As of September 2026, the FDA has approved bremelanotide, also called PT-141, for one use. As Vyleesi, it is for premenopausal women with hypoactive sexual desire disorder, a diagnosis of low sexual desire. No EU marketing authorisation was found. That approval covers Vyleesi. A vial sold as PT-141 is a separate question, and you have no way to see inside it.
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What is PT-141?
PT-141 is another name for bremelanotide, a compound that acts on melanocortin receptors in the brain. It came out of 1980s research at the University of Arizona into compounds modeled on melanocyte-stimulating hormone, first explored for sunless tanning. Palatin Technologies developed it, and the FDA approved it as Vyleesi in June 2019.
Does PT-141 work?
For its approved use, the FDA reviewed two Phase 3 trials and approved it as Vyleesi. That use is hypoactive sexual desire disorder in premenopausal women, and the record shows no other approved use.
What we found. 2 completed randomized trials counted on the record, the two Phase 3 trials behind the approval. 1 earlier program, discontinued over a blood pressure safety signal.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| The two Phase 3 trials in the approval file, NDA 210557 | People | Completed, reviewed by the FDA | They supported the approval for hypoactive sexual desire disorder in premenopausal women |
| Trials of an earlier version | People | Discontinued | The earlier program was halted over a blood pressure safety signal, and the product was then reformulated |
Is PT-141 safe?
The record lists these documented concerns: nausea, flushing, headache, short-lived rises in blood pressure, and skin darkening with frequent use. An earlier version was halted over a blood pressure safety signal. Heart and blood-vessel safety over several years is an open point: the record calls those data limited, with reports after approval still accumulating. All of that describes Vyleesi, the earlier version and their trials. A vial from another source is a different matter, taken up below.
Is PT-141 legal?
- United States
- Approved by the FDA in June 2019 as Vyleesi, for premenopausal women with acquired, generalized hypoactive sexual desire disorder.
- European Union
- No EU marketing authorisation found.
- Sport
- Not named on WADA's list. That is not clearance.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as PT-141?
The FDA approved one product, Vyleesi. This record holds no sign that PT-141 is sold outside pharmacies. If a vial with that name reached you another way, the approval does not cover it, and the checklist lists what to ask the seller.
What don't we know?
- What it does to the heart and blood vessels over several years. Those data are limited.
- What reports after approval will show. The record says they are still accumulating.
- Whether it does anything outside its one approved use. The record shows no other approval.
- What is in any vial that did not come from a pharmacy.
The other side
Vyleesi comes with a prescription and a doctor's care, and two Phase 3 trials stand behind its approval. The open questions on this page are long-term heart and blood-vessel safety, and any vial sold as PT-141 from somewhere else.
What would change this record?
- Published long-term safety data from use after approval, or REMS-related safety data. Either would clarify long-term risk to the heart and blood vessels.
Three questions to ask next
- What does 'research use only' actually mean?
- How can you tell if a peptide vendor is legitimate?
- How do you read a certificate of analysis?
Ask better questions.
More questions about PT-141
Is PT-141 the same as Vyleesi?
- PT-141 and Vyleesi are both names for bremelanotide. Vyleesi is the brand the FDA approved in June 2019, and the approval covers that product.
Is PT-141 approved for men?
- Not on this record. Its one approval is for premenopausal women with hypoactive sexual desire disorder.
Why was the earlier version of PT-141 stopped?
- Over a blood pressure safety signal. The record says the earlier program was halted and the product was then reformulated.
Is PT-141 the same as melanotan II?
- No. The record calls melanotan II a related analog. It showed effects on sexual arousal in early human testing, and bremelanotide is a modified version developed after that.
Is PT-141 banned in sport?
- It is not named on WADA's list. The record gives no sport source for that. If you compete, check the current List.
Record checked on . Each source shows the date it was checked.