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
Monograph · APT-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.
How it clearsHalf cleared in ~2h. Most (~96%) gone by ~10h.

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.
Documented hormonal pathway with strong mechanistic support. Response is not uniform — users with significant baseline deficiency feel signal earlier and more clearly than those near the normal range. If response feels subtle, that is often a baseline reading, not a compound failure.
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.
Per-claim grading. Each claim is graded independently — same peptide, different claims can carry different grades.
- AStrong evidence
Bremelanotide (PT-141) improves desire/distress scores in HSDD trials vs placebo
1 supporting referencesVerified 23d ago
External links to PubMed searches, ClinicalTrials.gov, and FDA materials. We do not host papers — we point at canonical sources.
FDA 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.
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 2026-04No field reports yet
Field reports are added as users share their real-world protocols.
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