| Human outcomesDo people experience a meaningful benefit? | Strong Large controlled programs support specific approved indications. | Strong Long-term randomized evidence supports monitored insulin strategies for defined diabetes populations. | Strong Large randomized programs support defined glycemic and chronic weight-management outcomes. | Limited Small uncontrolled pilots cannot establish a patient benefit. | Limited Human studies measured hormone responses, not durable patient outcomes. | Limited A phase 2 trial did not show significant benefit on its key efficacy endpoint. | Strong Large randomized programs support defined glycemic, cardiovascular, and weight-management outcomes. | Moderate 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. | Strong Phase 3 trials support visceral-adipose-tissue reduction in the labeled HIV population. | Limited Older pediatric data exist, but evidence for current anti-aging or body-composition claims is not established. | Unclear FDA found no adequate human clinical outcome evidence for compounded TB-500 wound-healing use. | Limited Small formulation-specific human studies exist, but broad regenerative and anti-aging outcomes are not established. | Unclear FDA's 2026 review found no published studies administering MOTS-c drug products to humans. | Limited Older obesity studies exposed hundreds of participants, but the evidence did not establish an approved weight-loss use. | Unclear FDA found no studies establishing insomnia outcomes for the nominated epitalon substances and route. | Moderate Two phase 3 trials support modest changes in prespecified desire and distress endpoints for the labeled population. | Strong Randomized trials support pain-free light-exposure and quality-of-life outcomes in adults with EPP. | Strong Randomized evidence supports vertebral and nonvertebral fracture-risk reduction in defined osteoporosis populations. | Strong The ACTIVE phase 3 trial supports fracture-risk reduction in postmenopausal women with osteoporosis. | Strong Randomized trials support reduction in parenteral-support requirements for short bowel syndrome. |
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| Human pharmacologyDo exposure, mechanisms, or biomarkers behave as expected? | Strong Pharmacology and exposure are extensively characterized for approved products. | Strong Product-specific onset, peak, duration, and exposure are extensively characterized. | Strong Pharmacology and exposure are extensively characterized for approved products. | Limited Human exposure and pharmacokinetic characterization remain sparse. | Moderate Randomized studies show sustained GH and IGF-1 biomarker effects in healthy adults. | Moderate Dose-escalation work characterizes short-lived GH release in healthy volunteers. | Strong Approved labels characterize product-specific exposure, pharmacodynamics, and interactions. | Moderate Human dose-response and adverse-event data exist, but the development program is not complete. | Strong The approved label characterizes IGF-1 response, exposure, and product-specific use. | Moderate Growth-hormone release after GHRH stimulation is biologically and clinically documented. | Limited Fragment identity and laboratory findings do not establish a clinical benefit in people. | Limited Copper binding and cell-level signaling are biologically plausible but not equivalent to clinical benefit. | Limited Preclinical metabolic and mitochondrial signals are hypothesis-generating. | Limited FDA found insufficient pharmacokinetic and pharmacodynamic information for proposed uses and routes. | Limited Melatonin and cell-line findings are indirect and do not establish patient benefit. | Strong Exposure and transient cardiovascular effects are characterized in the approved label. | Strong The approved implant's pharmacology and melanocortin-1 activity are characterized. | Strong Bone-turnover, exposure, and product-specific pharmacology are well characterized. | Strong Approved labeling characterizes PTH1-receptor activity, exposure, and bone-turnover effects. | Strong Intestinal absorption, exposure, and product effects are characterized in the label and trials. |
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| Safety knowledgeHow well are risks characterized in people? | Strong Approved labels describe established risks, monitoring, and contraindications. | Strong Labels and decades of clinical use characterize major risks, especially hypoglycemia. | Strong Current product labels describe boxed warnings, contraindications, precautions, and adverse reactions. | Limited The human safety dataset is too small for confident risk estimates. | Limited Short studies exist, while FDA identifies serious adverse-event and impurity concerns. | Limited Route-specific data are sparse and FDA identifies serious safety concerns. | Strong Current labels describe contraindications, warnings, adverse reactions, and monitoring. | Limited Phase 2 exposure cannot define the full safety profile, rare risks, or long-term benefit-risk balance. | Strong The label describes neoplasm, glucose, fluid-retention, hypersensitivity, and other risks. | Limited Historical product data do not fully characterize modern compounded products or long-term wellness use. | Unclear Human exposure and product-specific safety information are inadequate. | Limited Human information is limited, and FDA identifies injectable immunogenicity and impurity concerns. | Unclear Human exposure, immunogenicity, long-term effects, and route-specific safety are unresolved. | Limited Clinical safety reporting is incomplete, and FDA identifies immunogenicity and impurity concerns. | Unclear Human product, route, exposure, impurity, and long-term safety data are inadequate. | Strong The label describes blood-pressure effects, contraindications, nausea, pigmentation, and other risks. | Strong The label and postauthorization monitoring characterize known risks and skin-monitoring requirements. | Strong Labels describe hypercalcemia, orthostatic hypotension, osteosarcoma risk factors, and other precautions. | Strong Known risks and monitoring are described in the current product label. | Strong The label addresses neoplastic growth, obstruction, biliary and pancreatic disease, and fluid imbalance. |
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| Product certaintyIs identity, formulation, and quality anchored? | Strong High for an authentic approved product; not transferable to every compounded version. | Strong High for an authentic approved product; the exact product and formulation still matter. | Strong High for an authentic approved product; not transferable to every compounded or counterfeit version. | Unclear No validated approved formulation; identity and purity vary outside formal research. | Unclear CJC-1295 with DAC, without DAC, salts, and combinations are often discussed imprecisely. | Unclear No approved formulation anchors identity, purity, or equivalence in the consumer market. | Strong High for authentic approved products; evidence does not transfer automatically to unapproved versions. | Limited High for documented trial material; low for products marketed outside authorized research. | Strong High for authentic Egrifta SV; no automatic transfer to other formulations. | Limited Historical FDA records are clear; identity and quality of current compounded material are product-specific. | Unclear Nomenclature, salt form, purity, sterility, and fragment-versus-protein distinctions create major uncertainty. | Unclear Formulation and route strongly affect what evidence can be transferred. | Unclear Substance naming does not establish purity, sterility, or product equivalence. | Unclear Identity, route, formulation, sterility, and comparability of compounded products are uncertain. | Unclear Evidence often mixes epitalon, epitalon acetate, and non-identical pineal preparations. | Strong High for authentic Vyleesi; evidence does not automatically transfer to compounded PT-141. | Strong High for authentic Scenesse; low for transfer to other melanocortin products. | Strong High for authentic approved products used within the label. | Strong High for authentic Tymlos used within the approved label. | Strong High for authentic Gattex used within its monitoring program. |
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| Regulatory statusHas a specific product been reviewed for a use? | FDA-approved products exist for specific indications | Multiple FDA-approved insulin products and biosimilars exist | FDA-approved products exist for specific indications | Investigational; no approved formulation | Investigational; no approved product identified | Investigational; no approved product identified | FDA-approved products exist for specific indications | Investigational in the United States; no FDA-approved retatrutide product | An FDA-approved product exists for a narrow indication | Former FDA-approved products are discontinued; FDA found the withdrawals were not for safety or effectiveness | No FDA-approved TB-500 drug product | No FDA-approved injectable GHK-Cu drug product | No FDA-approved MOTS-c drug product | No FDA-approved AOD-9604 drug product | No FDA-approved epitalon drug product | An FDA-approved product exists for a narrow indication | An FDA-approved implant exists for a rare-disease indication | FDA-approved products exist for specific osteoporosis populations | An FDA-approved product exists for defined osteoporosis populations | An FDA-approved product exists for short bowel syndrome |
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