FDA Approved Sexual & Reproductive Health

PT-141

also known as: Bremelanotide, Vyleesi, PT141

An FDA-approved melanocortin agonist for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

A 7-amino-acid cyclic lactam peptide analog of α-melanocyte-stimulating hormone (α-MSH), acting primarily through central melanocortin-4 receptor activation to influence sexual arousal pathways.

Mechanism of action

Agonist at melanocortin receptors, with greatest affinity for MC4R and MC3R. Activation of central MC4R pathways in the hypothalamus and limbic system modulates sexual arousal and desire. Unlike PDE5 inhibitors (which act on peripheral vascular tissue), PT-141 acts centrally on the neural circuitry of arousal — which also explains why side effects include nausea, flushing, and transient blood pressure increase.

Primary uses

Hypoactive sexual desire disorder (premenopausal women) — FDA approved
Erectile dysfunction (off-label)
Sexual arousal disorders (off-label in both sexes)

Typical dosing

1.75 mg as needed, ≥45 min before anticipated sexual activity (subcutaneous)

FDA-labeled dose. Maximum 1 dose per 24 hours and 8 doses per month. Contraindicated in uncontrolled hypertension and known cardiovascular disease.

Regulatory status

FDA-approved as Vyleesi (bremelanotide) in 2019 for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Manufactured by Palatin Technologies.

References

[fda-pi] Vyleesi (bremelanotide) Prescribing Information. Palatin Technologies.
[clinical-trial] Kingsberg SA, et al. "Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder (RECONNECT trials)." Obstet Gynecol, 2019;134:899-908.
[review] Clayton AH, et al. "Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial." Womens Health, 2016;12:325-337.

Related peptides

Melanotan II

An unapproved cyclic heptapeptide melanocortin agonist marketed for tanning and sexual function — strongly associated with melanocytic changes and dysplastic nevi in case reports. Not recommended.

Afamelanotide

An FDA-approved selective MC1R agonist marketed as Scenesse — the first-in-class treatment for erythropoietic protoporphyria (EPP), delivered as a subdermal implant.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.