Bremelanotide (PT-141, brand: Vyleesi) was FDA-approved June 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women based on the RECONNECT-1 and RECONNECT-2 Phase 3 trials. ~25% of treated women showed improvement on FSFI desire domain vs placebo. Real but modest effect size; transient blood-pressure elevation noted.
Source →PT-141 (Bremelanotide)
Cyclic seven-amino acid melanocortin receptor agonist (MC3R/MC4R selective). Activates central nervous system pathways involved in sexual arousal — distinct from PDE5 inhibitors.
FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women (2019). Mechanism is central, not peripheral vascular. Side effects include nausea (common at first dose), transient blood pressure elevation, and skin darkening with repeated use.
Approved indication is narrow (premenopausal HSDD). Off-label use in men or postmenopausal women is grey-market. Blood pressure elevation requires monitoring in cardiovascular-risk patients.
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH. Cyclic, modified residues.
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PT-141 is widely prescribed off-label for men with PDE5-inhibitor-refractory libido issues and postmenopausal women. The melanocortin mechanism is orthogonal to vascular ED drugs, so combination with sildenafil/tadalafil is mechanistically reasonable but should be supervised. Cardiovascular-risk patients require careful screening.
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- BModerate evidence
PT-141 (Bremelanotide) — primary mechanism: cyclic seven-amino acid melanocortin receptor agonist (mc3r/mc4r selective). activates central nervous system pathways involved in sexual arousal — distinct from pde5 inhibitors.
2 supporting referencesVerified 5d ago
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Pre-filled with this compound's published dose range: 1.75 mg · as-needed before activity, subcutaneous
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Vyleesi brand — premenopausal HSDD indication. On-demand dosing 45 min before activity. Insurance variable.
As of 2026-04503A compounded PT-141 widely available with prescription, including off-label use cases.
As of 2026-04Research-grey range.
As of 2026-04FDA approved (Vyleesi) — premenopausal HSDD only
PT-141 (Vyleesi) FDA-approved for premenopausal HSDD
FDA approved Bremelanotide (PT-141, brand: Vyleesi) for hypoactive sexual desire disorder (HSDD) in premenopausal women. Self-injected pen, on-demand dosing 45 minutes before sexual activity.