Bremelanotide (Vyleesi): FDA-Approved Peptide for Low Sexual Desire in Women — Clinical Review
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?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?
Trust & Context
- Key Stat:
- 2nd FDA-approved HSDD drug Bremelanotide is the only as-needed injection for female sexual desire disorder, working through melanocortin brain pathways
- Evidence Grade:
- High — FDA-approved based on Phase 2/3 randomized controlled trial evidence.
- Study Age:
- Published in 2020; bremelanotide has been available since FDA approval in 2019.
- Original Title:
- Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.
- Published In:
- The Annals of pharmacotherapy, 54(7), 684-690 (2020)
- Authors:
- Mayer, Danielle, Lynch, Sarah E
- Database ID:
- RPEP-04991
Evidence Hierarchy
Summarizes existing research on a topic.
What do these levels mean? →Frequently Asked 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 More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-04991APA
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
MLA
Mayer, Danielle, et al. "Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.." The Annals of pharmacotherapy, 2020. https://doi.org/10.1177/1060028019899152
RethinkPeptides
RethinkPeptides Research Database. "Bremelanotide: New Drug Approved for Treating Hypoactive Sex..." RPEP-04991. Retrieved from https://rethinkpeptides.com/research/mayer-2020-bremelanotide-new-drug-approved
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.