FDA-Approved Peptides: A List of Peptide Medicines From Drugs@FDA

What “FDA-approved” means for a peptide

FDA approves products, not molecules. An approval belongs to one applicant’s product, made to one specification, for the uses written on its label. Drugs@FDA, the agency’s public database, lists each application, its approval history and whether each product is still marketed. A peptide “is FDA-approved” in the loose sense that at least one product containing it has an approval; a different product with the same peptide does not share it.

FDA has no “peptide” category, so lists of approved peptides differ in where they stop. This one includes a substance when its U.S. label calls it a peptide, polypeptide or an analogue of a peptide hormone. It leaves out larger proteins such as somatropin and antibodies, but keeps insulin, which the peptide hormones page also treats as a peptide hormone.

Metabolic and gut hormones

Insulin, glucagon, the incretin medicines and other gut-hormone analogues.

Blood, heart and immune system

Anticoagulants, a platelet inhibitor, complement inhibitors and others.

Nerves, skin, gut and diagnostics

A cone-snail toxin, two melanocortin peptides, gut peptides, a radiolabelled peptide and a diagnostic peptide.

How to read the dates

Each year is the earliest original approval Drugs@FDA records for the substance across its brand-name and other new drug applications, generics excluded. For older medicines the database can start later than the medicine’s first U.S. use, so read the year as “approved by”, not “first approved in”. A few rows carry a biologics licence (BLA) rather than a drug application (NDA): since March 2020, U.S. rules treat a chain of more than 40 amino acids as a protein, which our peptide vs protein page explains. Brand names are given to identify the product; some brands, such as Symlin, are now listed as discontinued.

Sources: Drugs@FDA via openFDA, original approvals by application (for example NDA209637 semaglutide, 5 December 2017; NDA215866 tirzepatide, 13 May 2022; BLA022505 tesamorelin, 10 November 2010; NDA215244 elamipretide, 19 September 2025); the DESCRIPTION section of each product’s current U.S. label via openFDA. Read 2 November 2026.

How the peptides sold for research compare

Our guide library covers 55 compounds and records each one’s FDA position with a date. As of those records (October 2026), 7 have an approved product on the market (semaglutide, tirzepatide, tesamorelin, oxytocin, PT-141, SS-31 and melanotan 1 as afamelanotide), 2 were approved once and are now listed as discontinued (sermorelin and gonadorelin), and 46 have no approved medicine at all, among them BPC-157, TB-500, ipamorelin, CJC-1295, GHK-Cu, epitalon, MOTS-c, KPV, semax and selank. Even where an approved medicine exists, a product sold for research use only is not that medicine and is labelled not for human use. Whether a compound may be compounded by a pharmacy is a separate question, set out in our peptide legality page and in what research peptides are.

Medibact does not manufacture or sell peptides. We supply USP-grade bacteriostatic water, made in the USA, for research use only, and publish reference material like this page.

Where this sits in the rest of the reference

FAQ

References: Drugs@FDA (openFDA drugsfda endpoint), original approvals for the 47 substances listed; current U.S. labels via openFDA (DESCRIPTION sections); this site’s compound-guide regulatory records (US cells, October 2026). Read 2 November 2026.