Libido
Desire, on demand
Bremelanotide acts on the brain's arousal pathways to increase desire in men and women.
Ships as a freeze-dried powder. Need water to mix it? Add Reconstitution Solution.
The science
Evidence level
5/5
FDA-approved compound
Bremelanotide is FDA-approved as VYLEESI for specific premenopausal HSDD; this is a compounded preparation, not VYLEESI.
1,2671
women randomized across two phase 3 RECONNECT trials
7 of 73
responder endpoints significant versus placebo at 1.75 mg in phase 2b
52 wk2
open-label extension with desire improvements maintained
Mechanism of action
Targets & pathways
Bremelanotide is a cyclic melanocortin agonist, with activity at MC4R and MC1R most relevant at therapeutic doses5.
MC4R is expressed in brain circuits involved in sexual response, where bremelanotide is believed to act, rather than on vascular function5.
Used as needed before sexual activity, it improved patient-reported desire and reduced desire-related distress versus placebo in both phase 3 trials1.
In a 52-week open-label extension, women who continued treatment maintained their desire and distress improvements2.
What the research shows
Both 24-week RECONNECT trials found improvements in desire and reductions in distress versus placebo.
At 1.75 mg, responder rates beat placebo on all 7 patient-reported endpoints in phase 2b.
Desire scores improved by 1.25 to 1.30 points over 52 weeks among women who received bremelanotide from the start.
Bremelanotide is approved as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder.
Prespecified and integrated subgroup analyses explored the RECONNECT trial population.
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.
Journal of women's health (2002) · 2022
PubMed ↗ (opens in a new tab)Two 24-week trials randomized 1,267 women; integrated placebo-adjusted desire and distress differences were +0.35 and -0.33 score units.
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.
Obstetrics and gynecology · 2019
PubMed ↗ (opens in a new tab)Responder analyses examined clinically meaningful patient-reported changes in dose-ranging research.
Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.
The journal of sexual medicine · 2019
PubMed ↗ (opens in a new tab)Questions
Bremelanotide is a distinct melanocortin agonist with a specific branded FDA-approved indication; Melanotan II does not share that approval.
No. The branded HSDD indication does not include men or postmenopausal women.
The approved label does not indicate it for enhanced sexual performance, and trial benefits concerned desire and distress.
No. The displayed difference is a patient-reported scale score relative to placebo.
The active-molecule name does not establish equivalent formulation, delivery device, concentration, quality or exposure.