Bremelanotide (PT-141)
A cyclic heptapeptide melanocortin receptor agonist approved by the FDA (Vyleesi) for hypoactive sexual desire disorder. Included here as a reference profile only.
| Total citations | 4 |
|---|---|
| Human clinical studies | 3 |
| Animal models | 0 |
| In vitro studies | 0 |
| Reviews / meta-analyses | 1 |
Mechanism of action
Bremelanotide (Ac-Nle-cyclo-(Asp-His-D-Phe-Arg-Trp-Lys-OH)) is a non-selective melanocortin receptor agonist with highest affinity for MC4R and MC1R. It is a metabolite of the alpha-MSH analogue melanotan II.
Its effect on sexual desire is presumed to be mediated by MC4R activation in central pathways regulating sexual response. The FDA label states the precise mechanism of action for its indication is not known.
Peer-reviewed literature
Study type is tagged on every entry so animal and in-vitro findings are never mistaken for human clinical evidence.
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials
The RECONNECT phase 3 randomised trials supporting approval.
Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder
Open-label extension reporting longer-term safety.
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide
Subgroup analyses across the phase 3 programme.
Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder
A critical review questioning the clinical meaningfulness of the reported effect sizes.
Limitations & open questions
Bremelanotide is an FDA-approved prescription medicine. It is a regulated drug product, not a research chemical. Independent critical review has questioned the clinical significance of the effect size observed in the phase 3 programme.