PT-141
Bremelanotide — melanocortin receptor agonist. FDA-approved as Vyleesi for acquired generalized HSDD in premenopausal women. The only FDA-approved peptide for sexual dysfunction, with Phase III RECONNECT trial data.
PT-141 (bremelanotide) is a synthetic peptide that acts as an agonist at melanocortin receptors MC3R and MC4R in the central nervous system, which play roles in regulating sexual motivation and arousal. It was originally developed as a sunless tanning agent (from melanotan II research) before its sexual effects were identified in clinical study participants.
FDA approved bremelanotide in 2019 under the brand name Vyleesi for the treatment of acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The approval was based on the Phase III RECONNECT trials, which demonstrated statistically significant improvements in sexual desire and reductions in distress versus placebo.
The approved formulation is a prefilled autoinjector (1.75 mg) administered subcutaneously as needed, at least 45 minutes before anticipated sexual activity. Maximum one dose per 24 hours and 8 doses per month are specified in the label. Research-vial use and off-label use in other populations are not established in Phase III trials.
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Bremelanotide has Phase III safety data. Most common: nausea (40%), flushing, headache, injection site reactions. Transient blood pressure increases — contraindicated with certain cardiovascular conditions. Nausea is the most common discontinuation reason. Research-vial use is off-label with no established safety trials for that formulation.