Regulatory · FDAresearch use only
FRegulatory · FDA
FDA-approved peptides
Five compounds in this library hold a current FDA approval. One more holds approvals outside the United States. Everything else is investigational, research-only, or unapproved.
| Compound | Approval covers | Date | Profile |
|---|---|---|---|
| Semaglutide | Type 2 diabetes; chronic weight management | First approval 2017 | Open → |
| Tirzepatide | Type 2 diabetes; obesity and obstructive sleep apnea | 13 May 2022 | Open → |
| Tesamorelin | Excess abdominal fat in adults with HIV and lipodystrophy | Egrifta WR sBLA, 25 March 2025 | Open → |
| Afamelanotide (Melanotan I) | Erythropoietic protoporphyria | 8 October 2019 | Open → |
| Elamipretide (SS-31) | Barth syndrome, muscle strength | 19 September 2025, accelerated | Open → |
| Thymosin Alpha-1 not FDA | Approved in 35+ countries, not by the FDA | Launched in the 1990s | Open → |
Read the scope, not just the name.
Every approval above covers a specific indication. Tesamorelin is approved for one HIV-related indication and is weight-neutral. Elamipretide is approved for one rare disease. An approval for one indication is not evidence for another.
Sermorelin is a special case.
It held an FDA approval as a diagnostic agent from 1997. The approval ended in 2008 for commercial reasons, not because of a safety finding. Read the Sermorelin profile.