PT-141
Bremelanotide (melanocortin receptor agonist)
Also known as: Bremelanotide, Vyleesi
An FDA-approved melanocortin agonist for hypoactive sexual desire disorder in premenopausal women.
Overview
PT-141, or bremelanotide, is a melanocortin receptor agonist approved by the FDA as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Unlike vascular treatments, it acts centrally on pathways involved in sexual desire.
Mechanism of action
Agonizes central melanocortin receptors (notably MC4R) involved in sexual arousal and desire pathways.
Key studies & citations
- Human2019
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (RECONNECT)
1,267 premenopausal women across two identical 24-week trials: bremelanotide 1.75 mg as needed significantly increased FSFI desire scores (+0.35 integrated) and reduced desire-related distress versus placebo; nausea, flushing and headache in 10% or more.
Obstetrics & Gynecology - Human2019
Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder
684 women entered the 52-week open-label extension of RECONNECT, providing the long-term safety data behind the approval.
Obstetrics & Gynecology - Review2019
Vyleesi (bremelanotide injection) NDA 210557 approval letter
FDA approval (June 21, 2019) of bremelanotide for premenopausal women with acquired, generalized hypoactive sexual desire disorder.
U.S. Food and Drug Administration
Frequently asked questions
What is PT-141 approved for?
It is FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women. Other uses are off-label or research.