Vitality
A medicine for low sexual desire in premenopausal women
FDA-approved · by prescriptionBremelanotide (Vyleesi) is FDA-approved to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women; it is not approved for men or postmenopausal women.
Consultations are opening state by state.
Important safety information. Vyleesi can briefly raise blood pressure after each dose and is not for people with uncontrolled high blood pressure or known cardiovascular disease; nausea is common, and darkening of the skin or gums may not go away. See safety
PT-141, known generically as bremelanotide and sold as Vyleesi, is FDA-approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is not approved for men or postmenopausal women. It acts on melanocortin receptors in the brain rather than on blood flow, unlike PDE5 inhibitors such as sildenafil.
Also known as Bremelanotide · Vyleesi
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH
Bremelanotide is a nonselective melanocortin receptor agonist (label potency order MC1R, MC4R, MC3R, MC5R, MC2R; MC1R and MC4R are most relevant at therapeutic doses). MC4R-expressing neurons are widespread in the brain, but the mechanism by which Vyleesi improves HSDD in women is unknown (FDA label); it does not work by peripheral vasodilation like PDE5 inhibitors. MC1R activation on melanocytes explains the focal hyperpigmentation seen with repeated dosing.
Evidence · FDA-approved · regulatory-grade trials
In two identical 24-week phase 3 trials (RECONNECT; 1,247 premenopausal women with acquired, generalized HSDD), as-needed Vyleesi 1.75 mg produced small but statistically significant improvements vs placebo in sexual desire (FSFI-Desire mean change +0.5 to +0.6 vs +0.2 on a 1.2-6.0 scale) and in distress about low desire (FSDS-DAO Q13); more Vyleesi patients left the double-blind phase early (39-40% vs 13-25%).
premenopausal women with acquired, generalized HSDD
An early double-blind, placebo-controlled dose-ranging study of an intranasal form (not an approved route) in healthy men and men with mild-to-moderate erectile dysfunction found dose-dependent erectile responses and described its pharmacokinetics and safety; Vyleesi is not approved for men.
healthy males and men with mild-to-moderate ED
Subcutaneous bremelanotide is rapidly absorbed (Tmax ~60 min) with an elimination half-life of approximately 2.7 hours and predominantly renal clearance/excretion.
healthy volunteers, phase 1 PK studies
In a small study in men with erectile dysfunction, Melanotan II (the unapproved compound from which bremelanotide was derived) induced erections without sexual stimulation and increased sexual desire.
20 men with psychogenic/organic erectile dysfunction
A phase 1 safety/tolerability study found bremelanotide co-administered with ethanol did not produce clinically significant additive cardiovascular or safety effects beyond either agent alone.
healthy male and female volunteers
Based on: the FDA-approved label.
Checked 2026-09
Approved use. Bremelanotide (Vyleesi) is FDA-approved to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women; it is not approved for men or postmenopausal women.
When consultations open, a licensed clinician in your state will review your health history and prescribe PT-141 (Bremelanotide) only if it’s appropriate for you. A licensed U.S. pharmacy will dispense it.