Compound guide · Tier A
PT-141
An approved medicine for premenopausal women with low sexual desire, bought overwhelmingly by men for something it was not approved to treat.
The short answer
PT-141 is a real drug with a real licence, and the licence describes a population and an indication almost none of its buyers match. Vyleesi was approved for hypoactive sexual desire disorder in premenopausal women, following trials in that population, in the United States only. The men buying research grade PT-141 for erectile function or libido are outside the studied population, outside the approved indication, and outside the country where the approval applies. The mechanism is genuinely unusual and genuinely central rather than vascular, which is what makes it interesting. That is not the same as an evidence base for the use it is actually bought for.
At a glance
| Class | Melanocortin receptor agonist |
| Developer | Palatin Technologies |
| Sold as | Vyleesi (bremelanotide) |
| Regulatory status | Approved in the United States only. The FDA approved bremelanotide on 21 June 2019 as Vyleesi, for hypoactive sexual desire disorder in premenopausal women. As of mid 2026 it has no marketing authorisation in the European Union, the United Kingdom or Canada. The indication is narrow and it is specific to a population that most buyers are not in. |
| Compounding status | Bremelanotide is an approved drug product in the US, so compounded and research grade PT-141 sit outside an approved supply chain that does exist. That is a different situation from compounds where no approved version exists at all, and it means an approved, prescribed route is available to the population the drug was licensed for. |
| Anti-doping | Not specifically named on the prohibited list. As with any hormonally active compound, use in tested sport should be checked against the list as published each year. |
| Our evidence tier | Tier A. Approved medicine |
What it is
Bremelanotide is a synthetic melanocortin receptor agonist, a cyclic peptide related to alpha melanocyte stimulating hormone. Unlike PDE5 inhibitors, which act on blood flow, it acts on melanocortin receptors in the central nervous system and is understood to work on the desire pathway rather than the vascular one. It is a metabolite of melanotan II, which is the reason the two compounds keep appearing in the same conversations despite one being an approved medicine and the other carrying regulator warnings.
Who it is for, and who actually takes it
The approved population is premenopausal women with acquired, generalised hypoactive sexual desire disorder, meaning low desire that causes distress and is not better explained by another condition, a relationship problem, or a medication. The registration trials were conducted in that group.
It is bought predominantly by men, for libido and erectile function. Neither was the approved indication and neither population was the subject of the registration trials. Interest in it as a general sexual performance compound runs far ahead of the evidence that earned it a licence.
What the research shows
The registration endpoints were validated desire and distress questionnaire scores, which are meaningful inside the trial and do not translate into an honest single bar chart for a general reader.
Dosing
| Stage | Dose |
|---|---|
| Approved indication | Hypoactive sexual desire disorder in premenopausal women |
| Approved territory | United States. Not authorised in the EU, UK or Canada as of mid 2026 |
| Route | Subcutaneous autoinjector |
| Label strength | 1.75 mg per dose |
| Label timing | As needed, at least 45 minutes before anticipated sexual activity |
| Label limits | No more than one dose in 24 hours, and no more than eight doses per month |
This reproduces the published Vyleesi label because a licensed medicine is a matter of public record. It applies to an approved product, in the approved population, in the country where it is authorised. The monthly dose limit on the label is not decoration, and note that no equivalent guidance exists for the population that mostly buys this compound, because that population was not studied. We publish no reconstitution guidance.
What happens when you come off it
Vyleesi is used episodically rather than continuously, so the question of discontinuation looks different from the chronic compounds on this site. There is no withdrawal syndrome described in the label, and there is equally no evidence of a persisting effect after use.
What it is being studied for
| Area | Stage of evidence |
|---|---|
| Hypoactive sexual desire disorder, premenopausal women | Approved, United States |
| Erectile dysfunction in men | Earlier development, did not lead to approval in that indication |
| Libido in men generally | No approved indication and no controlled evidence supporting the use |
| Postmenopausal women | Not the approved population |
An earlier development programme did explore male sexual dysfunction, and it is not the programme that produced the approval. The licence that exists is for premenopausal women, and citing the approval as support for male use inverts the actual regulatory history.
Common myths
PT-141 is FDA approved for sexual dysfunction.
It is FDA approved for hypoactive sexual desire disorder in premenopausal women. That is a specific diagnosis in a specific population. It is not an approval for sexual dysfunction in general and certainly not for men.
It works everywhere because it is approved.
The approval is United States only. As of mid 2026 there is no marketing authorisation in the EU, the UK or Canada, which means in most of the world there is no approved bremelanotide product at all.
It is basically the same as melanotan II but safer.
Bremelanotide is a metabolite of melanotan II and the two are pharmacologically related, which is exactly why the comparison is dangerous rather than reassuring. Bremelanotide went through a registration programme and carries a label. Melanotan II never did, is unlicensed everywhere, and carries regulator warnings and melanoma case reports. Relatedness is not equivalence.
More is better if a normal dose does not work.
The approved label caps use at one dose in 24 hours and eight doses per month. Nausea is the most common adverse effect and it is dose related. Transient blood pressure increases and heart rate reductions are described in the labelling.
Verifying a purchase
PT-141 and melanotan II are structurally close, which makes identity confirmation the priority check rather than a formality. Insist on mass spectrometry rather than an HPLC purity figure alone, because purity tells you the vial contains one thing consistently and says nothing about which melanocortin peptide it is. Confirm the report is tied to the batch code on your vial.
The general method is set out in our guide to reading a certificate of analysis, which covers the eleven checks that apply to any compound. The points above are the ones specific to PT-141.
Caveats and safety
The approved label describes nausea as the most common adverse effect, sometimes severe enough to stop treatment, together with transient increases in blood pressure and decreases in heart rate, which is why the label addresses uncontrolled hypertension and cardiovascular disease. Focal hyperpigmentation has been reported, more commonly with more frequent use, which is the melanocortin mechanism showing itself. None of this is monitored around a research vial.
Where to get it
Where to get it
CertaPeptides Romania, EU. Volume discounts at 3+, 5+ and 10+ units.
| Vial | Price |
|---|---|
| 10 mg | €41.99 |
Stated purity. ≥98% stated batch specification, with selected lots independently tested.
Documentation. Selected lots independently tested by Janoshik Analytical (Czech Republic), HPLC plus mass spectrometry, reports searchable on the Janoshik public portal and at certapeptides.com/verify.
PT-141 is sold as laboratory research material. The vendor states it is not for human consumption and that it is not approved by the FDA, the EMA or any other regulator for use in humans or animals. Read the evidence tier at the top of this page before the price.
View PT-141 at CertaPeptidesAffiliate link. We earn a commission if you buy, at no extra cost to you. It does not change a word of the assessment above. Every product we have priced, in one list.
Sources
- Drugs@FDA record for bremelanotide (Vyleesi)
- Vyleesi FDA approval history, Drugs.com
- Palatin Technologies regulatory announcements
- Registered bremelanotide trials, ClinicalTrials.gov
Related compounds
Disclosure. PeptoPurity is an affiliate of CertaPeptides and earns a commission on qualifying purchases made through the vendor link on this page, at no additional cost to you. That relationship does not set the evidence tier, alter the verdict, or change a word of the assessment. Our Tier C and Tier D pages carry the same links as our Tier A pages, with the same conclusions we would publish if we earned nothing. Where the registered, prescribed route is the better option, we say so on the page that would otherwise pay us.
Scope. This is an evidence review, not medical advice. Where an approved label schedule is reproduced it is a record of what a regulator has published about a licensed medicine, not a recommendation and not a schedule for anyone to follow unsupervised. For unapproved compounds we report only the doses used in published studies, attributed to those studies, and we publish no protocols and no reconstitution guidance for any compound. Regulatory status differs between countries and changes over time. Material sold for laboratory research is not approved for human use. Decisions about treatment belong with a qualified prescriber.