Bremelanotide
Also called PT-141, Vyleesi.
Bremelanotide has FDA-approved products for specific uses. This page cites 1 source, and the strongest evidence comes from human trials.
- Status
- FDA-approved product exists
- Form
- Pen injection
- Half-life
- Not modeled
- Strongest evidence
- Human trials
- Cited claims
- 1
- Last updated
- November 6, 2026
What the evidence says
Each claim names the kind of study behind it, what it can't tell you, and where it comes from.
Human trials
Two randomized RECONNECT trials found that as-needed subcutaneous bremelanotide improved sexual-desire scores and reduced related distress compared with placebo in premenopausal women with hypoactive sexual desire disorder.
Limits: The 24-week studies evaluated selected patients and a specific formulation. Changes in the number of satisfying sexual events did not differ significantly from placebo. Nausea and other adverse effects affected tolerability.
Regulatory status
United States
Vyleesi is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder causing distress or interpersonal difficulty, excluding medication effects, relationship problems, and coexisting medical or psychiatric causes. Approval covers the subcutaneous autoinjector product. It does not cover male sexual dysfunction or sexual-performance enhancement.