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FDA-Approved Peptides

35 peptides on this site have an FDA approval in the US, and 13 more are approved only in other countries. At each maker's request, FDA withdrew the approvals of enfuvirtide (Fuzeon), nesiritide (Natrecor) and sermorelin (Geref), so their cards are marked. Filter by goal, see what the research and users say about each one, and open any card for the full profile.

35 approved in the US13 approved outside the US onlyFDA records from

Peptide Schedule Research TeamReviewed Oct 10, 2026

Which Peptides Are FDA-Approved?

Filter by goal, region or whether a product is still sold. Each card links to the full profile.

Approved in
Goal
Status

Showing 38 peptides, including 3 whose FDA approval was withdrawn

Which Peptides Are Approved Only Outside the US?

13 peptides on this site have an approval from another country's regulator but none from the FDA. Approvals abroad only inside a combination product, such as VIP in Invicorp, are not counted.

  • Atosiban (Tractocile): EU approved (Tractocile, 2000) to delay preterm labor.
  • Carbetocin (Duratocin/Pabal): Approved in Canada (1997), the EU and many other countries to prevent bleeding after childbirth.
  • Cerebrolysin: Authorized in Austria, Russia and other countries, not in the US.
  • Cortexin: Registered in Russia (Geropharm) for stroke and brain injury.
  • DSIP: Registered in Russia as Deltaran nasal spray for stress and alcohol withdrawal.
  • GHRP-2: Approved in Japan (2004) only as a one-dose diagnostic test for growth hormone deficiency, not as a treatment.
  • Glutathione: Approved in Japan as Tathion injection for drug poisoning, liver disease and skin pigmentation.
  • Mazdutide: Approved in China (June 2025) for weight management.
  • Selank: Registered in Russia since 2009 as 0.15% nasal drops for anxiety.
  • Semax: Registered in Russia as 0.1% nasal drops for stroke recovery and cognitive problems (renewed 2025).
  • Somatostatin (SST-14 and SST-28): Native somatostatin infusion is approved in Spain, Belgium, Germany and Italy for GI bleeding and pancreatic surgery.
  • Thymalin: Registered in Russia (Samson-Med) as an immune drug.
  • Thymosin Alpha 1: Approved in China (Zadaxin, 1996) and about 30 other countries.

How This List Is Built

US approvals come from FDA's Drugs@FDA records and, for biologics, FDA's Purple Book. Every application number and FDA record is in the peptide regulatory tracker. Non-US approvals come from the peptide evidence gap study, checked against each country's regulator.

The list follows this site's catalog, which includes some protein hormones and fusion proteins that FDA licenses as biologics (BLAs).

Drugs@FDA calls a product "Discontinued" both when it is still approved but no longer sold and when FDA has withdrawn its approval. Withdrawals come from the Federal Register: enfuvirtide (Fuzeon; 91 FR 41045, effective ), nesiritide (Natrecor; 85 FR 28950, effective ) and sermorelin (Geref; 74 FR 23407, effective ). In each case the maker asked FDA to withdraw the approval because the product was no longer sold. They stay on this list, marked, and are not counted as approved.

"Research says" and "Users say" come from each peptide's own summary of published studies and community reports: the opening lines, plus any key caveat. User reports are not trials. Open a card for the sources, doses, side effects and the full picture.

FDA-approved but not peptides, so not listed: TRT (Testosterone Replacement Therapy), L-Carnitine, Orforglipron. Approved outside the US but not peptides: Bromantane (Ladasten), NAD+, Omberacetam (Noopept). Approval means a regulator cleared a specific product for a specific use. It is not a reason to use any peptide, and this page is not medical advice.