Bremelanotide — Complete Research Guide (2026)

Last updated 2026-07-31

What is Bremelanotide?

Bremelanotide (brand name Vyleesi) is a synthetic melanocortin-receptor agonist peptide that the U.S. FDA approved in 2019 for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

It is a cyclic 7-amino-acid analog of alpha-melanocyte-stimulating hormone, delivered by a subcutaneous auto-injector on an as-needed basis roughly 45 minutes before anticipated sexual activity.

The efficacy evidence is strong for its indication: two pivotal phase 3 randomized controlled trials (the RECONNECT program) plus a 52-week open-label extension in premenopausal women with HSDD.

How does Bremelanotide work?

Bremelanotide non-selectively activates central melanocortin receptors (notably MC4R) in the brain, pathways involved in the regulation of sexual desire.

Its precise mechanism for improving HSDD is not fully established.

What does the research say about Bremelanotide?

• In two phase 3 RCTs, bremelanotide 1.75 mg given subcutaneously as needed produced statistically significant improvements in sexual desire and in desire-related distress versus placebo in premenopausal women with HSDD. ^[1]
• Improvements were sustained through a 52-week open-label extension with no new safety signals emerging over longer exposure. ^[2]
• Across the full clinical development program, adverse events were predominantly mild-to-moderate, dominated by nausea, flushing, and headache. ^[3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

• [1] Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials — Kingsberg SA et al., Obstetrics and Gynecology 2019. (Two pooled phase 3 randomized controlled trials (RECONNECT))
• [2] Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder — Simon JA et al., Obstetrics and Gynecology 2019. (52-week open-label extension study)
• [3] Safety Profile of Bremelanotide Across the Clinical Development Program — Clayton AH et al., Journal of Women's Health 2022. (Integrated safety analysis)
• [4] Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial — Clayton AH et al., Women's Health (London) 2016. (Phase 2b randomized placebo-controlled dose-finding trial)
• [5] Bremelanotide: First Approval — Dhillon S et al., Drugs 2019. (Drug approval review)

Dosing context

In the pivotal trials the studied and labeled regimen was a single 1.75 mg subcutaneous injection via auto-injector into the abdomen or thigh, taken as needed about 45 minutes before anticipated sexual activity.

This describes the studied and FDA-labeled use for context only and is not medical advice; any use must be individualized and supervised by a licensed clinician.

Side effects & safety profile

The most common adverse effects are nausea (sometimes severe enough to cause discontinuation), flushing, headache, and injection-site reactions; focal skin hyperpigmentation can occur, especially with repeated dosing.

Bremelanotide transiently raises blood pressure and lowers heart rate after each dose, so it is contraindicated in people with uncontrolled hypertension or known cardiovascular disease.

Use is capped at one dose per 24 hours and no more than eight doses per month, and it should be avoided with concurrent oral naltrexone due to a labeled interaction.

Stacking & combinations

Bremelanotide is a single-agent prescription product used on its own; it is not intended to be combined or stacked with other peptides, and caution is advised with drugs that affect blood pressure.

Finding Bremelanotide vendors

User reviews

Frequently asked questions

References

1. [1] Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials — Kingsberg SA et al., Obstetrics and Gynecology 2019. PMID: 31599840. View sourceStudy: Two pooled phase 3 randomized controlled trials (RECONNECT)Bremelanotide 1.75 mg SC significantly improved sexual desire and reduced desire-related distress versus placebo in premenopausal women with HSDD.
2. [2] Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder — Simon JA et al., Obstetrics and Gynecology 2019. PMID: 31599847. View sourceStudy: 52-week open-label extension studyBenefits were maintained over one year of open-label use, with the most common adverse events being nausea, flushing, sunburn, and headache.
3. [3] Safety Profile of Bremelanotide Across the Clinical Development Program — Clayton AH et al., Journal of Women's Health 2022. PMID: 35147466. View sourceStudy: Integrated safety analysisAcross roughly 3,500 subjects, adverse events were mostly mild-to-moderate, led by nausea, flushing, and headache.
4. [4] Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial — Clayton AH et al., Women's Health (London) 2016. PMID: 27181790. View sourceStudy: Phase 2b randomized placebo-controlled dose-finding trialIdentified the 1.75 mg dose as the best efficacy-tolerability balance, informing the phase 3 program.
5. [5] Bremelanotide: First Approval — Dhillon S et al., Drugs 2019. PMID: 31429064. View sourceStudy: Drug approval reviewSummarizes the melanocortin-agonist mechanism and the 2019 U.S. approval for premenopausal HSDD.

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