Bremelanotide is a melanocortin receptor agonist. The FDA label describes a specific approved indication for premenopausal women with acquired, generalised hypoactive sexual desire disorder; it is not labelled as a general sexual-performance treatment.

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Bremelanotide is a synthetic melanocortin-receptor agonist, a cyclic heptapeptide analogue of alpha-MSH. Unlike melanotan II it is comparatively selective, with activity principally at MC4R and MC1R. Its labelled action on sexual desire is central rather than vascular - it does not work like a PDE5 inhibitor.

Terminal half-life of 2.7 hours after a single subcutaneous dose, range 1.9 to 4.0 hours, per the Vyleesi prescribing information. Given as needed rather than daily.

FDA-approved in June 2019 as Vyleesi for acquired, generalised hypoactive sexual desire disorder in premenopausal women, on the basis of two randomised placebo-controlled 24-week trials. This is an approved indication with a defined population - it is not labelled for men, for postmenopausal women, or for general libido enhancement, and the label states it should be discontinued after eight weeks if no improvement is seen.

Labelled adverse reactions include nausea (about 40% of treated patients, most commonly with the first dose), flushing, injection-site reactions, headache and vomiting. Transient increases in blood pressure and decreases in heart rate occur after each dose, and it is contraindicated in uncontrolled hypertension or known cardiovascular disease. Focal hyperpigmentation including of the face, gingiva and breasts has been reported, more often with daily dosing than the labelled as-needed use.

This summary reflects a U.S. product label and not an individual recommendation. Contraindications, warnings, interactions, and product availability must be checked in the current local label and with a qualified clinician.