{"claim":"“Ipamorelin worked in its phase 2 surgical trial.”","verdict":"Misleading","explanation":"The randomized trial reported no significant difference from placebo on its key and secondary efficacy analyses.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"The postoperative-ileus population, intervention, and efficacy endpoints in the phase 2 trial.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/25331030/"]}],"sources":[{"label":"Pharmacokinetic-pharmacodynamic modeling of ipamorelin in human volunteers","publisher":"PubMed · Pharmaceutical Research","url":"https://pubmed.ncbi.nlm.nih.gov/10496658/","kind":"Human pharmacology","year":1999,"accessedAt":"2026-07-23"},{"label":"Randomized proof-of-concept study of ipamorelin for postoperative ileus","publisher":"PubMed · International Journal of Colorectal Disease","url":"https://pubmed.ncbi.nlm.nih.gov/25331030/","kind":"Randomized trial","year":2015,"accessedAt":"2026-07-23"},{"label":"Certain bulk drug substances that may present significant safety risks","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"2026 prohibited list","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"aliases":["ipamorelin acetate","NNC 26-0161","growth hormone secretagogue"],"family":"Growth signaling","evidenceContext":"Investigational human outcomes","productContext":"Human studies used defined study material and routes. They do not establish the identity, safety, or equivalence of compounded mixtures or consumer-market products.","approvedProducts":[],"productRecords":[],"indications":["No FDA-approved indication"],"reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Expanded trial-outcome, route, and product-quality boundaries."}],"antiDoping":"Growth-hormone secretagogues and mimetics are prohibited under the current WADA framework.","antiDopingReview":{"status":"Prohibited","detail":"Growth-hormone secretagogues and mimetics are prohibited under the current WADA framework.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"relatedSlugs":["cjc-1295","tesamorelin","sermorelin"]},{"slug":"liraglutide","name":"Liraglutide","aliases":["Victoza","Saxenda","GLP-1 analogue"],"className":"GLP-1 receptor agonist","family":"Metabolic peptide medicines","sequenceLabel":"31 amino acids · acylated GLP-1 analogue","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"FDA-approved products exist for specific indications","productContext":"Liraglutide is an active ingredient. Victoza and Saxenda are distinct approved products with different labeled indications and product-specific prescribing information.","approvedProducts":["Victoza","Saxenda"],"productRecords":[{"name":"Victoza","formulation":"Injection","route":"Subcutaneous","indicationScope":"Type 2 diabetes uses and labeled populations defined in the current product prescribing information.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022341Orig1s043lbl.pdf","labelRevision":"November 2024"},{"name":"Saxenda","formulation":"Injection","route":"Subcutaneous","indicationScope":"Chronic weight management in the adult and pediatric populations defined in the current label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s024lbl.pdf","labelRevision":"February 2026"}],"indications":["Type 2 diabetes for labeled populations","Chronic weight management for labeled populations"],"profile":{"humanOutcomes":{"level":"Strong","note":"Large randomized programs support defined glycemic, cardiovascular, and weight-management outcomes."},"humanPharmacology":{"level":"Strong","note":"Approved labels characterize product-specific exposure, pharmacodynamics, and interactions."},"safetyKnowledge":{"level":"Strong","note":"Current labels describe contraindications, warnings, adverse reactions, and monitoring."},"productCertainty":{"level":"Strong","note":"High for authentic approved products; evidence does not transfer automatically to unapproved versions."}},"oneLine":"An established GLP-1 medicine whose evidence belongs to specific products, indications, populations, and current labels.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on the current Saxenda label, LEADER, and FDA product records."}],"whatItIs":"Liraglutide is a modified GLP-1 analogue used in prescription medicines. The ingredient name alone does not specify the product, indication, formulation, or labeled population.","whatWeKnow":"Randomized trials and FDA-reviewed labels support specific outcomes. LEADER studied cardiovascular outcomes in adults with type 2 diabetes at high cardiovascular risk. Saxenda has a separate chronic weight-management label.","whatWeDoNotKnow":"Those results do not establish identical benefit for every person, an anti-aging effect, or equivalence between approved products and compounded, counterfeit, or research-labeled material.","antiDoping":null,"safetyBoundary":"The current label contains important contraindications, warnings, and precautions. This guide does not determine eligibility or provide dose, titration, or product-switching instructions.","relatedSlugs":["semaglutide","tirzepatide","retatrutide"],"claims":[{"claim":"“Liraglutide has established human outcome evidence.”","verdict":"Supported with scope","explanation":"Yes, for defined products, populations, indications, comparators, endpoints, and durations studied in major trials and reviewed labels.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Approved liraglutide products used in the populations and indications studied.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/27295427/","https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s024lbl.pdf"]},{"claim":"“Every product sold as liraglutide is clinically equivalent.”","verdict":"Misleading","explanation":"Approved-product evidence includes product quality and labeling that cannot be assumed for every compounded or unapproved item.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Product identity, formulation, quality, and labeling all matter.","sourceUrls":["https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases"]},{"claim":"“Cardiovascular trial results prove a universal longevity benefit.”","verdict":"Not established","explanation":"LEADER tested a defined cardiovascular composite in a high-risk type 2 diabetes population, not lifespan extension in the general population.","category":"Longevity","evidenceBasis":"Randomized human outcomes","scope":"Adults with type 2 diabetes and high cardiovascular risk in LEADER.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/27295427/"]}],"sources":[{"label":"VICTOZA (liraglutide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022341Orig1s043lbl.pdf","kind":"Drug label","year":2024,"accessedAt":"2026-07-23"},{"label":"SAXENDA (liraglutide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s024lbl.pdf","kind":"Drug label","year":2026,"accessedAt":"2026-07-23"},{"label":"Liraglutide and cardiovascular outcomes in type 2 diabetes","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/27295427/","kind":"Randomized trial","year":2016,"accessedAt":"2026-07-23"},{"label":"Drug approvals and databases","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"retatrutide","name":"Retatrutide","aliases":["RETA","LY3437943","triple G agonist","triple hormone agonist"],"className":"GIP, GLP-1, and glucagon receptor agonist","family":"Metabolic peptide medicines","sequenceLabel":"39 amino acids · investigational triple-receptor agonist","tier":"Emerging","evidenceContext":"Investigational human outcomes","statusLine":"Investigational in the United States; no FDA-approved retatrutide product","productContext":"Retatrutide is a clinical-development molecule. Trial material made under a study protocol is not evidence that internet products with the same name have the same identity or quality.","approvedProducts":[],"indications":["Investigational obesity and metabolic-disease programs"],"profile":{"humanOutcomes":{"level":"Moderate","note":"A peer-reviewed phase 2 obesity trial and multiple sponsor-reported phase 3 topline readouts show substantial human outcome signals, while full confirmatory publication and regulatory review remain incomplete."},"humanPharmacology":{"level":"Moderate","note":"Human dose-response and adverse-event data exist, but the development program is not complete."},"safetyKnowledge":{"level":"Limited","note":"Phase 2 exposure cannot define the full safety profile, rare risks, or long-term benefit-risk balance."},"productCertainty":{"level":"Limited","note":"High for documented trial material; low for products marketed outside authorized research."}},"oneLine":"A triple-receptor investigational peptide with meaningful late-stage human results but no approved product or completed regulatory review.","reviewedAt":"July 24, 2026","reviewedAtISO":"2026-07-24","reviewHistory":[{"date":"2026-07-24","note":"Added Lilly's July 2026 Phase 3 topline disclosures and rechecked current investigational and product-status boundaries."},{"date":"2026-07-23","note":"Checked against the phase 2 publication and the June 2026 TRIUMPH-1 registry update: study complete, no summary results posted."}],"whatItIs":"Retatrutide is an investigational agonist of GIP, GLP-1, and glucagon receptors. It is not the same molecule as semaglutide or tirzepatide, and it is not an FDA-approved medicine.","whatWeKnow":"A 48-week randomized phase 2 trial reported dose-dependent weight reduction. In July 2026, Lilly also announced positive topline results from multiple Phase 3 TRIUMPH trials, including defined obesity populations with and without type 2 diabetes or established cardiovascular disease.","whatWeDoNotKnow":"Topline disclosures are not a substitute for complete peer-reviewed reports or FDA review. Retatrutide remains investigational, other outcomes programs remain active, and the available records do not establish long-term benefit-risk, rare harms, broad real-world effectiveness, or the identity of material sold outside clinical trials.","antiDoping":null,"safetyBoundary":"An investigational molecule is not a self-treatment category. This guide does not provide trial-drug access, sourcing, dosing, injection, or combination instructions.","relatedSlugs":["tirzepatide","semaglutide","liraglutide"],"claims":[{"claim":"“Retatrutide caused weight loss in a randomized human trial.”","verdict":"Supported with scope","explanation":"The phase 2 trial reported dose-dependent weight reduction over 48 weeks in a defined adult population.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Adults meeting the phase 2 obesity-trial criteria over 48 weeks.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/37366315/"]},{"claim":"“Retatrutide is FDA-approved.”","verdict":"Misleading","explanation":"It remains investigational. Positive trial results and sponsor announcements are not FDA marketing approval.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"United States regulatory status as reviewed July 24, 2026.","sourceUrls":["https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"]},{"claim":"“Research retatrutide sold online is the same as clinical-trial material.”","verdict":"Not established","explanation":"A matching label name does not establish sequence, purity, sterility, formulation, storage, or clinical equivalence.","category":"Product equivalence","evidenceBasis":"No reliable human outcome evidence","scope":"Products outside an authorized clinical-development supply chain.","sourceUrls":["https://clinicaltrials.gov/study/NCT05929066","https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"]}],"sources":[{"label":"LY3437943 in people with type 2 diabetes: a phase 1b randomized trial","publisher":"PubMed · The Lancet","url":"https://pubmed.ncbi.nlm.nih.gov/36354040/","kind":"Human pharmacology","year":2022,"accessedAt":"2026-07-23"},{"label":"Retatrutide for people with type 2 diabetes: a phase 2 randomized trial","publisher":"PubMed · The Lancet","url":"https://pubmed.ncbi.nlm.nih.gov/37385280/","kind":"Randomized trial","year":2023,"accessedAt":"2026-07-23"},{"label":"Triple-hormone-receptor agonist retatrutide for obesity: a phase 2 trial","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/37366315/","kind":"Randomized trial","year":2023,"accessedAt":"2026-07-23"},{"label":"Retatrutide for metabolic dysfunction-associated steatotic liver disease","publisher":"PubMed · Nature Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/38858523/","kind":"Randomized trial","year":2024,"accessedAt":"2026-07-23"},{"label":"TRIUMPH-1 phase 3 study record","publisher":"ClinicalTrials.gov","url":"https://clinicaltrials.gov/study/NCT05929066","kind":"Trial registry","year":2026,"accessedAt":"2026-07-23"},{"label":"TRIUMPH-2 phase 3 study record","publisher":"ClinicalTrials.gov","url":"https://clinicaltrials.gov/study/NCT05929079","kind":"Trial registry","year":2026,"accessedAt":"2026-07-23"},{"label":"TRIUMPH-3 phase 3 study record","publisher":"ClinicalTrials.gov","url":"https://clinicaltrials.gov/study/NCT05882045","kind":"Trial registry","year":2026,"accessedAt":"2026-07-23"},{"label":"TRIUMPH-1 topline results","publisher":"Eli Lilly and Company","url":"https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss","kind":"Reference","year":2026,"accessedAt":"2026-07-24"},{"label":"TRIUMPH-2 and TRIUMPH-3 topline results","publisher":"Eli Lilly and Company","url":"https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional","kind":"Reference","year":2026,"accessedAt":"2026-07-24"},{"label":"What to know about retatrutide","publisher":"Eli Lilly and Company","url":"https://www.lilly.com/news/stories/what-to-know-about-retatrutide","kind":"Regulatory","year":2026,"accessedAt":"2026-07-24"},{"label":"FDA concerns with unapproved GLP-1 drugs used for weight loss","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","kind":"Regulatory","year":2026,"accessedAt":"2026-07-24"},{"label":"Drug approvals and databases","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-24"}},{"slug":"tesamorelin","name":"Tesamorelin","aliases":["Egrifta SV","Egrifta WR","TH9507","GHRF analogue"],"className":"Growth hormone-releasing factor analogue","family":"Growth signaling","sequenceLabel":"44 amino acids · stabilized GHRF analogue","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"An FDA-approved product exists for a narrow indication","productContext":"Egrifta SV and Egrifta WR are approved, non-substitutable formulations with product-specific labeling. Tesamorelin sold or compounded outside those products is not automatically equivalent.","approvedProducts":["Egrifta SV","Egrifta WR"],"productRecords":[{"name":"Egrifta SV","formulation":"2 mg single-dose vial","route":"Subcutaneous","indicationScope":"Reduction of excess abdominal fat in adults with HIV and lipodystrophy; not indicated for weight-loss management.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf","labelRevision":"2024 label"},{"name":"Egrifta WR","formulation":"11.6 mg single-patient-use multidose vial","route":"Subcutaneous","indicationScope":"Reduction of excess abdominal fat in adults with HIV and lipodystrophy; not indicated for weight-loss management.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf","labelRevision":"March 2025"}],"indications":["Reduction of excess abdominal fat in adults with HIV and lipodystrophy"],"profile":{"humanOutcomes":{"level":"Strong","note":"Phase 3 trials support visceral-adipose-tissue reduction in the labeled HIV population."},"humanPharmacology":{"level":"Strong","note":"The approved label characterizes IGF-1 response, exposure, and product-specific use."},"safetyKnowledge":{"level":"Strong","note":"The label describes neoplasm, glucose, fluid-retention, hypersensitivity, and other risks."},"productCertainty":{"level":"Strong","note":"High for authentic Egrifta SV; no automatic transfer to other formulations."}},"oneLine":"An approved GHRF analogue for a specific HIV-associated body-composition outcome, not a general weight-loss or anti-aging medicine.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Updated for Egrifta SV and Egrifta WR product identity, non-substitutability, phase 3 outcomes, and the 2026 WADA list."}],"whatItIs":"Tesamorelin is a stabilized analogue of human growth hormone-releasing factor. The approved product has a narrow labeled population and outcome.","whatWeKnow":"Controlled trials in adults with HIV-associated abdominal fat accumulation found reductions in visceral adipose tissue. The Egrifta SV and Egrifta WR labels say the products are not indicated for weight-loss management and that long-term cardiovascular safety has not been established. Their formulations are not substitutable.","whatWeDoNotKnow":"Those results do not establish general fat loss, muscle gain, anti-aging benefit, athletic recovery, or equivalent outcomes from compounded products.","antiDoping":"Tesamorelin appears on the 2026 World Anti-Doping Agency Prohibited List within growth-hormone-releasing factors and analogues.","antiDopingReview":{"status":"Prohibited","detail":"Tesamorelin is named as a prohibited growth-hormone-releasing hormone analogue on the 2026 WADA Prohibited List.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"safetyBoundary":"This is a prescription drug with population-specific benefits and meaningful monitoring requirements. No dosing, cycling, stacking, or performance-use guidance is provided.","relatedSlugs":["cjc-1295","sermorelin","ipamorelin"],"claims":[{"claim":"“Tesamorelin reduces visceral fat in adults with HIV-associated lipodystrophy.”","verdict":"Supported with scope","explanation":"Phase 3 trials and the product label support this outcome in the labeled population.","category":"Body composition","evidenceBasis":"Randomized human outcomes","scope":"Adults with HIV and excess abdominal fat meeting the trial and label criteria.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/20101189/","https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf"]},{"claim":"“Tesamorelin is an approved general weight-loss drug.”","verdict":"Misleading","explanation":"The label specifically says it is not indicated for weight-loss management.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"The current Egrifta SV and Egrifta WR labels.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf"]},{"claim":"“Tesamorelin is permitted for competitive athletes.”","verdict":"Misleading","explanation":"The 2026 WADA Prohibited List names tesamorelin.","category":"Performance and recovery","evidenceBasis":"Regulatory or product record","scope":"Sport governed by the World Anti-Doping Code.","sourceUrls":["https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list"]}],"sources":[{"label":"EGRIFTA SV (tesamorelin) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf","kind":"Drug label","year":2024,"accessedAt":"2026-07-23"},{"label":"EGRIFTA WR (tesamorelin) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf","kind":"Drug label","year":2025,"accessedAt":"2026-07-23"},{"label":"Tesamorelin in HIV-associated abdominal fat accumulation","publisher":"PubMed · Journal of Acquired Immune Deficiency Syndromes","url":"https://pubmed.ncbi.nlm.nih.gov/20101189/","kind":"Randomized trial","year":2010,"accessedAt":"2026-07-23"},{"label":"2026 Prohibited List","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}]},{"slug":"sermorelin","name":"Sermorelin","aliases":["Geref","GRF 1-29","GHRH(1-29)"],"className":"Growth hormone-releasing hormone analogue","family":"Growth signaling","sequenceLabel":"29 amino acids · GHRH fragment","tier":"Emerging","evidenceContext":"Human pharmacology only","statusLine":"Former FDA-approved products are discontinued; FDA found the withdrawals were not for safety or effectiveness","productContext":"Historical Geref approvals do not mean a currently marketed compounded sermorelin product is FDA-approved or clinically interchangeable with the former product.","approvedProducts":[],"indications":["Historical diagnostic and pediatric growth-hormone-deficiency uses"],"profile":{"humanOutcomes":{"level":"Limited","note":"Older pediatric data exist, but evidence for current anti-aging or body-composition claims is not established."},"humanPharmacology":{"level":"Moderate","note":"Growth-hormone release after GHRH stimulation is biologically and clinically documented."},"safetyKnowledge":{"level":"Limited","note":"Historical product data do not fully characterize modern compounded products or long-term wellness use."},"productCertainty":{"level":"Limited","note":"Historical FDA records are clear; identity and quality of current compounded material are product-specific."}},"oneLine":"A GHRH fragment with historical approvals and real hormone-release pharmacology, but no current approved product and no established anti-aging outcome evidence.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Updated with FDA's 2013 determination that the discontinued Geref products were not withdrawn for safety or effectiveness."}],"whatItIs":"Sermorelin is the 1-29 amino-acid fragment of GHRH. Geref products were once approved and later discontinued. In a 2013 Federal Register determination, FDA concluded that the products were not withdrawn for reasons of safety or effectiveness.","whatWeKnow":"Sermorelin can stimulate growth-hormone release, and older clinical literature reports limited pediatric growth data. That is a pharmacology and historical-product record, not proof of modern wellness claims.","whatWeDoNotKnow":"Reliable trials do not establish broad anti-aging, fat-loss, muscle-gain, sleep, or longevity benefits from currently compounded sermorelin products.","antiDoping":"Sermorelin is named among prohibited GHRH analogues on the 2026 WADA Prohibited List.","antiDopingReview":{"status":"Prohibited","detail":"Sermorelin is named as a prohibited growth-hormone-releasing hormone analogue on the 2026 WADA Prohibited List.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"safetyBoundary":"Historical approval is not a dosing template or a quality certificate for modern products. This guide provides no regimen, injection, or compounding advice.","relatedSlugs":["tesamorelin","cjc-1295","ipamorelin"],"claims":[{"claim":"“Sermorelin was once FDA-approved.”","verdict":"Supported with scope","explanation":"Geref approvals are documented. FDA later determined that the discontinued products were not withdrawn for reasons of safety or effectiveness.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"Historical Geref products, not current compounded sermorelin.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf","https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf"]},{"claim":"“Sermorelin raises growth hormone, so it is proven to slow aging.”","verdict":"Misleading","explanation":"A hormone response is not a patient-centered aging or longevity outcome.","category":"Longevity","evidenceBasis":"Human pharmacology","scope":"Hormone-response evidence cannot establish longer life or slower biological aging.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/18031173/"]},{"claim":"“Compounded sermorelin is an FDA-approved Geref generic.”","verdict":"Misleading","explanation":"The historical product record does not make current compounded products approved or equivalent.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Current products marketed after Geref withdrawal.","sourceUrls":["https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf"]}],"sources":[{"label":"Geref (sermorelin acetate) approval package","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf","kind":"FDA review","year":1991,"accessedAt":"2026-07-23"},{"label":"FDA determination that Geref was not withdrawn for safety or effectiveness","publisher":"Federal Register · U.S. Food and Drug Administration","url":"https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf","kind":"Regulatory","year":2013,"accessedAt":"2026-07-23"},{"label":"Sermorelin in diagnosis and treatment of pediatric growth hormone deficiency","publisher":"PubMed · BioDrugs","url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","kind":"Science review","year":1997,"accessedAt":"2026-07-23"},{"label":"2026 Prohibited List","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[]},{"slug":"tb-500","name":"TB-500","aliases":["TB500","Ac-LKKTETQ","thymosin beta-4 fragment 17-23"],"className":"Synthetic thymosin beta-4 fragment","family":"Recovery and repair claims","sequenceLabel":"7 amino acids · N-terminal acetylated fragment","tier":"Insufficient","evidenceContext":"Preclinical or formulation evidence","statusLine":"No FDA-approved TB-500 drug product","productContext":"FDA identifies TB-500 as a seven-amino-acid fragment, not as interchangeable with full-length thymosin beta-4. Internet naming and certificates do not establish product identity or clinical equivalence.","approvedProducts":[],"indications":["No FDA-approved indication"],"profile":{"humanOutcomes":{"level":"Unclear","note":"FDA found no adequate human clinical outcome evidence for compounded TB-500 wound-healing use."},"humanPharmacology":{"level":"Limited","note":"Fragment identity and laboratory findings do not establish a clinical benefit in people."},"safetyKnowledge":{"level":"Unclear","note":"Human exposure and product-specific safety information are inadequate."},"productCertainty":{"level":"Unclear","note":"Nomenclature, salt form, purity, sterility, and fragment-versus-protein distinctions create major uncertainty."}},"oneLine":"A seven-amino-acid thymosin fragment promoted for repair despite an unresolved human-outcome gap, significant product questions, and anti-doping prohibition.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief uses FDA's July 2026 identity and evidence review before final agency action."}],"whatItIs":"TB-500 is reported as the N-terminal acetylated 17-23 fragment of thymosin beta-4. It is not full-length thymosin beta-4, and evidence about the full protein cannot automatically be transferred to the fragment.","whatWeKnow":"FDA has published a detailed 2026 briefing on identity, characterization, proposed wound-healing use, and evidence gaps. WADA explicitly names TB-500 on the 2026 Prohibited List.","whatWeDoNotKnow":"Reliable controlled human trials do not establish faster tendon, muscle, or wound healing from TB-500. Safety, purity, sterility, long-term effects, and equivalence of marketed material remain uncertain.","antiDoping":"TB-500 and thymosin beta-4 are named on the 2026 World Anti-Doping Agency Prohibited List.","antiDopingReview":{"status":"Prohibited","detail":"TB-500 is named as a prohibited thymosin-beta-4 derivative on the 2026 WADA Prohibited List.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"safetyBoundary":"This is not an invitation to experiment. The guide provides no sourcing, reconstitution, injection, cycle, stack, or injury-treatment instructions.","relatedSlugs":["bpc-157","ghk-cu"],"claims":[{"claim":"“TB-500 is the same thing as thymosin beta-4.”","verdict":"Misleading","explanation":"FDA describes TB-500 as a seven-amino-acid fragment of the much larger thymosin beta-4 molecule.","category":"Mechanism and biomarkers","evidenceBasis":"Regulatory or product record","scope":"Chemical identity, not a claim about all possible biological activity.","sourceUrls":["https://www.fda.gov/media/193349/download"]},{"claim":"“TB-500 accelerates tendon and muscle healing in people.”","verdict":"Not established","explanation":"The FDA evidence review did not identify adequate human outcome evidence for wound-healing use.","category":"Performance and recovery","evidenceBasis":"No reliable human outcome evidence","scope":"Clinical tendon, muscle, and wound-healing outcomes in people.","sourceUrls":["https://www.fda.gov/media/193349/download"]},{"claim":"“TB-500 is allowed in tested sport.”","verdict":"Misleading","explanation":"TB-500 is named on the current WADA Prohibited List.","category":"Performance and recovery","evidenceBasis":"Regulatory or product record","scope":"Sport governed by the World Anti-Doping Code.","sourceUrls":["https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list"]}],"sources":[{"label":"FDA briefing document for TB-500-related bulk drug substances","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/193349/download","kind":"FDA review","year":2026,"accessedAt":"2026-07-23"},{"label":"TB-500 substance record","publisher":"U.S. Food and Drug Administration Global Substance Registration System","url":"https://precision.fda.gov/uniisearch/srs/unii/QHK6Z47GTG","kind":"Reference","year":2026,"accessedAt":"2026-07-23"},{"label":"2026 Prohibited List","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[]},{"slug":"ghk-cu","name":"GHK-Cu","aliases":["copper tripeptide-1","glycyl-L-histidyl-L-lysine copper","GHK copper"],"className":"Copper-binding tripeptide complex","family":"Recovery and repair claims","sequenceLabel":"3 amino acids complexed with copper","tier":"Emerging","evidenceContext":"Preclinical or formulation evidence","statusLine":"No FDA-approved injectable GHK-Cu drug product","productContext":"Topical formulations, compounded non-injectable products, and injectable products are different evidence questions. FDA separately flags injectable GHK-Cu risks.","approvedProducts":[],"indications":["No FDA-approved drug indication"],"profile":{"humanOutcomes":{"level":"Limited","note":"Small formulation-specific human studies exist, but broad regenerative and anti-aging outcomes are not established."},"humanPharmacology":{"level":"Limited","note":"Copper binding and cell-level signaling are biologically plausible but not equivalent to clinical benefit."},"safetyKnowledge":{"level":"Limited","note":"Human information is limited, and FDA identifies injectable immunogenicity and impurity concerns."},"productCertainty":{"level":"Unclear","note":"Formulation and route strongly affect what evidence can be transferred."}},"oneLine":"A copper-binding tripeptide with topical and laboratory research that does not validate injectable, whole-body, or longevity claims.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief separates topical formulation studies from injectable-product claims."}],"whatItIs":"GHK-Cu is a copper complex of the tripeptide glycyl-L-histidyl-L-lysine. Cosmetic ingredient use, topical study formulations, and compounded injections are not interchangeable categories.","whatWeKnow":"A small randomized topical study after laser resurfacing had 13 completers. It found no significant between-group improvement in erythema, wrinkles, or objectively assessed skin quality, although questionnaire-reported satisfaction was higher in the GHK-Cu group. FDA says human data are limited and flags potential immunogenicity from aggregates and peptide-related impurities for injectable routes.","whatWeDoNotKnow":"The evidence does not establish that injected GHK-Cu rejuvenates organs, repairs systemic injury, reverses aging, or produces the same effects as a studied topical formulation.","antiDoping":null,"safetyBoundary":"Route and formulation are part of the claim. This guide does not provide injectable-use, compounding, cosmetic-treatment, or wound-care instructions.","relatedSlugs":["tb-500","bpc-157","epitalon"],"claims":[{"claim":"“GHK-Cu has been studied in people.”","verdict":"Supported with scope","explanation":"Yes, but the cited topical trial had 13 completers, found no significant objective improvement in erythema, wrinkles, or skin quality, and reported higher patient satisfaction. It does not establish broader outcomes or other routes.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"A specific topical copper-tripeptide formulation after CO2 laser resurfacing.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/16847171/"]},{"claim":"“Topical GHK-Cu evidence proves injectable GHK-Cu works systemically.”","verdict":"Misleading","explanation":"Route, formulation, exposure, product quality, and endpoint differ. Evidence cannot be transferred by ingredient name alone.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Topical study formulations versus compounded injectable products.","sourceUrls":["https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"]},{"claim":"“Injectable GHK-Cu is proven safe.”","verdict":"Not established","explanation":"FDA identifies limited human data and potential immunogenicity related to aggregation and peptide impurities.","category":"Safety","evidenceBasis":"Regulatory or product record","scope":"Compounded injectable GHK-Cu.","sourceUrls":["https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"]}],"sources":[{"label":"Bulk drug substances that may present significant safety risks","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin","publisher":"PubMed · Archives of Facial Plastic Surgery","url":"https://pubmed.ncbi.nlm.nih.gov/16847171/","kind":"Randomized trial","year":2006,"accessedAt":"2026-07-23"},{"label":"503A bulk drug substances under evaluation","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/94155/download?attachment=","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"mots-c","name":"MOTS-c","aliases":["MOTS-c peptide","mitochondrial open reading frame 12S rRNA-c"],"className":"Mitochondria-derived peptide","family":"Longevity and cellular signaling","sequenceLabel":"16 amino acids · mitochondria-encoded peptide","tier":"Insufficient","evidenceContext":"Preclinical or formulation evidence","statusLine":"No FDA-approved MOTS-c drug product","productContext":"A recognized substance identity and compelling animal biology do not establish the identity, quality, safety, or efficacy of a marketed injectable product.","approvedProducts":[],"indications":["No FDA-approved indication"],"profile":{"humanOutcomes":{"level":"Unclear","note":"FDA's 2026 review found no published studies administering MOTS-c drug products to humans."},"humanPharmacology":{"level":"Limited","note":"Preclinical metabolic and mitochondrial signals are hypothesis-generating."},"safetyKnowledge":{"level":"Unclear","note":"Human exposure, immunogenicity, long-term effects, and route-specific safety are unresolved."},"productCertainty":{"level":"Unclear","note":"Substance naming does not establish purity, sterility, or product equivalence."}},"oneLine":"A mitochondria-derived peptide with active preclinical research but no established human drug-product outcomes or adequate clinical safety record.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief reflects FDA's July 2026 evidence review before final agency action."}],"whatItIs":"MOTS-c is a 16-amino-acid peptide encoded within mitochondrial 12S rRNA. Its discovery and animal research are scientifically interesting, but discovery is not a clinical outcome.","whatWeKnow":"FDA's current review describes metabolic and bone-related preclinical research and found no published study in which a MOTS-c drug product was administered to humans.","whatWeDoNotKnow":"There is no established human evidence for weight loss, exercise enhancement, glucose control, osteoporosis treatment, DNA repair, or slower aging from a MOTS-c drug product.","antiDoping":"MOTS-c is prohibited under the current WADA framework as an AMPK activator within hormone and metabolic modulators.","antiDopingReview":{"status":"Prohibited","detail":"MOTS-c is prohibited as an AMPK activator under the hormone and metabolic modulators section of the 2026 WADA Prohibited List.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"safetyBoundary":"No dosing, injection, sourcing, or performance-use guidance is provided. The absence of human exposure data is a reason for caution, not a blank space to fill with anecdotes.","relatedSlugs":["epitalon","retatrutide","aod-9604"],"claims":[{"claim":"“MOTS-c has promising metabolic effects in animal research.”","verdict":"Supported with scope","explanation":"Preclinical metabolic findings are a real research signal, but they remain preclinical.","category":"Mechanism and biomarkers","evidenceBasis":"Preclinical evidence","scope":"Laboratory and animal research, not patient outcomes.","sourceUrls":["https://www.fda.gov/media/193347/download"]},{"claim":"“MOTS-c produces weight loss in people.”","verdict":"Not established","explanation":"FDA found no published human drug-product administration studies in its 2026 review.","category":"Body composition","evidenceBasis":"No reliable human outcome evidence","scope":"Clinical weight outcomes from administered MOTS-c drug products.","sourceUrls":["https://www.fda.gov/media/193347/download"]},{"claim":"“A UNII number means MOTS-c is FDA-approved.”","verdict":"Misleading","explanation":"FDA's substance registry explicitly states that UNII availability does not imply regulatory review or approval.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"Substance identification versus drug-product approval.","sourceUrls":["https://precision.fda.gov/uniisearch/srs/unii/A5CV6JFB78"]}],"sources":[{"label":"FDA briefing document for MOTS-c-related bulk drug substances","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/193347/download","kind":"FDA review","year":2026,"accessedAt":"2026-07-23"},{"label":"MOTS-c substance record","publisher":"U.S. Food and Drug Administration Global Substance Registration System","url":"https://precision.fda.gov/uniisearch/srs/unii/A5CV6JFB78","kind":"Reference","year":2026,"accessedAt":"2026-07-23"},{"label":"Bulk drug substances that may present significant safety risks","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"2026 Prohibited List","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[]},{"slug":"aod-9604","name":"AOD-9604","aliases":["AOD9604","lipotropin","hGH fragment 176-191"],"className":"Modified growth-hormone fragment","family":"Metabolic peptide medicines","sequenceLabel":"16 amino acids · modified hGH C-terminal fragment","tier":"Insufficient","evidenceContext":"Investigational human outcomes","statusLine":"No FDA-approved AOD-9604 drug product","productContext":"Oral clinical-study material, compounded injections, and transdermal products are not interchangeable. FDA found route-specific evidence gaps.","approvedProducts":[],"indications":["No FDA-approved indication"],"profile":{"humanOutcomes":{"level":"Limited","note":"Older obesity studies exposed hundreds of participants, but the evidence did not establish an approved weight-loss use."},"humanPharmacology":{"level":"Limited","note":"FDA found insufficient pharmacokinetic and pharmacodynamic information for proposed uses and routes."},"safetyKnowledge":{"level":"Limited","note":"Clinical safety reporting is incomplete, and FDA identifies immunogenicity and impurity concerns."},"productCertainty":{"level":"Unclear","note":"Identity, route, formulation, sterility, and comparability of compounded products are uncertain."}},"oneLine":"A modified growth-hormone fragment studied in obesity programs without an approved use and with unresolved route, product, and safety questions.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on FDA's 2024 compounding review and current safety-risk page."}],"whatItIs":"AOD-9604 is a modified fragment related to amino acids 176-191 of human growth hormone. It is not full-length growth hormone.","whatWeKnow":"FDA reviewed several human obesity studies, including larger oral programs, and documented the available adverse-event reporting. That confirms human exposure, not an established benefit.","whatWeDoNotKnow":"The record does not establish meaningful weight loss, long-term benefit, or safety for injectable or transdermal products. FDA found no human information for some proposed routes.","antiDoping":"AOD-9604 is named as a prohibited growth-hormone fragment on the 2026 WADA Prohibited List.","antiDopingReview":{"status":"Prohibited","detail":"AOD-9604 is named as a prohibited growth-hormone fragment on the 2026 WADA Prohibited List.","sourceUrl":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","reviewedAtISO":"2026-07-23"},"safetyBoundary":"This brief does not convert an incomplete development program into a self-experiment. No sourcing, reconstitution, injection, or weight-loss regimen is provided.","relatedSlugs":["mots-c","semaglutide","retatrutide"],"claims":[{"claim":"“AOD-9604 has been given to people in clinical studies.”","verdict":"Supported with scope","explanation":"FDA's review describes several human studies, primarily using oral or intravenous routes.","category":"Clinical outcomes","evidenceBasis":"Regulatory or product record","scope":"Historical study products and routes described in FDA's review.","sourceUrls":["https://www.fda.gov/media/183584/download"]},{"claim":"“Human exposure proves AOD-9604 is an effective fat-loss drug.”","verdict":"Misleading","explanation":"Exposure and tolerability data do not establish a clinically meaningful weight-loss outcome.","category":"Body composition","evidenceBasis":"No reliable human outcome evidence","scope":"Weight-loss efficacy, not merely participation in a study.","sourceUrls":["https://www.fda.gov/media/183584/download"]},{"claim":"“Injectable AOD-9604 has a well-characterized safety profile.”","verdict":"Not established","explanation":"FDA identifies limited safety data, immunogenicity concerns, and missing information for proposed injectable use.","category":"Safety","evidenceBasis":"Regulatory or product record","scope":"Compounded injectable AOD-9604.","sourceUrls":["https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"]}],"sources":[{"label":"FDA briefing document for AOD-9604-related bulk drug substances","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/183584/download","kind":"FDA review","year":2024,"accessedAt":"2026-07-23"},{"label":"Bulk drug substances that may present significant safety risks","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"},{"label":"Sterile compounded AOD-9604 recall for lack of sterility assurance","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack-0","kind":"Regulatory","year":2021,"accessedAt":"2026-07-23"},{"label":"2026 Prohibited List","publisher":"World Anti-Doping Agency","url":"https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list","kind":"Anti-doping","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[]},{"slug":"epitalon","name":"Epitalon","aliases":["Epithalon","AEDG","epitalon acetate"],"className":"Synthetic tetrapeptide","family":"Longevity and cellular signaling","sequenceLabel":"4 amino acids · Ala-Glu-Asp-Gly","tier":"Insufficient","evidenceContext":"Preclinical or formulation evidence","statusLine":"No FDA-approved epitalon drug product","productContext":"Epitalon, epitalon acetate, and older pineal extracts such as epithalamin are not automatically interchangeable evidence objects.","approvedProducts":[],"indications":["No FDA-approved indication"],"profile":{"humanOutcomes":{"level":"Unclear","note":"FDA found no studies establishing insomnia outcomes for the nominated epitalon substances and route."},"humanPharmacology":{"level":"Limited","note":"Melatonin and cell-line findings are indirect and do not establish patient benefit."},"safetyKnowledge":{"level":"Unclear","note":"Human product, route, exposure, impurity, and long-term safety data are inadequate."},"productCertainty":{"level":"Unclear","note":"Evidence often mixes epitalon, epitalon acetate, and non-identical pineal preparations."}},"oneLine":"A tetrapeptide promoted for sleep and longevity despite identity transfer problems and no established insomnia or lifespan outcome evidence.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief reflects FDA's July 2026 insomnia-focused evidence review before final agency action."}],"whatItIs":"Epitalon is the tetrapeptide Ala-Glu-Asp-Gly. It is frequently discussed alongside epithalamin, a pineal preparation, but those are not the same intervention.","whatWeKnow":"Laboratory work has reported telomere-related effects in human cell lines. FDA's current review found melatonin-related information but no clinical insomnia studies using the nominated substances by the proposed route.","whatWeDoNotKnow":"Cell-line telomere changes do not establish slower aging, longer life, cancer prevention, or improved health in people. Evidence from epithalamin cannot be silently reassigned to epitalon.","antiDoping":null,"safetyBoundary":"Longevity claims demand long-duration human outcomes, not only mechanisms. This guide provides no injectable, sleep-treatment, or anti-aging regimen.","relatedSlugs":["mots-c","ghk-cu"],"claims":[{"claim":"“Epitalon changes telomere biology in human cell lines.”","verdict":"Supported with scope","explanation":"A 2025 laboratory study reported telomere-length effects in cultured human cell lines.","category":"Mechanism and biomarkers","evidenceBasis":"Preclinical evidence","scope":"Cultured cell lines, not health outcomes in treated people.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/40908429/"]},{"claim":"“Epitalon is proven to treat insomnia.”","verdict":"Not established","explanation":"FDA did not identify clinical insomnia studies of the nominated epitalon substances by the proposed route.","category":"Clinical outcomes","evidenceBasis":"No reliable human outcome evidence","scope":"Adults with insomnia assessed using clinical sleep outcomes.","sourceUrls":["https://www.fda.gov/media/193345/download"]},{"claim":"“Epitalon has been proven to extend human lifespan.”","verdict":"Not established","explanation":"The evidence does not provide reliable product-specific randomized lifespan outcomes for epitalon.","category":"Longevity","evidenceBasis":"No reliable human outcome evidence","scope":"Human lifespan and healthspan outcomes attributable to epitalon.","sourceUrls":["https://www.fda.gov/media/193345/download"]}],"sources":[{"label":"FDA briefing document for epitalon-related bulk drug substances","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/193345/download","kind":"FDA review","year":2026,"accessedAt":"2026-07-23"},{"label":"Epitalon and telomere length in human cell lines","publisher":"PubMed · Biogerontology","url":"https://pubmed.ncbi.nlm.nih.gov/40908429/","kind":"Preclinical","year":2025,"accessedAt":"2026-07-23"},{"label":"July 2026 Pharmacy Compounding Advisory Committee meeting","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"productRecords":[],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"bremelanotide","name":"Bremelanotide","aliases":["PT-141","Vyleesi","bremelanotide acetate"],"className":"Melanocortin receptor agonist","family":"Melanocortin medicines","sequenceLabel":"7 amino acids · cyclic peptide","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"An FDA-approved product exists for a narrow indication","productContext":"Vyleesi is an approved, product-specific presentation. Calling any PT-141 product 'Vyleesi' or transferring its evidence to compounded material is not justified.","approvedProducts":["Vyleesi"],"productRecords":[{"name":"Vyleesi","formulation":"Single-dose autoinjector","route":"Subcutaneous","indicationScope":"Acquired, generalized hypoactive sexual desire disorder in the premenopausal population and circumstances defined in the label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf","labelRevision":"September 2020"}],"indications":["Acquired, generalized hypoactive sexual desire disorder in certain premenopausal women"],"profile":{"humanOutcomes":{"level":"Moderate","note":"Two phase 3 trials support modest changes in prespecified desire and distress endpoints for the labeled population."},"humanPharmacology":{"level":"Strong","note":"Exposure and transient cardiovascular effects are characterized in the approved label."},"safetyKnowledge":{"level":"Strong","note":"The label describes blood-pressure effects, contraindications, nausea, pigmentation, and other risks."},"productCertainty":{"level":"Strong","note":"High for authentic Vyleesi; evidence does not automatically transfer to compounded PT-141."}},"oneLine":"An approved melanocortin medicine for a defined sexual-desire disorder, not a general sexual-performance enhancer.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on the Vyleesi label, RECONNECT trials, and FDA multidisciplinary review."}],"whatItIs":"Bremelanotide is a melanocortin receptor agonist and the active ingredient in Vyleesi. The approved indication has diagnostic, demographic, and exclusion criteria.","whatWeKnow":"The RECONNECT phase 3 trials reported improvements in prespecified desire and distress endpoints in premenopausal women with acquired, generalized HSDD. The label says it is not indicated to enhance sexual performance.","whatWeDoNotKnow":"The evidence does not establish treatment of all causes of low desire, benefit in men or postmenopausal women, universal relationship benefit, or equivalence of compounded PT-141.","antiDoping":null,"safetyBoundary":"The label includes a contraindication for uncontrolled hypertension or known cardiovascular disease and describes transient blood-pressure increases. This guide provides no dosing or injection advice.","relatedSlugs":["afamelanotide"],"claims":[{"claim":"“Bremelanotide is FDA-approved for a specific form of HSDD.”","verdict":"Supported with scope","explanation":"Vyleesi is approved for acquired, generalized HSDD in certain premenopausal women after specified exclusions.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"The population and limitations in the current Vyleesi label.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"]},{"claim":"“PT-141 is an approved sexual-performance enhancer for anyone.”","verdict":"Misleading","explanation":"The label explicitly says the product is not for enhancing sexual performance and is not indicated for men or postmenopausal women.","category":"Clinical outcomes","evidenceBasis":"Regulatory or product record","scope":"Vyleesi's labeled indication and limitations.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"]},{"claim":"“Compounded PT-141 has the same evidence as Vyleesi.”","verdict":"Not established","explanation":"The trial and approval record are product-specific and do not establish equivalence for compounded material.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Compounded or research-labeled bremelanotide products.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf"]}],"sources":[{"label":"VYLEESI (bremelanotide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf","kind":"Drug label","year":2020,"accessedAt":"2026-07-23"},{"label":"Bremelanotide for HSDD: two randomized phase 3 trials","publisher":"PubMed · Obstetrics & Gynecology","url":"https://pubmed.ncbi.nlm.nih.gov/31599840/","kind":"Randomized trial","year":2019,"accessedAt":"2026-07-23"},{"label":"Vyleesi multidisciplinary review","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf","kind":"FDA review","year":2019,"accessedAt":"2026-07-23"}],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"afamelanotide","name":"Afamelanotide","aliases":["Scenesse","Nle4-D-Phe7-alpha-MSH","melanocortin-1 agonist"],"className":"Melanocortin-1 receptor agonist","family":"Melanocortin medicines","sequenceLabel":"13 amino acids · alpha-MSH analogue","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"An FDA-approved implant exists for a rare-disease indication","productContext":"Scenesse is a healthcare-professional-administered implant. It is not equivalent to tanning peptides, compounded injections, or other melanocortin analogues.","approvedProducts":["Scenesse"],"productRecords":[{"name":"Scenesse","formulation":"Controlled-release implant","route":"Subcutaneous implant administered by a trained professional","indicationScope":"Increase pain-free light exposure in adults with erythropoietic protoporphyria and a history of phototoxic reactions.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf","labelRevision":"2024 label"}],"indications":["Increase pain-free light exposure in adults with erythropoietic protoporphyria"],"profile":{"humanOutcomes":{"level":"Strong","note":"Randomized trials support pain-free light-exposure and quality-of-life outcomes in adults with EPP."},"humanPharmacology":{"level":"Strong","note":"The approved implant's pharmacology and melanocortin-1 activity are characterized."},"safetyKnowledge":{"level":"Strong","note":"The label and postauthorization monitoring characterize known risks and skin-monitoring requirements."},"productCertainty":{"level":"Strong","note":"High for authentic Scenesse; low for transfer to other melanocortin products."}},"oneLine":"An approved implant that increases pain-free light exposure in adults with EPP, not a general-purpose tanning or cosmetic peptide.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on the current Scenesse label, pivotal trials, and orphan-drug record."}],"whatItIs":"Afamelanotide is an alpha-melanocyte-stimulating hormone analogue and melanocortin-1 receptor agonist delivered in the approved Scenesse implant.","whatWeKnow":"Randomized trials in erythropoietic protoporphyria reported more pain-free light exposure and improvements in disease-specific quality of life. FDA approved Scenesse for a corresponding adult population.","whatWeDoNotKnow":"The approval does not establish general tanning, cosmetic anti-aging, athletic, or other disease benefits, and it does not validate different melanocortin peptides.","antiDoping":null,"safetyBoundary":"The implant is administered by trained healthcare professionals and the label calls for skin monitoring. This guide provides no implant or cosmetic-use instructions.","relatedSlugs":["bremelanotide"],"claims":[{"claim":"“Afamelanotide increases pain-free light exposure in adults with EPP.”","verdict":"Supported with scope","explanation":"The label and randomized trials support this defined rare-disease outcome.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Adults with a history of phototoxic reactions from erythropoietic protoporphyria.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/26132941/","https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf"]},{"claim":"“Scenesse is an approved cosmetic tanning implant.”","verdict":"Misleading","explanation":"Its approval is for pain-free light exposure in adults with EPP, not cosmetic tanning.","category":"Approval and status","evidenceBasis":"Regulatory or product record","scope":"The current FDA-approved indication.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf"]},{"claim":"“Afamelanotide evidence proves other tanning peptides are safe and effective.”","verdict":"Misleading","explanation":"Different molecules and products require their own identity, quality, safety, and outcome evidence.","category":"Product equivalence","evidenceBasis":"Regulatory or product record","scope":"Other melanocortin analogues and unapproved products.","sourceUrls":["https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=263208"]}],"sources":[{"label":"SCENESSE (afamelanotide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf","kind":"Drug label","year":2024,"accessedAt":"2026-07-23"},{"label":"Afamelanotide for erythropoietic protoporphyria","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/26132941/","kind":"Randomized trial","year":2015,"accessedAt":"2026-07-23"},{"label":"Afamelanotide orphan drug designation and approval","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=263208","kind":"Regulatory","year":2019,"accessedAt":"2026-07-23"}],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"teriparatide","name":"Teriparatide","aliases":["Forteo","PTH 1-34","recombinant human parathyroid hormone 1-34"],"className":"Parathyroid hormone analogue","family":"Bone and tissue peptide medicines","sequenceLabel":"34 amino acids · recombinant PTH fragment","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"FDA-approved products exist for specific osteoporosis populations","productContext":"Teriparatide evidence concerns approved drug products and labeled osteoporosis populations, not every product called PTH 1-34 or every type of fracture.","approvedProducts":["Forteo","approved teriparatide products"],"productRecords":[{"name":"Forteo","formulation":"Prefilled delivery device","route":"Subcutaneous","indicationScope":"Osteoporosis uses in the high-fracture-risk populations defined in the product label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021318s057lbl.pdf","labelRevision":"2024 label"}],"indications":["Osteoporosis treatment in labeled high-fracture-risk populations"],"profile":{"humanOutcomes":{"level":"Strong","note":"Randomized evidence supports vertebral and nonvertebral fracture-risk reduction in defined osteoporosis populations."},"humanPharmacology":{"level":"Strong","note":"Bone-turnover, exposure, and product-specific pharmacology are well characterized."},"safetyKnowledge":{"level":"Strong","note":"Labels describe hypercalcemia, orthostatic hypotension, osteosarcoma risk factors, and other precautions."},"productCertainty":{"level":"Strong","note":"High for authentic approved products used within the label."}},"oneLine":"An established bone-anabolic peptide medicine with fracture-prevention evidence that should not be generalized to every healing claim.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on the current Forteo label and fracture-prevention trial record."}],"whatItIs":"Teriparatide is the biologically active 1-34 fragment of human parathyroid hormone and is used as an anabolic osteoporosis medicine.","whatWeKnow":"Controlled trials and approved labeling support reduction of vertebral and nonvertebral fracture risk in defined high-risk osteoporosis populations.","whatWeDoNotKnow":"That evidence does not prove faster healing for every acute fracture, universal benefit in athletes, or safety outside monitored prescription use.","antiDoping":null,"safetyBoundary":"The label contains important duration, risk-factor, calcium, and monitoring considerations. No dose, injection, or off-label fracture-healing instructions are provided.","relatedSlugs":["abaloparatide"],"claims":[{"claim":"“Teriparatide reduces fracture risk in defined osteoporosis populations.”","verdict":"Supported with scope","explanation":"The pivotal evidence and label support vertebral and nonvertebral fracture-risk reduction in studied high-risk populations.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Labeled osteoporosis populations at high fracture risk.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/11248153/","https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021318s057lbl.pdf"]},{"claim":"“Teriparatide is proven to heal every fracture faster.”","verdict":"Not established","explanation":"Fracture prevention and acute fracture healing are different endpoints, and trial results vary by fracture setting.","category":"Performance and recovery","evidenceBasis":"Randomized human outcomes","scope":"Acute fracture-healing outcomes across all fracture types.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/26932738/"]},{"claim":"“Because teriparatide is a peptide, it has no serious risks.”","verdict":"Misleading","explanation":"The current label includes clinically important warnings, precautions, and population restrictions.","category":"Safety","evidenceBasis":"Regulatory or product record","scope":"Approved teriparatide product use.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021318s057lbl.pdf"]}],"sources":[{"label":"FORTEO (teriparatide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021318s057lbl.pdf","kind":"Drug label","year":2024,"accessedAt":"2026-07-23"},{"label":"Parathyroid hormone for postmenopausal osteoporosis","publisher":"PubMed · New England Journal of Medicine","url":"https://pubmed.ncbi.nlm.nih.gov/11248153/","kind":"Randomized trial","year":2001,"accessedAt":"2026-07-23"},{"label":"Teriparatide and femoral-neck fracture healing","publisher":"PubMed · Clinical Orthopaedics and Related Research","url":"https://pubmed.ncbi.nlm.nih.gov/26932738/","kind":"Randomized trial","year":2016,"accessedAt":"2026-07-23"}],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"abaloparatide","name":"Abaloparatide","aliases":["Tymlos","BA058","PTHrP analogue"],"className":"Parathyroid hormone-related peptide analogue","family":"Bone and tissue peptide medicines","sequenceLabel":"34 amino acids · PTHrP analogue","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"An FDA-approved product exists for defined osteoporosis populations","productContext":"Tymlos is a product-specific prescription medicine. Trial findings do not validate unapproved PTHrP analogues or general performance use.","approvedProducts":["Tymlos"],"productRecords":[{"name":"Tymlos","formulation":"Injection pen","route":"Subcutaneous","indicationScope":"Osteoporosis uses in the high-fracture-risk populations defined in the product label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf","labelRevision":"2025 label"}],"indications":["Osteoporosis treatment or bone-density increase in labeled high-risk populations"],"profile":{"humanOutcomes":{"level":"Strong","note":"The ACTIVE phase 3 trial supports fracture-risk reduction in postmenopausal women with osteoporosis."},"humanPharmacology":{"level":"Strong","note":"Approved labeling characterizes PTH1-receptor activity, exposure, and bone-turnover effects."},"safetyKnowledge":{"level":"Strong","note":"Known risks and monitoring are described in the current product label."},"productCertainty":{"level":"Strong","note":"High for authentic Tymlos used within the approved label."}},"oneLine":"An approved bone-anabolic peptide with fracture outcome evidence in defined osteoporosis populations and product-specific safety limits.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on the 2025 Tymlos label and ACTIVE phase 3 trial."}],"whatItIs":"Abaloparatide is a synthetic analogue of parathyroid hormone-related peptide that activates the PTH1 receptor and is used as a bone-anabolic medicine.","whatWeKnow":"ACTIVE randomized postmenopausal women with osteoporosis to abaloparatide, placebo, or open-label teriparatide. Abaloparatide reduced new vertebral and nonvertebral fractures versus placebo over 18 months.","whatWeDoNotKnow":"The result does not establish universal superiority over every osteoporosis medicine, enhancement in healthy people, or improved healing of every acute injury.","antiDoping":null,"safetyBoundary":"This is a prescription osteoporosis medicine with product-specific warnings and use limits. No dose, injection, or performance guidance is provided.","relatedSlugs":["teriparatide"],"claims":[{"claim":"“Abaloparatide reduced fractures in a randomized phase 3 trial.”","verdict":"Supported with scope","explanation":"ACTIVE found fewer new vertebral and nonvertebral fractures versus placebo in postmenopausal women with osteoporosis.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Postmenopausal women with osteoporosis at fracture risk over 18 months.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/27533157/"]},{"claim":"“Abaloparatide is proven to improve bone outcomes in every population.”","verdict":"Not established","explanation":"Approved indications and trial populations define the evidence boundary.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Populations outside the current label and pivotal trial.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf"]},{"claim":"“An anabolic bone effect means abaloparatide is a safe performance enhancer.”","verdict":"Misleading","explanation":"A prescription osteoporosis benefit-risk assessment does not establish safe enhancement in healthy people.","category":"Performance and recovery","evidenceBasis":"Regulatory or product record","scope":"Healthy or athletic performance use.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf"]}],"sources":[{"label":"TYMLOS (abaloparatide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf","kind":"Drug label","year":2025,"accessedAt":"2026-07-23"},{"label":"Abaloparatide vs placebo on new vertebral fractures: ACTIVE","publisher":"PubMed · JAMA","url":"https://pubmed.ncbi.nlm.nih.gov/27533157/","kind":"Randomized trial","year":2016,"accessedAt":"2026-07-23"},{"label":"Drug approvals and databases","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases","kind":"Regulatory","year":2026,"accessedAt":"2026-07-23"}],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}},{"slug":"teduglutide","name":"Teduglutide","aliases":["Gattex","ALX-0600","GLP-2 analogue"],"className":"Glucagon-like peptide-2 analogue","family":"Gut and intestinal peptide medicines","sequenceLabel":"33 amino acids · DPP-4-resistant GLP-2 analogue","tier":"Established","evidenceContext":"Approved human outcomes","statusLine":"An FDA-approved product exists for short bowel syndrome","productContext":"Gattex is a labeled prescription product used with structured monitoring. Its evidence does not establish general gut healing or equivalence for compounded GLP-2 analogues.","approvedProducts":["Gattex"],"productRecords":[{"name":"Gattex","formulation":"Powder and diluent for injection","route":"Subcutaneous","indicationScope":"Short bowel syndrome with parenteral-support dependence in the adult and pediatric populations defined in the label.","labelUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203441s024lbl.pdf","labelRevision":"2025 label"}],"indications":["Short bowel syndrome with dependence on parenteral support in labeled adults and children"],"profile":{"humanOutcomes":{"level":"Strong","note":"Randomized trials support reduction in parenteral-support requirements for short bowel syndrome."},"humanPharmacology":{"level":"Strong","note":"Intestinal absorption, exposure, and product effects are characterized in the label and trials."},"safetyKnowledge":{"level":"Strong","note":"The label addresses neoplastic growth, obstruction, biliary and pancreatic disease, and fluid imbalance."},"productCertainty":{"level":"Strong","note":"High for authentic Gattex used within its monitoring program."}},"oneLine":"An established GLP-2 medicine that can reduce parenteral-support needs in short bowel syndrome, with intensive product-specific monitoring.","reviewedAt":"July 23, 2026","reviewedAtISO":"2026-07-23","reviewHistory":[{"date":"2026-07-23","note":"Initial brief based on the 2025 Gattex label, randomized trial, and orphan-drug record."}],"whatItIs":"Teduglutide is a DPP-4-resistant analogue of GLP-2 that promotes intestinal absorptive capacity. Gattex is approved for people with short bowel syndrome who depend on parenteral support.","whatWeKnow":"Randomized trials found reductions in parenteral fluid or nutrition requirements for some participants. The product label defines required screening and ongoing monitoring.","whatWeDoNotKnow":"The evidence does not establish broad treatment of leaky gut, inflammatory symptoms, wellness, or mucosal repair in people without the labeled syndrome.","antiDoping":null,"safetyBoundary":"Potential acceleration of neoplastic growth and other serious risks make this a monitored prescription therapy. No dosing, reconstitution, or self-treatment guidance is provided.","relatedSlugs":["liraglutide","semaglutide"],"claims":[{"claim":"“Teduglutide can reduce parenteral-support needs in short bowel syndrome.”","verdict":"Supported with scope","explanation":"Controlled trials and the Gattex label support this outcome in dependent short-bowel-syndrome populations.","category":"Clinical outcomes","evidenceBasis":"Randomized human outcomes","scope":"Adults and labeled pediatric populations with short bowel syndrome dependent on parenteral support.","sourceUrls":["https://pubmed.ncbi.nlm.nih.gov/22982184/","https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203441s024lbl.pdf"]},{"claim":"“Teduglutide is a general gut-healing peptide.”","verdict":"Misleading","explanation":"The approved indication and outcome are specific to short bowel syndrome with parenteral-support dependence.","category":"Clinical outcomes","evidenceBasis":"Regulatory or product record","scope":"The current Gattex indication.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203441s024lbl.pdf"]},{"claim":"“Because teduglutide promotes intestinal growth, it is low risk.”","verdict":"Misleading","explanation":"The same biological activity underlies important warnings, including potential acceleration of neoplastic growth.","category":"Safety","evidenceBasis":"Regulatory or product record","scope":"Approved Gattex use with required screening and monitoring.","sourceUrls":["https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203441s024lbl.pdf"]}],"sources":[{"label":"GATTEX (teduglutide) prescribing information","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203441s024lbl.pdf","kind":"Drug label","year":2025,"accessedAt":"2026-07-23"},{"label":"Teduglutide reduces parenteral support in short bowel syndrome","publisher":"PubMed · Gastroenterology","url":"https://pubmed.ncbi.nlm.nih.gov/22982184/","kind":"Randomized trial","year":2012,"accessedAt":"2026-07-23"},{"label":"Teduglutide orphan drug designation and approval","publisher":"U.S. Food and Drug Administration","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=126999","kind":"Regulatory","year":2019,"accessedAt":"2026-07-23"}],"antiDopingReview":{"status":"Not assessed","detail":"This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.","sourceUrl":null,"reviewedAtISO":"2026-07-23"}}]}