Peptide FDA Approval Tracker
A sourced, point-in-time map of where every major peptide stands with the FDA — approved drug, clinical-trial candidate, or research chemical — plus the compounding rules that keep changing.
How It Works
A prescription drug the FDA has reviewed and cleared for a specific use. Has an application number in Drugs@FDA. Example: semaglutide (Wegovy).
Under active study in registered human trials but not yet approved. Not legally available by prescription. Example: retatrutide (Phase 3).
Sold "for research use only," with no FDA approval and no active drug-approval pathway for the marketed use. Example: most SARMs, MK-677.
Not approved, and specifically flagged by the FDA (503A Category 2) as unsuitable for pharmacy compounding on safety grounds. Example: BPC-157.
What the Data Shows
Peptide FDA Approval Status
FDA-approved drugs vs. compounds still in trials vs. research chemicals — with the source for every status.
| Compound | Status | Indication / Note | Source |
|---|---|---|---|
| Semaglutide Ozempic · Wegovy · Rybelsus |
✅ Approved | Type 2 diabetes & chronic weight management | FDA NDA 213051 / 215256 / 209637 — Novo Nordisk |
| Tirzepatide Mounjaro · Zepbound |
✅ Approved | Type 2 diabetes & obesity | FDA NDA 215866 / 217806 — Eli Lilly |
| Liraglutide Victoza · Saxenda |
✅ Approved | Type 2 diabetes & obesity (generics now available) | FDA ANDA 215503 + originator NDAs |
| Dulaglutide Trulicity |
✅ Approved | Type 2 diabetes | FDA BLA 125469 — Eli Lilly |
| Exenatide Byetta · Bydureon |
✅ Approved | Type 2 diabetes | FDA NDA 021773 / 021919 |
| Bremelanotide PT-141 · Vyleesi |
✅ Approved | Hypoactive sexual desire disorder (women) | FDA NDA 210557 |
| Setmelanotide Imcivree |
✅ Approved | Rare genetic (MC4R-pathway) obesity | FDA NDA 213793 — Rhythm |
| Tesamorelin Egrifta |
✅ Approved | HIV-associated lipodystrophy | FDA BLA 022505 — Theratechnologies |
| Retatrutide LY3437943 · "triple-G" |
🔬 Phase 3 | Obesity / metabolic (Lilly TRIUMPH program) | ClinicalTrials.gov NCT06297603 — not yet approved |
| Orforglipron LY3502970 (oral GLP-1) |
🔬 Phase 3 | Obesity & type 2 diabetes | ClinicalTrials.gov NCT05869903 — Eli Lilly |
| Survodutide BI 456906 |
🔬 Phase 3 | Obesity & MASH | ClinicalTrials.gov NCT06309992 — Boehringer / Zealand |
| Cagrilintide part of CagriSema |
🔬 Phase 3 | Obesity (paired with semaglutide) | ClinicalTrials.gov NCT07220759 — Novo Nordisk |
| Mazdutide IBI362 · LY3305677 |
🔬 Phase 3 | Obesity (approved in China 2025; not FDA-approved) | ClinicalTrials.gov NCT07469800 — Innovent |
| BPC-157 Body Protection Compound-157 |
⚠️ Restricted | Not approved. FDA 503A Category 2 (safety-risk) — bars pharmacy compounding | FDA 503A bulk-substance review 2023; early trial NCT07437547 (Phase 2) |
| Thymosin beta-4 TB-500 |
⚠️ Restricted | Not approved. Named in FDA 503A Category 2 compounding review | FDA 503A bulk-substance review |
| CJC-1295 / Ipamorelin GH secretagogues |
⚗️ Research chem | Not approved. Common in compounding-crackdown warning letters | No FDA approval on record |
| MK-677 Ibutamoren |
⚗️ Research chem | Investigational GH secretagogue — never FDA approved | No FDA approval on record |
| SARMs Ostarine · RAD-140 · LGD-4033 … |
⚗️ Research chem | None FDA approved; FDA has issued public warnings | FDA warning letters / public advisories |
| Melanotan II MT-II |
⚗️ Research chem | Not approved; FDA has warned against sale | No FDA approval on record |
| Epitalon Epithalon |
⚗️ Research chem | Not approved anywhere as a drug | No FDA approval on record |
Sources: FDA Drugs@FDA (drugsfda) application records and U.S. National Library of Medicine ClinicalTrials.gov, verified July 8, 2026. "Research chemical" = sold for laboratory research only, not an approved or FDA-pipeline drug for the listed use.
The Compounding & Policy Timeline
Why "you could get it last year" doesn't mean "you can get it legally today." The rules around compounded peptides have moved repeatedly.
Vyleesi (2019), Imcivree (2020), Wegovy (2021), Mounjaro (2022) and Zepbound (2023) bring GLP-1 / melanocortin drugs into the mainstream. A parallel gray market of compounded and "research" peptides grows alongside.
In its review of bulk drug substances for pharmacy compounding, the FDA placed several popular peptides — including BPC-157 — in Category 2, citing significant safety-data gaps. Practical effect: 503A compounding pharmacies are directed to stop using them.
The FDA resolved the tirzepatide shortage (late 2024) and the semaglutide shortage (Feb 2025). Because large-scale compounding of these drugs was legal only during an official shortage, that basis disappeared — and 2025 enforcement wind-down deadlines followed for compounders and outsourcing facilities.
Robert F. Kennedy Jr. was confirmed as HHS Secretary in February 2025, and the "Make America Healthy Again" posture has signaled interest in wellness and longevity medicine. As of , that hasn't translated into a formal rescheduling or a new approval pathway for research peptides — and litigation over compounded GLP-1s continues. Treat any "it's about to be legal" claim as speculation until an official FDA action confirms it.
Key Takeaways
- Eight peptide drugs on this list are fully FDA-approved, each with a verifiable Drugs@FDA application number — the GLP-1s (semaglutide, tirzepatide, liraglutide, dulaglutide, exenatide) plus bremelanotide, setmelanotide, and tesamorelin.
- The most-hyped weight-loss peptides that are NOT yet approved — retatrutide, orforglipron, survodutide, cagrilintide, mazdutide — are in Phase 3 trials, with real ClinicalTrials.gov registrations.
- BPC-157 is not FDA-approved and was placed in the FDA 503A Category 2 review, which restricts pharmacy compounding of it on safety grounds.
- Compounded semaglutide and tirzepatide lost their main legal basis when the FDA declared those shortages resolved (2024–25); enforcement deadlines followed.
- SARMs, MK-677, melanotan II, and CJC-1295/ipamorelin have no FDA approval for the uses they are marketed for.
- Whether the current HHS leadership will change any peptide's legal status — as of the update date, no formal rescheduling or new approval pathway for research peptides has been enacted.
- Exact, current enforcement dates and state-by-state pharmacy-board interpretation of the compounding rules, which continue to shift and are subject to ongoing litigation.
- Whether Phase 3 trial peptides (retatrutide, orforglipron, etc.) will ultimately be approved, and for which indications — trials can still fail.
- The long-term safety profile of compounds still in trials or sold as research chemicals — the FDA has not completed that review, which is precisely why several sit in Category 2.
Frequently Asked Questions
Is BPC-157 FDA approved?
No. BPC-157 is not approved by the FDA for any use. In its 2023 review of bulk drug substances for pharmacy compounding, the FDA placed BPC-157 in Category 2, citing significant safety-data gaps — which directs 503A compounding pharmacies to stop using it. An early-stage human trial (NCT07437547) is recruiting, but that is a long way from approval.
Is retatrutide FDA approved?
No, not yet. Retatrutide (LY3437943) is in Phase 3 clinical trials as part of Eli Lilly's TRIUMPH program (for example, NCT06297603). It is not available by prescription and cannot be legally sold as a drug until and unless the FDA approves it.
Which weight-loss peptides are actually FDA approved?
For weight management specifically: semaglutide (Wegovy), tirzepatide (Zepbound), liraglutide (Saxenda), and setmelanotide (Imcivree, for rare genetic obesity). The GLP-1s are also approved for type 2 diabetes under other brand names. Retatrutide, orforglipron, survodutide, cagrilintide, and mazdutide are still in trials.
Are compounded semaglutide and tirzepatide still legal?
Their legal basis narrowed sharply. Large-scale compounding of these drugs was permitted mainly because they were on the FDA shortage list. The FDA declared the tirzepatide shortage resolved in late 2024 and the semaglutide shortage resolved in February 2025, ending that exemption, with enforcement wind-down deadlines in 2025. The situation remains subject to litigation — confirm current rules with a licensed pharmacist.
Has the new administration changed peptide regulation?
New HHS leadership under Robert F. Kennedy Jr. (confirmed February 2025) has signaled interest in wellness and longevity medicine, which has fueled speculation about looser peptide rules. But as of the update date on this page, no formal rescheduling or new approval pathway for research peptides has been enacted. Treat "it's about to be approved" claims as speculation until an official FDA action confirms them.
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Educational purposes only. Not medical advice.
Regulatory status changes frequently and varies by jurisdiction. This page is a point-in-time snapshot as of the stated update date. Always verify current FDA status and consult a licensed clinician or pharmacist before making any decision.