Peptide reference
Bremelanotide
PT-141 ·Vyleesi ·Bremelanotide acetate ·MT-II analog
What cited sources report about Bremelanotide
Bremelanotide (PT-141, marketed as Vyleesi) is a synthetic cyclic heptapeptide melanocortin receptor agonist with preferential activity at MC4R, derived from the parent compound Melanotan II. It was approved by the FDA in June 2019 for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), self-administered as a 1.75 mg subcutaneous injection on demand. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
FDA DailyMed — Vyleesi prescribing information
The Vyleesi prescribing information describes bremelanotide as a melanocortin receptor agonist for premenopausal women with HSDD. Patients self-administer a single 1.75 mg subcutaneous dose at least 45 minutes before anticipated sexual activity using a single-dose autoinjector, with a maximum of one dose per 24 hours and 8 doses per month. The label includes warnings for transient blood-pressure increase, focal hyperpigmentation, and contraindication in uncontrolled hypertension or known cardiovascular disease.
VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
Simon et al. (2019) — Obstetrics & Gynecology (RECONNECT 52-week extension)
A 52-week open-label extension pooled data from the RECONNECT phase 3 program (Studies 301 and 302) and surveyed long-term safety and efficacy of subcutaneous bremelanotide 1.75 mg as needed in premenopausal women with HSDD. The authors reported sustained improvements in FSFI desire domain and FSDS-DAO scores, with the most common adverse events being nausea, flushing, and injection-site reactions.
Treatment with bremelanotide for up to 52 weeks was generally well tolerated, with sustained improvements in sexual desire and reductions in associated distress.
Koochaki et al. (2021) — Journal of Women’s Health
A validation analysis using pooled data from the RECONNECT phase 3 program surveyed the psychometric properties of the Female Sexual Function Index (FSFI) desire domain in premenopausal women with HSDD. The authors documented internal-consistency and known-groups validity of the desire domain as a primary trial endpoint.
ClinicalTrials.gov NCT02333071 — RECONNECT Study 301
RECONNECT Study 301 was a phase 3 randomized double-blind placebo-controlled study of subcutaneous bremelanotide 1.75 mg as needed in premenopausal women with HSDD, sponsored by Palatin Technologies and Amag Pharmaceuticals. Co-primary endpoints were change from baseline in FSFI desire domain and FSDS-DAO Item 13 at 24 weeks.
ClinicalTrials.gov NCT02338960 — RECONNECT Study 302
RECONNECT Study 302 was the second phase 3 pivotal study with identical design to Study 301. The two trials together formed the registration package supporting FDA approval of Vyleesi in June 2019.
PubChem CID 9941379 — National Center for Biotechnology Information
PubChem record for bremelanotide listing the synthetic cyclic heptapeptide Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH, molecular formula C50H68N14O10, molecular weight 1025.2 g/mol, and aggregated synonyms (PT-141, Vyleesi).
Coverage notes
Bremelanotide is one of only two FDA-approved pharmacotherapies for HSDD in premenopausal women (the other being flibanserin). Vyleesi is supplied as a single-use prefilled autoinjector; the EMA marketing authorization application was withdrawn by Amag Pharmaceuticals in 2020 prior to a final opinion. The peptide is unrelated to the unregulated tanning-peptide products marketed under similar names. This page reflects FDA labeling current as of the cited sources.