PT-141

PT-141, known by its generic name bremelanotide, is a synthetic cyclic heptapeptide derived from Melanotan II. It acts as an agonist at melanocortin receptors MC3R and MC4R in the central nervous system, distinguishing it from vascular-acting medications. Bremelanotide was developed by Palatin Technologies and refined from Melanotan II specifically to target sexual arousal pathways while minimizing broader melanocortin effects like skin pigmentation.

In 2019, the FDA approved bremelanotide under the brand name Vyleesi for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This made it the first melanocortin receptor agonist approved for a sexual health indication and the first FDA-approved on-demand treatment specifically targeting sexual desire rather than vascular function.

Bremelanotide's development spanned more than two decades. Early research examined intranasal formulations in both male erectile dysfunction and female sexual dysfunction, but the intranasal route was halted by the FDA in 2007 due to observed increases in blood pressure. Development subsequently shifted to subcutaneous injection, which demonstrated a more favorable cardiovascular profile.

Phase 3 clinical trials evaluated bremelanotide in premenopausal women with acquired, generalized HSDD and demonstrated improvements in sexual desire and reductions in associated distress compared to placebo. The medication is administered via subcutaneous autoinjector approximately 45 minutes before anticipated sexual activity. Research has also explored its potential in male sexual dysfunction, though it is not currently FDA-approved for men. Off-label use in men has been reported in clinical practice.