PT-141
Bremelanotide / Vyleesi
FDA-approved peptide for sexual dysfunction. Works through central nervous system desire circuits — not vascular mechanisms like PDE5 inhibitors. Effective for both men and women.
Mechanism of action
Melanocortin receptor agonist targeting MC3R and MC4R receptors in the hypothalamus. Activates desire and arousal circuits in the central nervous system. Unlike Viagra and Cialis which work on blood vessels, PT-141 works on the brain circuits that generate sexual desire itself.
Effects in the body
PT-141 is the only approved drug that targets the brain's desire circuitry directly. Every other sexual dysfunction treatment works peripherally on blood vessels. This central mechanism means it can be effective even when vascular-based treatments have failed.
Pros & cons (from the literature)
- FDA-approved as Vyleesi — highest regulatory standing
- Effective for both men and women — unique in this category
- Works through central mechanism independent of vascular health
- Effective when PDE5 inhibitors have failed
- Strong Phase III clinical trial data from FDA approval process
- Nausea occurs in more than 50% of users — most common side effect
- Transient blood pressure increase observed
- Injection or nasal spray required — no oral form available
- Not appropriate for cardiovascular disease patients without physician clearance
- Expensive as branded Vyleesi — compounded versions much more affordable
Protocol summary (from published research)
Dosing ranges reproduced from published research literature. Not a prescription, not medical advice.
FDA & regulatory status
Evidence base
Phase III FDA approval trials completed with robust efficacy data. Strong clinical data for HSDD in premenopausal women. Off-label male use data accumulating in clinical practice.
Primary research sources
Peer-reviewed literature referenced throughout this profile is drawn from PubMed, Cell Metabolism, and clinical trial registries cited in the evidence base above.