Synthetic peptide that acts in the brain on melanocortin receptors. It is approved in the US for hypoactive sexual desire in premenopausal women; it is injected only when sexual activity is planned.
Regulatory status
Approved (FDA / EMA)
Family
Melanocortin receptor agonist
Scientific evidence
Moderate
Number of findings
1
Where it acts
Sexual and reproductive · Brain and sleep
Also known as
PT-141, Vyleesi, bremelanotide
Regulatory status
FDA (U.S.): Approved (2019, Vyleesi) for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
EMA (EU): Not approved (no marketing authorization in the EU).
Dose
1.75 mg by subcutaneous injection at least 45 minutes before sexual activity; maximum 1 dose in 24 h and 8 doses per month (FDA label, Vyleesi 2019).
Safety
The most common effects are nausea (very common, especially with the first dose), flushing, headache, and injection-site reactions. It transiently raises blood pressure and slightly lowers heart rate: it is contraindicated with uncontrolled hypertension or known cardiovascular disease. It can darken the skin (focal hyperpigmentation), more so with frequent use. Only with a prescription and medical supervision.
Interactions
It slows gastric emptying and may reduce the absorption of oral drugs; avoid with oral naltrexone (it may lose efficacy). Caution with drugs that raise blood pressure.
Differences between women and men
Approved only in premenopausal women; it is not approved in men or in postmenopausal women. The phase 3 trials (RECONNECT) included only premenopausal women. It must be stopped if pregnancy occurs. View the study →
Effect by goal · level of evidence
Hypoactive sexual desire in premenopausal women
improvesModerateRCT (AA)in people
+0.35 pts desire
Two phase 3 trials (RECONNECT) with 1,267 women over 24 weeks. Compared with placebo, it modestly improved the desire score (+0.35 points on the FSFI scale) and reduced the associated distress (−0.33). The effect is statistically clear but small in size. Nausea, flushing, and headache were more frequent than with placebo.
It is an analog of the hormone alpha-MSH. It acts mainly on the melanocortin 4 receptor (MC4R) in areas of the brain that regulate sexual desire. It does not act on genital blood flow the way erectile dysfunction drugs do.
What the evidence says
In people
Hypoactive sexual desire in premenopausal women. Two phase 3 trials (RECONNECT) with 1,267 women over 24 weeks. Compared with placebo, it modestly improved the desire score (+0.35 points on the FSFI scale) and lowered the associated distress (−0.33). The effect is statistically clear but small in size. Nausea, flushing and headache were more frequent than with placebo. PubMed 31599840