Home / Peptides / Bremelanotide: One Approved Use, a Modest Effect
Bremelanotide: One Approved Use, a Modest Effect
Bremelanotide (Vyleesi) is FDA-approved only for premenopausal women with acquired, generalized HSDD. What trials showed, the risks and what isn't proven.
On this page
Quick facts
Fact sheet
- U.S. status
- Strongest evidence
- Human trials
- Status verified
A peptide drug for a narrow group of women, with a statistically real but modest effect, a high dropout rate in its trials and a few unusual side effects. And a very different thing from the “PT-141” sold as a research product.
Key takeaways
- Bremelanotide is FDA-approved as Vyleesi for one use: premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Brand names are used here only to identify the label.
- The effect is modest and its meaning is disputed. In two phase 3 trials, desire and distress scores improved by statistically significant but small amounts, and a published critique questions how meaningful they are.
- It did not increase the number of satisfying sexual events compared with placebo in those trials.
- Tolerability was a problem in the trials. About 40% of people reported nausea, and 18% stopped because of side effects, vs 2% on placebo.
- The label contraindicates it with uncontrolled high blood pressure or known cardiovascular disease, and it can darken patches of skin and gums, which did not clear in all patients.
- Its label says it is not indicated for men, for postmenopausal women or to enhance sexual performance.
What is bremelanotide approved for?
Vyleesi (bremelanotide) was approved by FDA on June 21, 2019 (Drugs@FDA). It is a prescription drug. The label’s indication is premenopausal women with acquired, generalized HSDD: low desire that causes marked distress or interpersonal difficulty and that is not due to another medical or psychiatric condition, to the relationship or to a drug (FDA label, rev. 10/2026).
What the label rules out: it is “not indicated for the treatment of HSDD in postmenopausal women or in men” and “not indicated to enhance sexual performance.”
How it works is not known. The label says: “The mechanism by which VYLEESI improves HSDD in women is unknown.” It acts on melanocortin receptors, mainly MC1R and MC4R. MC1R is found in pigment cells, which fits the skin-darkening side effect.
About the label date. FDA approved a label supplement on Oct. 22, 2026 that changed the lactation and pregnancy section. The indication, contraindication and warnings are the same. Dosing and use are set by the label and your prescriber; this guide does not give doses.
What did the trials show?
The approval rests on two identical phase 3 trials called RECONNECT (studies 301 and 302). They were randomized 1 to 1, double-blind, placebo-controlled and lasted 24 weeks, in premenopausal women with acquired, generalized HSDD of at least 6 months, using the drug as needed. The article lists Palatin and AMAG as its funding sources (Kingsberg 2019; NCT02333071, NCT02338960).
- Who: 1,267 women were randomized (1,247 in the safety analysis and 1,202 in the efficacy analysis). The average age was 39, 85.6% were white and 96.6% were in the United States.
- Desire (FSFI desire domain, scale 1.2 to 6): the difference from placebo was +0.30 in one trial and +0.42 in the other; pooled, +0.35 (P<0.001) (Kingsberg 2019). The label reports mean changes of +0.5 vs +0.2 and +0.6 vs +0.2 (label).
- Distress (FSDS-DAO item 13, scale 0 to 4): differences of −0.37 and −0.29; pooled, −0.33 (Kingsberg 2019). The label reports −0.7 vs −0.4 in both.
- Satisfying sexual events: no difference. The label shows changes of 0.0 vs −0.1 (P=0.76) and 0.0 vs 0.0 (P=0.70).
- Dropout: before 24 weeks, 40% vs 13% in one trial and 39% vs 25% in the other. Stopping because of side effects: 18% vs 2% (label).
What this adds up to. Statistically significant improvements in two scores, on small scales, and no improvement in satisfying events. This is the evidence for the approved use. It is controlled, published and tested a clinical outcome, but the effect is modest and its clinical meaning is disputed.
What do critics say?
A critique in the Journal of Sex Research argued that:
- the validity of the two main scales in HSDD is “questionable, at best”;
- 8 of 11 registered outcomes were not published, and in those, effects ranged from null to small;
- several favorable results were probably post hoc.
Statistical significance is not in dispute. Size and clinical meaning are.
What about the longer follow-up?
An open-label extension lasted 52 weeks. Of 856 eligible women, 684 entered and 272 finished. It had no control group, and the authors reported no new safety signals. Because it is uncontrolled and many dropped out, we don’t cite its improvements as an effect of the drug.
What are the risks?
From the Vyleesi label, rev. 10/2026. There is no boxed warning.
| Risk | What the label says |
|---|---|
| Contraindicated | Uncontrolled high blood pressure or known cardiovascular disease. Not recommended with high cardiovascular risk |
| Blood pressure and pulse | Peak rises of up to 6 mmHg systolic and 3 diastolic at 2 to 4 hours; pulse up to 5 beats per minute lower. Usually back to baseline within 12 hours |
| Focal skin darkening | 1% in phase 3, on the face, gums and breasts, vs 0% on placebo. In another study with daily use, 38% at 8 days and another 14% at 16 days. More in darker skin. Not confirmed to go away in all patients |
| Nausea | 40% vs 1%, mostly with the first dose. An anti-nausea drug was used in 13%; 8% stopped. Taking ondansetron beforehand did not reduce it (a trial of 228 healthy women) |
| Other common effects | Flushing 20.3% vs 0.3%; injection site 13.2% vs 8.4%; headache 11.3% vs 1.9%; vomiting 4.8% vs 0.2% |
| Serious events | 1.1% vs 0.5% |
| Liver | One case of acute hepatitis in the extension; a role for the drug could not be ruled out |
| Interactions | May delay absorption of oral drugs. Avoid with oral naltrexone for addiction |
| Pregnancy | Not enough human data; fetal harm in animals. Stop if pregnancy is suspected |
| Lactation (new, 10/2026) | 10 women, one dose: passage into milk “clinically insignificant,” relative infant dose 0.132%. Effects on infants were not evaluated |
| Other groups | Efficacy and safety not established in children or older adults. Caution in severe kidney impairment |
The label asks to stop treatment if there is no improvement after 8 weeks. That is for your prescriber, not a do-it-yourself rule.
What about men, tanning and other uses?
None of these is an approved use, and we separate them from the evidence above.
- Men and erectile dysfunction. The label says it is not indicated for men. The one randomized trial in men that we found, of an intranasal form, carries a published expression of concern from its journal, so we do not treat it as evidence. We did not review older early-phase studies in men. Desire in men has only an opinion piece; a case report of a man with lifelong anorgasmia lists bremelanotide among drugs that did not help him.
- Postmenopausal women. The label says it is not indicated. We found no trial in PubMed.
- Tanning. We found no trial, and darkening of skin is listed as an adverse effect on the label. It is not a benefit. Bremelanotide is often confused with Melanotan II, which is a different, unapproved substance.
- Sexual performance. The label says it is not indicated for this.
- Obesity. A triple-blind phase 2 trial of bremelanotide with tirzepatide (NCT06565611, planned for 108 people, sponsor Palatin) is listed as active and no longer recruiting, with no results in the registry.
We did not review animal or lab studies for this page, and any use supported only by them would not count as human evidence.
Is “PT-141” sold online the same as Vyleesi?
No. “PT-141” is another name for bremelanotide, but a vial from a seller is not the approved product. FDA has sent warning letters to companies selling peptide products labeled “PT-141,” calling them unapproved new drugs (FDA letter). The trial results above come from the approved product and cannot be carried over to those products. We do not link to or recommend sellers.
Compounded drugs are not FDA-approved, and FDA does not review them to evaluate their safety, effectiveness or quality before they reach patients.
Do not mix up the risks of the other substance: FDA reports melanoma, encephalopathy and priapism with Melanotan II. We do not attribute them to bremelanotide.
Which claims are not supported?
- “Female Viagra.” It acts on desire in HSDD, with a modest effect, and did not increase satisfying events.
- “It works for men.” The label says it is not indicated for men.
- “It’s for all women.” Not for postmenopausal women or for low desire due to another cause.
- “It enhances sexual performance.” The label excludes it.
- “It tans you.” Darkening is an adverse effect that may not go away.
- “PT-141 online is the same as Vyleesi.” It is not the approved product.
What should you ask your doctor?
- Could my low desire have another cause (a medical or psychiatric condition, a medicine, my relationship)? The label’s indication excludes those.
- Do I have high blood pressure or cardiovascular disease? They are contraindications.
- What would we use to tell whether it is helping, and when would we stop?
- What if I have nausea, or notice dark patches on my skin or gums?
- Which product is this: the approved one or something else? Who makes it?
We do not give doses, timing or preparation instructions, and we do not recommend sellers.
Frequently asked questions
Is bremelanotide FDA-approved?
Yes, as Vyleesi, for premenopausal women with acquired, generalized HSDD.
Does bremelanotide work?
In two phase 3 trials it produced statistically significant but small improvements in desire and distress scores, and did not increase satisfying sexual events. A published critique questions how meaningful the effect is.
Is bremelanotide for men?
No. The label says it is not indicated for men.
Does it cause skin darkening?
Yes, in some people. The label lists focal darkening of the skin and gums, and it was not confirmed to go away in all patients.
Is PT-141 the same as Vyleesi?
PT-141 is another name for bremelanotide, but a product sold online as a research peptide is not the approved drug.
Sources we checked
- Vyleesi prescribing information (FDA, rev. 10/2026)FDA. Accessed .
- FDA approval letter, supplement S-005, Oct. 22, 2026FDA. Accessed .
- Drugs@FDA: NDA 210557 (Vyleesi)FDA. Accessed .
- Kingsberg 2019: RECONNECT phase 3 trials of bremelanotide, Obstet Gynecol (PubMed)PubMed. Accessed .
- ClinicalTrials.gov NCT02333071 (RECONNECT, study 301)ClinicalTrials.gov. Accessed .
- ClinicalTrials.gov NCT02338960 (RECONNECT, study 302)ClinicalTrials.gov. Accessed .
- Simon 2019: open-label extension of bremelanotide trials (PubMed)PubMed. Accessed .
- Spielmans and Ellefson: critique of the bremelanotide trials, J Sex Res (PubMed)PubMed. Accessed .
- Expression of concern on a trial of intranasal bremelanotide in men (PubMed)PubMed. Accessed .
- ClinicalTrials.gov NCT06565611 (bremelanotide with tirzepatide, phase 2)ClinicalTrials.gov. Accessed .
- FDA: bulk drug substances that may present significant safety risksFDA. Accessed .
- FDA warning letter, Aug. 24, 2026 (peptide product labeled PT-141)FDA. Accessed .
- FDA: compounding laws and policiesFDA. Accessed .
- Pfaus and Balon: opinion on bremelanotide and desire in men (PubMed)PubMed. Accessed .
- Saffati 2023: case report of anorgasmia in a man, in which bremelanotide did not help (PubMed)PubMed. Accessed .
Written and maintained by the Best Peptides For Editorial Team. How we rate evidence.