PT-141 — Wolverine Health

How it works

FDA-approved in June 2019 as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women. It acts centrally on melanocortin receptors — MC1R, MC3R, MC4R — to modulate dopaminergic signalling. The mechanism bypasses the vascular pathway that drugs like sildenafil target. Off-label interest in men exists; the approved evidence base is in women. Compounding is restricted as it's an approved drug.

FDA status: FDA-approved (NDA 210557) for hypoactive sexual desire disorder in premenopausal women. Brand: Vyleesi. Compounding restricted under FD&C Act.
WADA status: Permitted in sport
Route: subcutaneous injection (approved); intranasal (historical)

Key studies

Bremelanotide (Vyleesi) FDA Drug Approval — NDA 210557

Bremelanotide (Vyleesi) received FDA approval in June 2019 for the treatment of hypoactive sexual desire disorder in premenopausal women, based on two Phase III placebo-controlled trials.

Safety

Common adverse effects: nausea (40% in trials), flushing, injection-site reactions, transient blood pressure elevation. Contraindicated in cardiovascular disease and high CV risk. Self-administered no more than once per 24 hours.

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Research on PT-141

PT-141 / Bremelanotide: FDA-Drug-Approved Sexual Health Peptide and Off-Label Use

Science-journalism overview of PT-141 (bremelanotide) — the melanocortin agonist with regulatory approval for hypoactive sexual desire disorder in women, its mechanism, clinical evidence, and the off-label interest driving compounding demand.