What it is
PT-141 is bremelanotide, a synthetic cyclic heptapeptide and an active metabolite of the melanocortin analogue Melanotan II. It is a non-selective melanocortin receptor agonist with activity at MC1R, MC3R and MC4R. It appears in sexual medicine research, where it has been through two Phase 3 trials in premenopausal women with hypoactive sexual desire disorder.
How it works
Bremelanotide is thought to act centrally, at melanocortin-4 receptors in hypothalamic pathways that regulate sexual desire and arousal. That places its proposed mechanism in the nervous system rather than in vascular smooth muscle, where PDE5 inhibitors act.
Regulatory status
- Cosmetic ingredient
- Research compound
- In clinical trials
- Approved medicine
Approved as a medicine by the FDA or the EMA for at least one indication. Approval covers the named indication and formulation only.
What published research is studying
- Sexual desire and desire-related distress in premenopausal women with hypoactive sexual desire disorder (two Phase 3 trials)
- Durability of response and adverse events across an open-label extension
- Subjective arousal and desire in premenopausal women with female sexual arousal disorder
- Erectile response in men who did not respond to a PDE5 inhibitor
Key findings
Across the two RECONNECT Phase 3 trials in 1,267 premenopausal women with hypoactive sexual desire disorder, desire scores rose 0.30 and 0.42 above placebo over 24 weeks.
Kingsberg SA et al., Obstet Gynecol 2019In the same trials, desire-related distress fell relative to placebo by 0.37 in study 301 (P<.001) and 0.29 in study 302 (P=.005). Nausea, flushing and headache were each reported by 10% or more.
Kingsberg SA et al., Obstet Gynecol 2019In the open-label extension, 684 participants continued and 272 completed it, with change in the Female Sexual Function Index desire domain from baseline ranging from 1.25 to 1.30.
Simon JA et al., Obstet Gynecol 2019In a randomized study of 342 men who had not responded to sildenafil, 33.5% of the bremelanotide group met the response criterion versus 8.5% on placebo (P=0.03).
Safarinejad MR, Hosseini SY, J Urol 2008
What the studies measured
Study durations
- RECONNECT Phase 3 trials: a 4-week qualification period, a 4-week baseline period, then 24 weeks of double-blind treatment (NCT02333071).
- Open-label extension: continued after the 24-week core phase in 684 participants (Simon et al. 2019).
- Female sexual arousal disorder study: a double-blind crossover with laboratory sessions in 18 participants (Diamond et al. 2006).
Endpoints
- Female Sexual Function Index desire domain score
- Female Sexual Distress Scale item on being bothered by low desire
- Erectile-function response rate in the sildenafil non-responder study
- Reported adverse events including nausea and flushing
- Vaginal photoplethysmography response in the arousal study
How strong is the evidence?
Human evidence is substantial for the female desire indication, with two randomised placebo-controlled Phase 3 trials and an open-label extension. Average effect sizes on desire scales were modest.
Common questions
Is PT-141 an approved medicine?
Approved medicine. Approved as a medicine by the FDA or the EMA for at least one indication. Approval covers the named indication and formulation only.
How much human research is there on PT-141?
Human evidence is substantial for the female desire indication, with two randomised placebo-controlled Phase 3 trials and an open-label extension. Average effect sizes on desire scales were modest.
Does UU supply PT-141?
Yes, as premium-grade research material for laboratory use. Every batch is tested by an independent lab and the certificate of analysis is published.