Melanocortin receptor agonist · FDA-approved (women only)

PT-141 (Bremelanotide)

Approved (women)FDA-approved for low sexual desire in premenopausal women, but use in men is off-label with much thinner controlled evidence.

A brain-acting peptide that stimulates sexual desire and arousal through melanocortin receptors, FDA-approved for women but not for men.

✦ 2 min read · 2 sources

What it is

Bremelanotide is a synthetic melanocortin peptide approved by the FDA in June 2019 under the brand Vyleesi for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is explicitly not indicated for men or for postmenopausal women. It was derived from melanotan II, originally a tanning peptide.

How it works

Unlike erectile-dysfunction drugs that increase genital blood flow, bremelanotide works centrally by activating melanocortin receptors (chiefly MC4R, with some MC3R) in brain regions including the hypothalamus. This stimulates neural pathways involved in sexual desire and arousal rather than acting directly on blood vessels.

What the evidence shows

FDA approval rested on two Phase 3 RECONNECT trials enrolling over 1,200 premenopausal women with HSDD, where a 1.75 mg subcutaneous dose improved desire and reduced distress versus placebo. Evidence in men is far more limited, drawn largely from earlier erectile-function and small exploratory studies rather than large modern trials. Nausea is the dominant side effect, reported in roughly 40% of users on first injection.

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The honest take

FDA-approved for low sexual desire in premenopausal women, but use in men is off-label with much thinner controlled evidence.

Status & safety

Vyleesi is a prescription product approved only for premenopausal women; any use in men is off-label and not FDA-evaluated, and research-grade 'PT-141' sold outside that channel is not approved for human use. Common adverse effects include nausea, flushing, headache, and injection-site reactions, and the label notes transient blood-pressure increases. Anyone considering it should consult a clinician about appropriateness and risks.

Summaries of published, third-party research for educational purposes. Not medical advice; not a claim of efficacy or safety for any use.

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