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Reviews PT-141

A skeptical reading of the PT-141 (bremelanotide) evidence — what the trials measured, what they did not.

The literature

PT-141 References

Every figure on this site maps to one of these sources. Primary trials, mechanistic studies, the prescribing information, and the critical re-analyses.

Back to the appraisalSee the trial record

How to read this list

These are the sources behind every quantitative claim on this site, numbered to match the inline citations. The strongest evidence — the two pivotal RCTs, the long-term extension, and the prescribing information — sits alongside mechanistic, preclinical, and review work and the critical re-analyses that complicate the headline. Brand names that appear in a citation title are reproduced verbatim as published; everywhere else this site uses the generic name bremelanotide. Where a source is a review or the regulatory label rather than a primary trial, the appraisal weights it accordingly.

  1. Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY. PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Ann N Y Acad Sci. 2003;994:96-102. ↗
  2. Pfaus J, Shadiack A, Van Soest T, Tse M, Molinoff P. Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist. Proc Natl Acad Sci U S A. 2004;101:10201-10204. ↗
  3. Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899-908. ↗
  4. Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134(5):909-917. ↗
  5. Thurston L, Hunjan T, Mills EG, Wall MB, Ertl N, Phylactou M, et al. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022;132(19):e152341. ↗
  6. Borland JM, Kohut-Jackson AL, Peyla AC, Hall MA, Mermelstein PG, Meisel RL. Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder. Neuropharmacology. 2025;267:110299. ↗
  7. U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information. 2019. ↗
  8. Dooley AB, Houssaini AS, Tsai T, Ramasamy R. Use of Telemedicine for Sexual Medicine Patients. Sex Med Rev. 2020;8(4):507-517. ↗
  9. Weinberger JM, Houman J, Caron AT, Patel DN, Baskin AS, Ackerman AL. Female Sexual Dysfunction and the Placebo Effect: A Meta-analysis. Obstet Gynecol. 2018. ↗
  10. Sauter M, Uhl P, Burhenne J, Haefeli WE. Ultra-sensitive quantification of the therapeutic cyclic peptide bremelanotide utilizing UHPLC-MS/MS for evaluation of its oral plasma pharmacokinetics. J Pharm Biomed Anal. 2020. ↗
  11. Nappi RE, Tiranini L, Cucinella L, Martini E, Bosoni D, Righi A. Pharmacotherapy for female sexual dysfunctions (FSDs): what is on the market and where is this field heading? Expert Opin Pharmacother. 2023. ↗
  12. Croft HA. Understanding the Role of Serotonin in Female Hypoactive Sexual Desire Disorder and Treatment Options. J Sex Med. 2017. ↗
  13. Aughton KL, Hamilton-Smith K, Gupta J, Morton JS, Wayman CP, Jackson VM. Pharmacological profiling of neuropeptides on rabbit vaginal wall and vaginal artery smooth muscle in vitro. Br J Pharmacol. 2008. ↗
  14. Tan R, et al. Telemedicine Use During the COVID-19 Pandemic in 8 Countries From the International Society for Sexual Medicine. J Med Internet Res. 2025. ↗
  15. Dhillon S, Keam SJ. Bremelanotide: First Approval Drugs. 2019;79:1599-1606. ↗
  16. White WB, Myers MG, Jordan R, Lucas J. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide J Hypertens. 2017;35(4):761-768. ↗
  17. Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants Clin Ther. 2017;39(3):514-526.e14. ↗
  18. Clayton AH, Kingsberg SA, Portman D, Sadiq A, Jordan R, Lucas J, Spana C, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program J Womens Health (Larchmt). 2022;31(2):171-182. ↗
  19. National Institute of Diabetes and Digestive and Kidney Diseases (LiverTox). Bremelanotide - LiverTox: Clinical and Research Information on Drug-Induced Liver Injury NCBI Bookshelf (LiverTox). 2021. ↗
  20. Mestria S, Odoardi S, Frison G, Strano Rossi S. LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of performance and image enhancing drugs. Drug testing and analysis. 2021. ↗
  21. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical toxicology (Philadelphia, Pa.). 2012. ↗
  22. Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials Diabetes Obes Metab. 2022;24(6):1084-1093. ↗
  23. Bardhan M, Anand A, Javed A, Chilo MA, Khan N, Garg T. Polymorphism of Melanocortin Receptor Genes-Association with Inflammatory Traits and Diseases. Diseases (Basel, Switzerland). 2025. ↗
  24. Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006. ↗
  25. Hedlund P. PT-141 Palatin. Current opinion in investigational drugs (London, England : 2000). 2004. ↗
  26. Al Shaer D, Al Musaimi O, Albericio F, de la Torre BG. 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals (Basel, Switzerland). 2020. ↗