FDA-Approved Peptides: The Full List, Read From Drugs@FDA, With What Is Still on the Market

FDA does not publish a list of approved peptides. Its approvals database, Drugs@FDA, lists drugs by product and application, not by chemical class, so "which peptides are approved" has no official answer. This page builds one, states exactly how, and keeps the result reproducible.

What it means for a compound to be approved, compounded or sold as research material is explained on our peptide therapy page, and what "research use only" does and does not mean is on our research-use-only page.

How this list was built

What counts as a peptide here. FDA's own line: under 21 CFR 600.3(h)(6), a protein is "any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size." So a peptide, for this census, is a defined chain of 40 amino acids or fewer. That matters because on 23 March 2020 FDA moved approved proteins from drug applications to biologics licences, and its transition notice states the change "does not affect 'peptides' (i.e., polymers composed of 40 or fewer amino acids)."

What is left out, and why. Insulin and other proteins (over 40 amino acids). Antibiotics and immunosuppressants built from amino acids, such as vancomycin, daptomycin and cyclosporine, which nobody asks about as "peptides". Small modified di- and tripeptide molecules such as bortezomib. These are editorial choices; a different boundary gives a different count, which is why published totals disagree.

Where the data came from. Each product was looked up by brand and by active ingredient in Drugs@FDA through openFDA's drugsfda endpoint (data last updated 2026-10-02), read on 2026-10-06. The date given is the earliest approval among the applications listed for that ingredient's reference brand — not always the first approval of the molecule anywhere. "Marketed" means at least one product under that ingredient is listed with a prescription marketing status; "discontinued" means none is.

The census: 43 approved peptide active ingredients

Vasopressin's date is that of Vasostrict, the brand application listed today; the hormone itself was in medical use long before 2014, and the same is true of oxytocin and glucagon.

Counted: 43 ingredients · 37 with a marketed product · 6 with none.

What "discontinued" does and does not mean

A discontinued listing means no product under that application is being marketed. It is not a safety finding. For sermorelin, FDA's database carries a note that GEREF "was not discontinued or withdrawn for safety or effectiveness reasons" — a determination that, under the compounding rules, allows a pharmacy to compound it now. That is the whole reason a drug with no marketed product appears on clinic menus. The full sermorelin record is on our sermorelin dosage page, and what its trials measured is on our sermorelin results page.

The edge cases readers ask about

The popular names that are not approved

None of these has an approved application in Drugs@FDA. Each is named on FDA's page of bulk drug substances that may present significant safety risks in compounding (content current as of 2026-04-22), usually for possible immunogenicity, peptide-related impurities and little or no human safety information.

In July 2026 FDA's Pharmacy Compounding Advisory Committee reviewed seven of these. FDA's staff advised against all seven; the committee voted for six and against DSIP. A vote is advice, not an approval, and does not create an approved product either way. The detail, with sources, is on our peptide therapy page and our 503A category 2 page.

What this list does not show

• Approvals outside the US. Thymosin alpha-1, cerebrolysin, semax and selank are registered in other countries; this census is FDA only.
• Every generic. Most marketed ingredients here also have generic applications; the table names reference brands.
• Whether a compounded or research-market product contains what its label says. An approval covers the approved product made under its application, nothing else. How that is checked is on our peptide testing page.
• Safety. Approval means FDA found benefits outweighed risks for a labelled use. What that leaves open is on our are peptides safe page.

GLP-1 drugs appear above as census rows only; their dosing, side effects and safety record are covered by GLP1 Ledger. Beginners' explanations of most molecules here are in Peptide Lexicon's compound index.

Sources and dates

• Drugs@FDA via openFDA drugsfda endpoint, queried by brand name and active ingredient on 2026-10-06; dataset last_updated 2026-10-02. Kind of source: regulator database (tier 1).
• 21 CFR 600.3(h)(6), eCFR, read 2026-10-06.
• FDA, "Deemed to be a License" Provision of the BPCI Act, read 2026-10-06.
• FDA, Certain bulk drug substances for use in compounding that may present significant safety risks, content current as of 2026-04-22, read 2026-10-06.