Which Peptides Are FDA Approved?
7 of the 36 compounds we track have an FDA-approved product in the United States. 2 more are not approved but can be lawfully compounded by a US pharmacy. The remaining 27 are neither — whatever a seller’s label says.
Fact-checking at PeptideProbe is editorial, not clinical. Our editors check claims, dosing figures, and trial results against primary sources; they are not licensed clinicians and do not provide medical review. Nothing here is medical advice — talk to a qualified healthcare provider before starting any therapy.
Educational tool — not medical advice. This calculator provides estimates based on population averages and published trial data. Outputs are not clinical recommendations and do not replace evaluation by a qualified prescriber. Do not start, stop, or change a peptide therapy based on the result of this tool.
FDA-approved (7)
An FDA-approved drug product containing this molecule exists in the United States today. Approval is for a specific indication — it does not mean every use a clinic advertises has been reviewed.
- LiraglutideStatus from FDA approval record
- OrforglipronStatus from FDA approval record
- PT-141Status from FDA approval record
- SS-31 (Elamipretide)Status from FDA approval record
- SemaglutideStatus from FDA approval record
- TesamorelinStatus from FDA approval record
- TirzepatideStatus from FDA approval record
Not approved, but legitimately compounded (2)
No FDA-approved product exists, but US compounding pharmacies may lawfully prepare it. Compounded drugs are not FDA-approved, and are not reviewed for safety, effectiveness or manufacturing quality before they reach a patient.
- GonadorelinStatus from FDA approval record
- SermorelinStatus from FDA approval record
Neither approved nor lawfully compounded (27)
No approved US product and no established route to lawful compounding. Sellers commonly label these “for research use only”. That phrase is a seller's disclaimer, not an authorization to administer anything to a person — FDA has issued warning letters over exactly that framing.
- 5-Amino-1MQStatus from FDA approval record
- AOD-9604Status from FDA approval record
- BPC-157Full regulatory detail →
- CJC-1295Status from FDA approval record
- CagriSemaStatus from FDA approval record
- CagrilintideStatus from FDA approval record
- DSIPStatus from FDA approval record
- DihexaStatus from FDA approval record
- EpithalonFull regulatory detail →
- GHK-CuStatus from FDA approval record
- GHRP-2Status from FDA approval record
- GHRP-6Status from FDA approval record
- HexarelinStatus from FDA approval record
- IGF-1 LR3Status from FDA approval record
- IpamorelinStatus from FDA approval record
- KPVFull regulatory detail →
- LL-37Status from FDA approval record
- MOTS-cFull regulatory detail →
- MazdutideStatus from FDA approval record
- NAD+Status from FDA approval record
- RetatrutideFull regulatory detail →
- SelankStatus from FDA approval record
- SemaxStatus from FDA approval record
- SurvodutideStatus from FDA approval record
- TB-500Full regulatory detail →
- TesofensineStatus from FDA approval record
- Thymosin Alpha-1Status from FDA approval record
What has changed
Every entry below is a change to what the federal record says, dated to when it took effect rather than when we noticed it. Each links to the primary source.
Eli Lilly's pre-approval expanded access programme for retatrutide was listed as AVAILABLE for individual patients — the first lawful route to the drug outside a clinical trial.
ClinicalTrials.gov NCT07629401PCAC voted 6-7 against recommending Emideltide (DSIP) for the 503A Bulks List.
FDA PCAC meeting, July 23-24, 2026PCAC voted 7-5 to recommend Epitalon for the 503A Bulks List. Advisory only — FDA must still complete rulemaking before 21 CFR 216.23 changes.
FDA PCAC meeting, July 23-24, 2026PCAC voted 8-5 to recommend Semax for the 503A Bulks List. Advisory only — FDA must still complete rulemaking before 21 CFR 216.23 changes.
FDA PCAC meeting, July 23-24, 2026PCAC voted 7-5 to recommend MOTS-c for the 503A Bulks List. Advisory only — FDA must still complete rulemaking before 21 CFR 216.23 changes.
FDA PCAC meeting, July 23-24, 2026PCAC voted 8-6 to recommend TB-500 for the 503A Bulks List. Advisory only — FDA must still complete rulemaking before 21 CFR 216.23 changes.
FDA PCAC meeting, July 23-24, 2026PCAC voted 8-6 to recommend KPV for the 503A Bulks List. Advisory only — FDA must still complete rulemaking before 21 CFR 216.23 changes.
FDA PCAC meeting, July 23-24, 2026PCAC voted 8-6 to recommend BPC-157 for the 503A Bulks List. Advisory only — FDA must still complete rulemaking before 21 CFR 216.23 changes.
FDA PCAC meeting, July 23-24, 2026FDA issued a warning letter treating retatrutide and tirzepatide products sold under “research use only” labelling as unapproved new drugs under section 505(a).
FDA warning letter, Gram Peptides
The 503A compounding tracker
The 8 substances with a full regulatory record are the ones the Pharmacy Compounding Advisory Committee considered on July 23-24, 2026. The tracker shows what FDA’s own reviewers said, the indication actually evaluated, and the rulemaking that must still happen before anything changes.
Open the 503A trackerCommon questions
Which peptides are FDA approved?
7 of the 36 compounds we track have an FDA-approved product in the United States: Liraglutide, Orforglipron, PT-141, SS-31 (Elamipretide), Semaglutide, Tesamorelin, Tirzepatide. Approval is always for a specific indication, so an approved molecule can still be prescribed off-label for uses FDA never reviewed.
Does “research use only” mean a peptide is legal to take?
No. “Research use only” is a label a seller applies to their own product. It is not an FDA designation and it does not authorize administering anything to a person. FDA has issued warning letters to sellers using that framing on compounds including retatrutide and tirzepatide, treating the products as unapproved new drugs.
Did the July 2026 FDA advisory vote make these peptides legal?
No. The Pharmacy Compounding Advisory Committee met July 23-24, 2026 and voted on whether to recommend certain substances for the 503A Bulks List. That vote is advisory. FDA must still complete notice-and-comment rulemaking before the list at 21 CFR 216.23 changes, and nothing about what a pharmacy may lawfully compound changed on the day of the vote.
How current is this page?
Every entry was last checked against its primary sources on 2026-08-29. Changes are logged with the date they took effect and a link to the source, and the page is updated in place rather than republished as a new article.
Statuses reflect the United States only and were last checked against primary sources on 2026-08-29. Regulatory status changes; the date above is when a person last verified it, not when this page was rebuilt. Detailed entries carry their own review dates and sources. Earlier entries were compiled as of 2026-07-28.
Medical Disclaimer: This content is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare provider before beginning any peptide therapy treatment.