PT-141 (Bremelanotide)
Vyleesi
FDA-approved melanocortin agonist for low sexual desire in premenopausal women.
Overview
Bremelanotide acts in the brain rather than on blood flow. It is approved for hypoactive sexual desire disorder (HSDD) in premenopausal women and has been studied — but not approved — in men with erectile dysfunction.
Mechanism of action
Agonist at melanocortin-4 (and MC1) receptors in the hypothalamus, modulating dopaminergic pathways involved in sexual desire.
Benefits & evidence ratings
Dosing
Doses show what has been studied or discussed — not guidance. Always follow your prescriber.
| Source | Dose | Frequency | Duration | Route |
|---|---|---|---|---|
Vyleesi label A Established / approved | 1.75 mg | As needed, ≥45 min before activity; max 1 dose/24 h and 8 doses/month | Stop if no improvement after 8 weeks | Subcutaneous autoinjector |
Compounded nasal sprays D Anecdotal / community Earlier intranasal development was dropped partly due to blood-pressure effects. | Varies widely | As needed | — | Intranasal |
Clinical trials & studies
- Phase 32019Bremelanotide for HSDD: Two Randomized Phase 3 Trials (RECONNECT, Obstet Gynecol)
Statistically significant gains in desire score vs placebo.
- LabelCurrentVyleesi prescribing information
Official label.
Safety
Side effects
- Nausea (~40% in trials)
- Flushing, headache
- Transient blood-pressure rise
- Focal hyperpigmentation with repeated use
Contraindications
- Uncontrolled hypertension or cardiovascular disease
Interactions
- Reduces absorption of oral naltrexone — avoid combination
- May slow gastric emptying of oral drugs
Long-term safety
52-week open-label extension showed no new safety signals; hyperpigmentation risk rises with frequent use.
Regulatory status
FDA approved
FDA approved 2019 (Vyleesi) as an autoinjector for premenopausal HSDD only. Nasal sprays are not approved.
FAQ
Commonly discussed alongside
Listing a combination does not mean it has been studied or is safe.