A Short List of Peptides That Are Actually FDA-Approved Drugs. And a Much Longer List of Ones People Assume Are.
A handful of peptide drugs have gone through full clinical trials and FDA review, each for a specific, narrow, labeled use. Most of what’s marketed as “peptides” online isn’t on that list, no matter how confidently a product page implies otherwise.
Reviewed by the PepGuard team · Last reviewed Jul 28, 2026
- Tesamorelin (Egrifta), bremelanotide (Vyleesi), and elamipretide (Forzinity) are approved peptide drugs, each for one narrow indication.
- Semaglutide, liraglutide, and tirzepatide, the GLP-1-class drugs, are approved peptide drugs too, under brand names like Ozempic, Wegovy, Saxenda, Mounjaro, and Zepbound.
- BPC-157, TB-500, retatrutide, and cagrilintide are NOT FDA-approved, despite heavy online marketing implying otherwise.
- A planned FDA filing, or even a submitted one, is not the same thing as an approval.
Photo: David Trinks / UnsplashThe actual approved list.
| Peptide | Brand name | Approved for | First approved |
|---|---|---|---|
| Tesamorelin | Egrifta | HIV-associated lipodystrophy | 2010 |
| Bremelanotide | Vyleesi | Hypoactive sexual desire disorder (women) | 2019 |
| Elamipretide (SS-31) | Forzinity | Barth syndrome (accelerated approval) | 2025 |
| Liraglutide | Victoza / Saxenda | Type 2 diabetes / chronic weight management | 2010 / 2014 |
| Semaglutide | Ozempic / Rybelsus / Wegovy | Type 2 diabetes / chronic weight management | 2017 / 2019 / 2021 |
| Tirzepatide | Mounjaro / Zepbound | Type 2 diabetes / chronic weight management | 2022 / 2023 |
Every one of these is approved for a specific labeled indication, at a specific dose, as a specific manufactured product. See PepGuard’s own evidence reports for Tesamorelin, bremelanotide (PT-141), and elamipretide (SS-31) for the full trial history behind each approval.
Commonly assumed approved, and aren’t.
BPC-157 and TB-500 have never been approved by the FDA for any use, and neither is a component of any approved drug.
Retatrutide has completed four positive Phase 3 trials, and Eli Lilly has stated a plan to file for FDA approval in the first quarter of 2027. A plan to file is not a filing, and a filing is not an approval, none of those steps has happened yet.
Cagrilintide is further along than most, but not the way vendors imply. Novo Nordisk did file an actual FDA application in December 2025, with a decision anticipated by late 2026, but that filing was for CagriSema, the fixed-dose combination of cagrilintide with semaglutide. There is no filing for cagrilintide as a standalone product, and in its own head-to-head Phase 3 comparator arm, cagrilintide alone underperformed semaglutide alone.
See the full evidence reports for BPC-157, TB-500, retatrutide, and cagrilintide for the trial data and regulatory timeline behind each.
Why the confusion happens.
One documented case shows the pattern directly: an FDA warning letter cited a vendor for advertising a “40.4% versus 16.2%” weight-loss comparison on its standalone-cagrilintide product page. Those numbers were real, they just described CagriSema, the combination drug, not the cagrilintide-only product actually being sold on that page. Real trial data, attached to the wrong product, is a documented, recurring pattern, not an isolated mistake.
Every approval date above, traced back.
Original FDA approval letters and Drugs@FDA records for every product in the roster table. Click through and check them yourself.
FDA-approval questions, answered.
No. BPC-157 has never been approved by the FDA for any use, and it isn't a component of any approved drug. See PepGuard's BPC-157 evidence report for its actual regulatory and trial status.
Semaglutide (Wegovy, approved June 2021, and the original Ozempic injection, approved December 2017, for type 2 diabetes) and tirzepatide (Zepbound, approved November 2023, and Mounjaro, approved May 2022, for type 2 diabetes) are both FDA-approved GLP-1-class peptide drugs. Liraglutide (Saxenda, approved December 2014) was the first GLP-1 approved specifically for chronic weight management.
Yes. Semaglutide is a 31-amino-acid peptide analog of human GLP-1, chemically modified to resist rapid breakdown so it can be dosed weekly instead of daily. It's the same broad molecular class as most of the compounds covered on this site, it's simply gone through full FDA approval under brand names like Ozempic and Wegovy, with a prescription and a manufactured, regulated supply chain behind it.
Both are further along than most unapproved peptides, but neither is approved today. Eli Lilly has completed four positive Phase 3 trials for retatrutide and stated a plan to file for FDA approval in Q1 2027, a plan is not a submission. Novo Nordisk filed an actual FDA application for CagriSema (cagrilintide combined with semaglutide) in December 2025, with a decision anticipated by late 2026, but that filing is for the combination product, not for cagrilintide alone. See each peptide's own evidence report for the full timeline.
An approved drug like Wegovy went through full clinical trials, a formal FDA review, and is manufactured under regulated conditions with a specific label. A compounded product is prepared under a narrower legal exemption (503A or 503B) that never requires the same trial evidence, and only applies to substances that clear a specific eligibility test. Most peptides marketed as "research chemicals" online meet neither standard.
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