PT-141

An FDA-approved melanocortin-4 receptor agonist for hypoactive sexual desire disorder (HSDD) in premenopausal women, acting centrally on the brain rather than peripherally.

Also known as: Bremelanotide, Vyleesi

Regulatory Status

FDA-Approved

Classification date: 2019-06-21

Compounding: Not currently available for compounding

Evidence Summary

Strong15 human studies published

Key Studies

How It Works

PT-141 (bremelanotide) is a cyclic heptapeptide derived from Melanotan II with greater selectivity for the MC4R receptor. Unlike PDE5 inhibitors that act on blood vessels, PT-141 activates melanocortin-4 receptors in the CNS, specifically in hypothalamic regions controlling sexual arousal and desire. This central mechanism of action means it addresses desire (libido) rather than just mechanical function. It was FDA-approved in 2019 as Vyleesi for HSDD in premenopausal women, administered as a subcutaneous injection.

Common Applications

Hypoactive sexual desire disorder in women (FDA-approved as Vyleesi)Sexual dysfunction unresponsive to PDE5 inhibitorsLibido enhancement

Safety & Considerations

Common side effects include nausea (40% of patients), flushing, headache, and injection-site reactions. May cause transient hypertension; blood pressure should be monitored. Contraindicated in uncontrolled hypertension. Can cause skin hyperpigmentation with repeated use. Limited to 8 doses per month per FDA labeling. Not recommended for use with naltrexone due to reduced efficacy.

Regulatory classifications can change rapidly. The information shown here was last verified on 2019-06-21. Always confirm current legal status with a licensed provider or the FDA before making treatment decisions.