Bremelanotide (Vyleesi): FDA-Approved Peptide for Low Sexual Desire in Women — Clinical Review | Research

The takeaway

Bremelanotide (Vyleesi), the second FDA-approved treatment for female hypoactive sexual desire disorder, is a melanocortin-4 receptor agonist injected as-needed before sex with modest clinical benefit.

2nd FDA-approved HSDD drug
Bremelanotide is the only as-needed injection for female sexual desire disorder, working through melanocortin brain pathways

What the researchers found

Bremelanotide significantly improved desire and reduced HSDD-related distress in Phase 2/3 trials, with nausea (39.9%), flushing (20.4%), and headache (11%) as main side effects.

Why it matters

HSDD affects 8-10% of premenopausal women. As only the second FDA-approved treatment (after flibanserin), bremelanotide provides an as-needed option working through a novel brain mechanism.

The numbers in context

1.75 mg SC; nausea 39.9%, flushing 20.4%, headache 11%; max 1/day, 8/month; significant improvement in desire and desire-related distress

How the study worked

Systematic review of Phase 2 and 3 clinical trials from Medline, SCOPUS, EMBASE (1996-2019); 2 Phase 3 and 2 Phase 2 trial reports analyzed.

Who was studied

Premenopausal women with hypoactive sexual desire disorder (HSDD) across phase 2 and 3 clinical trials

What this study cannot tell us

Clinical benefit described as "modest" despite statistical significance; high nausea rate (40%); subcutaneous injection may be a barrier; long-term safety data limited; no comparison to flibanserin.

How to read the evidence

High — FDA-approved based on Phase 2/3 randomized controlled trial evidence.

When this study was published

Published in 2020; bremelanotide has been available since FDA approval in 2019.

The bigger picture

Bremelanotide works through melanocortin receptors in the brain — a fundamentally different pathway from hormonal approaches. It validates the concept of peptide-based sexual medicine.

Questions still open

How does bremelanotide compare directly to flibanserin in efficacy and tolerability?
Does the nausea improve with repeated use?
Could lower doses reduce nausea while maintaining efficacy?

Common questions

How does bremelanotide work?

It activates melanocortin-4 receptors in the brain that regulate sexual desire. Unlike hormonal treatments, it works through the brain's central nervous system pathways.

Is the 40% nausea rate a dealbreaker?

Many women tolerate it and the nausea may improve with use. It's typically transient and doesn't require treatment, but it's important to be aware of before starting.

Read the original research

Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.

The Annals of pharmacotherapy, 54(7), 684-690

View on PubMed ↗Publisher’s paper ↗

Citation

Mayer, Danielle; Lynch, Sarah E. (2020). Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.. The Annals of pharmacotherapy, 54(7), 684-690. https://doi.org/10.1177/1060028019899152