Bremelanotide
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Bremelanotide

PT-141 / Vyleesi®
Sexual health
RouteSubcutaneous injection (as needed)
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Mechanism

This one works your brain, not your blood vessels: a melanocortin-4 receptor agonist acting straight on the hypothalamus, the desire switch itself, not the plumbing downstream. That's the whole difference between this and a PDE5 inhibitor. One turns on wanting it, the other just handles the mechanics once you already do.

Key Benefit

FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women. Produces meaningful improvement in desire and distress scores.

Evidence Base

FDA-approved as Vyleesi in 2019, on the strength of the RECONNECT trials. That approval is for women. Men only have phase II data behind them, nothing near what women's got on record.

Route & Rationale

Subcutaneous injection (as needed). Central nervous system target requires systemic delivery. SC provides rapid onset (45 min).

Interactions

Transient blood pressure increase (~3 mmHg) and nausea common. Avoid with uncontrolled hypertension or naltrexone.

Regulatory Status

FDA-approved, specifically for premenopausal women with HSDD. That's the label. That's who it was studied on.

Gender Note

The approval covers premenopausal women only. That's what the FDA signed off on. Men using this for sexual dysfunction are working with phase II data and an off-label prescription, not the approval women get.

Hard Contraindications

Hypertension, Heart failure (CHF), Pregnancy/planning