PT-141, also called bremelanotide, is a lab-made peptide that acts on the brain. The FDA approved it in 2019 as Vyleesi for low sexual desire in women who have not reached menopause. That is its only approved use.
Why scientists study it
- It raises sexual arousal through melanocortin receptors in the brain, not by widening blood vessels, so it works differently from PDE5 inhibitors.
- It grew out of Melanotan 2 research and was picked because it acts mainly in the brain and darkens skin less.
- The FDA approved it in 2019 as Vyleesi for hypoactive sexual desire disorder in women before menopause, and for nothing else.
Three studies to know
2019 · Obstet Gynecol
Kingsberg and colleagues ran RECONNECT, the main Phase 3 trial. It showed the drug worked for HSDD in women before menopause, and the Vyleesi approval rests on it. Read the paper
2004 · Int J Impot Res
Diamond and colleagues tested a nasal spray in healthy men and in men with erectile dysfunction. The study was double-blind and used a placebo. At higher doses, the spray led to more erections than placebo. Flushing and nausea were the most common side effects. Read the paper
2004 · PNAS
Pfaus and colleagues tested in animals how switching on MC3R and MC4R changes sexual behavior. The human trials were built on this work. Read the paper
Safety and legal status
- The approved use is narrow: HSDD in women before menopause. The label rules it out for people with uncontrolled high blood pressure or heart and blood vessel disease. Nausea and reactions at the shot site are common.
- The FDA approved it as Vyleesi in 2019. The MHRA has not approved it, and the EMA application was withdrawn in 2019. It is not currently on the World Anti-Doping Agency list.
- Outside that approval, it is for laboratory research use.
Related compounds
- Kisspeptin: Brain signal that starts the puberty and fertility hormone chain, tested in small human trials.
- Melanotan 2: Lab-made copy of a skin-darkening hormone. Never approved, with reports of harm in users.
- Selank: Lab-made chain of seven amino acids, approved in Russia as a nasal spray for anxiety.
