What does the research show about bremelanotide?

Bremelanotide

In two phase 3 trials of 1,247 premenopausal women with low sexual desire, as-needed bremelanotide raised a desire score 0.35 points more than placebo and lowered related distress 0.33 points more. Nausea occurred in 40% against 1.3% on placebo. Blood pressure rose briefly after each dose, and 18% stopped because of side effects.

Add to Bio HackChecked 2026-11-09

Status: Prescription drug in the US. FDA-approved as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder. The label states it is not indicated for postmenopausal women, for men, or to enhance sexual performance.
Also called: Vyleesi, PT-141, BMT, melanocortin receptor agonist
Taken for: low libido, sexual desire, sexual arousal, sexual distress

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Shown to help3

ModerateShown to raise sexual desire scores by about 0.35 points over placebo on a 1.2 to 6 scale in premenopausal women with low desire.
ModerateShown to lower distress about low desire by about 0.33 points over placebo on a 0 to 4 scale in premenopausal women.
LimitedOne trial found satisfying sexual events rose 0.7 a month against 0.2 on placebo in premenopausal women with sexual dysfunction.

Reported risks5

ModerateShown to raise nausea to 40% against 1.3% on placebo, along with flushing, headache and vomiting. Most events were mild to moderate and passed.Very common
ModerateShown to raise stopping for side effects to 18% against 2% on placebo, most often because of nausea.Very common
LimitedLimited evidence: darkening of the face, gums or breasts occurred in 1% of women at labeled doses and 38% with daily dosing. It did not always fade.Common
LimitedLimited evidence: blood pressure rose up to 6 mmHg systolic and heart rate fell up to 5 beats per minute, peaking 2 to 4 hours after a dose.How often is not known
LimitedLimited evidence: bremelanotide lowered blood levels of indomethacin and naltrexone in pharmacology studies.How often is not known

What people take it for, and what was found

Shown to help3

ModerateStudied in women

Sexual desire in premenopausal women with low desire

Shown to raise sexual desire scores by about 0.35 points over placebo on a 1.2 to 6 scale in premenopausal women with low desire.

The numbers and sources

Effect: Over 24 weeks, the desire score rose 0.30 points more than placebo in one trial and 0.42 in the other, 0.35 points across both [1]. On that score, which runs from 1.2 to 6, mean change was 0.5 against 0.2 and 0.6 against 0.2 on placebo [2]. In a 12-week dose-finding trial, the total sexual function score rose 3.6 points against 1.9 on placebo [3].
Population: 1,247 premenopausal women with acquired, generalized hypoactive sexual desire disorder, mean age 39, 85.6% white, 96.6% at US sites [1]; 327 premenopausal women with female sexual dysfunction [3].
Sources: [1], [2], [3]
Caveats: The phase 3 trials were funded by Palatin Technologies and AMAG Pharmaceuticals [1]. The score is self-reported. The label limits use to premenopausal women [2].

Moderate

Distress about low sexual desire

Shown to lower distress about low desire by about 0.33 points over placebo on a 0 to 4 scale in premenopausal women.

The numbers and sources

Effect: Distress related to low desire fell 0.37 points more than placebo in one trial and 0.29 in the other, 0.33 points across both [1]. On that item, which runs from 0 to 4, mean change was -0.7 on bremelanotide and -0.4 on placebo in both trials [2]. In the dose-finding trial, the total distress score changed by -11.1 against -6.8 [3].
Population: As above [1][3].
Sources: [1], [2], [3]
Caveats: Same trials and funding as the desire outcome.

LimitedStudied in women

Satisfying sexual events

One trial found satisfying sexual events rose 0.7 a month against 0.2 on placebo in premenopausal women with sexual dysfunction.

The numbers and sources

Effect: In the dose-finding trial, satisfying sexual events rose 0.7 per month against 0.2 per month on placebo [3].
Population: 327 premenopausal women with female sexual dysfunction, 12 weeks [3].
Sources: [3]
Caveats: One phase 2 trial. The phase 3 abstracts do not report this measure [1].

Doses studied

The phase 3 trials used 1.75 mg by subcutaneous autoinjector, as needed, about 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours and no more than 12 doses a month. Most participants used it two to three times a month [2]. The dose-finding trial compared 0.75, 1.25 and 1.75 mg [3].

Risks

Reported risks5

ModerateStudied in womenVery common

Nausea, flushing and headache

Shown to raise nausea to 40% against 1.3% on placebo, along with flushing, headache and vomiting. Most events were mild to moderate and passed.

The numbers and sources

How common: Very common: more than 1 in 10 people.
Effect: In the controlled trials, nausea occurred in 40.0% on bremelanotide and 1.3% on placebo, flushing in 20.3% against 0.3%, injection site reactions in 13.2% against 8.4%, headache in 11.3% against 1.9%, and vomiting in 4.8% against 0.2%. Nausea needed anti-nausea medication in 13% [2]. In the 52-week open-label extension, drug-related nausea occurred in 40.4%, flushing in 20.6% and headache in 12.0% [4].
Population: 627 women on bremelanotide and 620 on placebo [2]; 684 women in the extension [4].
Sources: [2], [4]
Caveats: The label reports most events as mild to moderate and transient, and nausea improved for most people with the second dose [2]. The extension had no comparison group [4].

ModerateStudied in womenVery common

Stopping because of side effects

Shown to raise stopping for side effects to 18% against 2% on placebo, most often because of nausea.

The numbers and sources

How common: Very common: more than 1 in 10 people.
Effect: Adverse reactions led 18% on bremelanotide and 2% on placebo to stop, most often nausea (8%). Serious adverse reactions occurred in 1.1% against 0.5% [2]. 70% of the bremelanotide group continued into the open-label phase, against 87% of the placebo group [5].
Population: 1,247 women in the controlled trials [2][5].
Sources: [2], [5]
Caveats: In the extension, 272 of 684 women completed 52 weeks [4].

LimitedCommon

Darkening of the skin and gums

Limited evidence: darkening of the face, gums or breasts occurred in 1% of women at labeled doses and 38% with daily dosing. It did not always fade.

The numbers and sources

How common: Common: between 1 in 100 and 1 in 10 people.
Effect: Focal hyperpigmentation, including the face, gums and breasts, was reported in 1% of women using up to 8 doses a month, against none on placebo. In another study, 38% developed it after daily dosing for 8 days. It was more likely in people with darker skin, and it did not resolve in all patients after stopping [2].
Population: Phase 3 participants and a daily-dosing study [2][5].
Sources: [2], [5]
Caveats: The daily-dosing study used a schedule outside the labeled use [2].

LimitedHow often is not known

Brief rise in blood pressure and fall in heart rate

Limited evidence: blood pressure rose up to 6 mmHg systolic and heart rate fell up to 5 beats per minute, peaking 2 to 4 hours after a dose.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Systolic blood pressure rose by up to 6 mm Hg and diastolic by up to 3 mm Hg, peaking 2 to 4 hours after a dose, with heart rate falling by up to 5 beats per minute. These changes usually resolved within 12 hours [2]. Ambulatory monitoring found small, transient rises [5].
Population: Clinical study participants [2][5].
Sources: [2], [5]
Caveats: The label advises against use in people at high risk for cardiovascular disease and asks that blood pressure be controlled before starting [2].

LimitedHow often is not known

Drug interactions

Limited evidence: bremelanotide lowered blood levels of indomethacin and naltrexone in pharmacology studies.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Bremelanotide lowered blood concentrations of indomethacin and naltrexone. Other interactions studied were not judged clinically significant [5].
Population: Clinical pharmacology studies in the development program [5].
Sources: [5]
Caveats: A review of the sponsor's development program.

Sources

Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics and Gynecology. 2019. https://doi.org/10.1097/AOG.0000000000003500
U.S. Food and Drug Administration. VYLEESI (bremelanotide injection), prescribing information. Revised 2024. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
Clayton AH, Althof SE, Kingsberg S, et al. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women's Health. 2016. https://doi.org/10.2217/whe-2016-0018
Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstetrics and Gynecology. 2019. https://doi.org/10.1097/AOG.0000000000003514
Clayton AH, Kingsberg SA, Portman D, et al. Safety Profile of Bremelanotide Across the Clinical Development Program. Journal of Women's Health. 2022. https://doi.org/10.1089/jwh.2021.0191

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