Which peptides are FDA-approved? A product-by-product directory.

Short answer: FDA approves exact products

The Food and Drug Administration (FDA) approves exact products. It does not approve a general list of peptide names. Several FDA-approved medicines are built from peptides or peptide analogues. The phrase “FDA-approved peptide” is still incomplete until it names the exact product.

Approval attaches to an application and applicant, active ingredient, dosage form, route, strength or presentation, labeling, and one or more defined indications. An application is a request for FDA to approve a product. An indication is the approved use for a defined group of people. Approval does not extend to every vial, tablet, implant, compounded preparation, or research product that uses the same ingredient word.

The same active ingredient can appear in products with different brand names, routes, applications, and uses. Semaglutide alone appears in separate approved applications for injection and tablets, with labeling that differs by product. Tirzepatide injection appears in distinct applications: Mounjaro for type 2 diabetes, and Zepbound for chronic weight management and obstructive sleep apnea. The molecule name alone does not identify which approval a claim refers to.

The directory below is a bounded, non-exhaustive set of U.S. products. The directory records were checked on August 30, 2026. The Mounjaro entry was updated on October 12, 2026. The list orients readers to official records. It does not recommend treatment, rank safety, guide prescribing, or say that a product suits a particular person.

What counts as a peptide medicine in the directory.

The directory is a selected list and does not cover every approved peptide-related medicine. The word peptide can describe short amino-acid chains, modified peptide analogues, peptide hormones, and peptide-containing radiopharmaceuticals.

The regulatory pathway does not draw a clean scientific boundary. Many products are approved through New Drug Applications (NDAs). Some peptide or protein products use Biologics License Applications (BLAs). Egrifta SV, for example, appears in the Purple Book under BLA 022505.

The directory includes selected medicines whose active component FDA labeling or review material describes as a peptide, peptide analogue, peptide hormone, or radiolabeled peptide analogue. It excludes therapeutic proteins and insulin products, generic duplicates, every strength and presentation, discontinued historical products, diagnostic agents, and most hospital-only peptide products.

A product left out may still be approved. It sits outside this edition's deliberately limited scope.

Every entry names the exact brand, ingredient, application, dosage form, route, and a plain-language summary of the labeled use. A route is how a product enters the body. Use the current FDA application record and approved labeling for the current status, indications, and limitations. Marketing status, warnings, presentations, and indications can change after this review date.

Weight, diabetes, heart, and kidney uses.

• Wegovy (semaglutide) injection, NDA 215256, is an injection solution given by the subcutaneous route. Its current label covers long-term weight reduction and maintenance in specified adult and pediatric populations, and cardiovascular-event risk reduction in specified adults. It also has an injection-specific indication for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis.
• Wegovy (semaglutide) tablets, NDA 218316, are tablets taken by the oral route. FDA's December 22, 2025 approval letter covers long-term weight reduction and maintenance in specified adults and major cardiovascular-event risk reduction in specified adults. The tablet application is separate from the injection application.
• Ozempic (semaglutide) injection, NDA 209637, is an injection solution given by the subcutaneous route. Its current label covers glycemic control in adults with type 2 diabetes and major cardiovascular-event risk reduction in specified adults. It also covers reduction of specified kidney and cardiovascular outcomes in adults with type 2 diabetes and chronic kidney disease. Ozempic has its own application, separate from Wegovy.
• Rybelsus and Ozempic tablets (semaglutide), NDA 213051, are tablets taken by the oral route. Their current shared label covers glycemic control in adults with type 2 diabetes. It also covers major cardiovascular-event risk reduction in adults with type 2 diabetes who are at high risk. An oral brand name does not inherit the injection product's entire label.
• Mounjaro (tirzepatide), NDA 215866, is an injection solution given under the skin (the subcutaneous route). Its August 2026 label covers blood-sugar control in adults and children age 10 or older with type 2 diabetes. It also covers lower risk of cardiovascular death, nonfatal heart attack, and nonfatal stroke in high-risk adults with type 2 diabetes. Cardiovascular death means death from heart or blood-vessel disease. These uses apply to Mounjaro; Zepbound has a separate label.
• Zepbound (tirzepatide), NDA 217806, is an injection solution given by the subcutaneous route. Its current label covers long-term weight reduction and maintenance in specified adults. It also covers treatment of moderate-to-severe obstructive sleep apnea in adults with obesity. Mounjaro's diabetes indication and Zepbound's indications are separate approval claims.

Bone health, severe low blood sugar, and HIV-related fat changes.

Approved peptide medicines extend well beyond weight loss. A broad goal such as “bone,” “metabolism,” or “fat loss” does not identify an approved use for these products either.

• Forteo (teriparatide), NDA 021318, is a solution in a prefilled delivery device given by the subcutaneous route. Its current label covers defined osteoporosis populations at high fracture risk. They include certain postmenopausal women, men with primary or hypogonadal osteoporosis, and people with osteoporosis associated with sustained systemic glucocorticoid therapy.
• Baqsimi (glucagon), NDA 210134, is a single-dose nasal powder given by the intranasal route. Its current label covers treatment of severe hypoglycemia in adults and pediatric patients one year and older with diabetes. That emergency-rescue indication makes no general metabolic-health claim.
• Egrifta SV (tesamorelin), BLA 022505, is a licensed biological product. It is supplied as lyophilized powder for subcutaneous injection after preparation. Its current label covers reduction of excess abdominal fat in adults with HIV and lipodystrophy. The label specifically says it is not indicated for weight-loss management and describes it as weight neutral.

Sexual health and rare light-sensitivity uses.

Melanocortin-related products share receptor biology, which can invite broad claims. The approvals themselves are narrow and product-specific.

• Vyleesi (bremelanotide), NDA 210557, is a solution in a single-dose autoinjector given by the subcutaneous route. Its current label covers acquired, generalized hypoactive sexual desire disorder in premenopausal women when the label's defining conditions are met. It is not indicated for men, postmenopausal women, or enhancement of sexual performance.
• Scenesse (afamelanotide), NDA 210797, is a 16 mg bioresorbable implant placed subcutaneously. Its current label covers increasing pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. That rare-disease approval does not establish tanning, cosmetic pigmentation, or the safety of other melanocortin products.

Severe pain, critical care, tumors, and acromegaly.

Several peptide medicines are used in highly supervised settings. Their routes and indications state that clinical context directly, and their listing here makes no comparison with wellness products.

• Prialt (ziconotide), NDA 021060, is a solution for intrathecal infusion. Its current label covers severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to specified other treatments. Intrathecal administration is not interchangeable with an injection under the skin.
• Giapreza (angiotensin II), NDA 209360, is a solution for intravenous infusion after dilution. Its current label covers increasing blood pressure in adults with septic or other distributive shock.
• Vasostrict (vasopressin), NDA 204485, is an injection solution given by the intravenous route, including forms requiring dilution and premixed presentations. Its current label covers increasing blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
• Lutathera (lutetium Lu 177 dotatate), NDA 208700, is a radiolabeled somatostatin-analogue solution given by the intravenous route. Its current label covers somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors in adults and pediatric patients 12 years and older.
• Mycapssa (octreotide), NDA 208232, is a delayed-release capsule taken by the oral route. Its current label covers long-term maintenance treatment in people with acromegaly who have responded to and tolerated octreotide or lanreotide. Mycapssa does not make other octreotide formulations interchangeable with it.

Approval does not apply to every molecule, route, or goal.

Check an approval statement by changing one field at a time. If the brand, application number, dosage form, route, population, or indication changes, the original statement may no longer be true. Wegovy tablets and Wegovy injection have separate NDAs.

Ozempic injection and oral semaglutide products do not share every use. Mounjaro and Zepbound both contain tirzepatide and have distinct applications and labels.

The same rule applies beyond metabolic products. Egrifta SV's HIV-lipodystrophy indication does not extend to general weight management. Scenesse's EPP indication does not extend to cosmetic tanning.

Vyleesi's defined HSDD indication does not extend to sexual performance. A provider or seller should be able to name the exact marketed product and show the claim in that product's current label.

FDA approval also does not mean risk-free, suitable for everyone, superior to alternatives, or approved for every use a clinician might lawfully consider. The directory answers a regulatory identity question. Decisions about benefit and risk rest on the label, the patient's clinical context, and a qualified prescriber.

Compounded and research-labeled products do not get that approval.

FDA states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness, or quality before marketing. Compounding can serve a legitimate patient-specific need under applicable law. A compounded preparation is still a different product from the branded product named in an NDA or BLA. A matching ingredient word on an invoice or vial does not show the same formulation, manufacturing controls, stability, delivery system, or label.

A “research use only” label does not establish an approved drug product. An online vial labeled semaglutide, tirzepatide, tesamorelin, bremelanotide, afamelanotide, or another peptide does not become an approved medicine because an approved product contains a related active ingredient. FDA has separately warned about unapproved GLP-1 products and salt forms that differ from the active ingredients in approved products. It has also warned about dosing errors, fraudulent labeling, and counterfeit supply.

The approval check is product-specific. It names the brand, the applicant and application, the dosage form and route, and the labeled indication. If those answers do not point to the same FDA record, the approval claim has not been established. Authenticity and lawful supply are separate checks, because an approval record alone cannot prove that a package in hand is genuine.

How to check an approval and how the directory stays current.

Start with Drugs@FDA for NDA and ANDA products and the Purple Book for licensed biological products. Search the proprietary name and active ingredient, then open the application record and latest label. Confirm the application number, applicant, dosage form, route, marketing status, indications and limitations, and label revision date.

FDA notes that Drugs@FDA is updated daily. It is a stronger record than a clinic page, seller page, search snippet, or undated list.

A claim that a product is not approved needs more than one search. Check name variants, the exact active ingredient, both Drugs@FDA and the Purple Book, and FDA enforcement or compounding materials. The directory makes no claim to catalog every approved or unapproved peptide. It reports the bounded records actually audited.

The directory follows the site's published review cadence. A material FDA approval, withdrawal, safety communication, or label expansion triggers an immediate re-review. Each revision must preserve the application-level audit trail and review date. An entry that cannot be matched to a current official record will be marked cannot confirm or removed until the conflict is resolved.