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Medicinal PT-141

A medicine, a benefit, an argument.

PT-141 reading list

The original studies and the objections to them belong within reach of one another.

Trials and re-analysis

Start with the RECONNECT trial report and then the Spielmans re-analysis. The objection about clinical meaning has more force for me when the original findings remain in sight. The open-label extension adds longer follow-up; it answers a different question from the blinded comparison.

Safety sources and historical reviews

The prescribing information provides the approved indication, amount and contraindications. The integrated safety analysis reviews adverse events across development. Historical reviews explain how the molecule reached sexual-function research. The bibliography below includes the wider research on this compound, with papers used for historical context as well as treatment benefit.

I ask different things of an animal experiment, a regulatory label and a critical secondary analysis. They can disagree or qualify one another without becoming interchangeable.

  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. Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019;79:1599-1606. ↗
  7. U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information (structured product label). 2019. ↗
  8. Mayer D, Lynch SE. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder. Ann Pharmacother. 2020;54(7):684-690. ↗
  9. Cipriani S, Maseroli E, Vignozzi L. An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder. Expert Opin Pharmacother. 2023;24(1):15-21. ↗
  10. National Institute of Diabetes and Digestive and Kidney Diseases. Bremelanotide — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2021. ↗
  11. Kim S, Cho MC, Cho SY, Chung H, Rajasekaran MR. Novel Emerging Therapies for Erectile Dysfunction. World J Mens Health. 2021;39(1):48-64. ↗
  12. Spielmans GI. Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. J Sex Res. 2021;58(9):1085-1105. ↗
  13. 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;110299. ↗
  14. Fuhrman J, et al. Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms. Expert Rev Clin Pharmacol. 2025. ↗
  15. Rowen T, et al. Evaluation and management of hypoactive sexual desire disorder in women: Recommendations from a multidisciplinary panel. Sex Med Rev. 2026. ↗
  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. 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. ↗
  20. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical toxicology (Philadelphia, Pa.). 2012. ↗
  21. 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. ↗
  22. 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. ↗
  23. Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006. ↗
  24. Hedlund P. PT-141 Palatin. Current opinion in investigational drugs (London, England : 2000). 2004. ↗
  25. Al Shaer D, Al Musaimi O, Albericio F, de la Torre BG. 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals (Basel, Switzerland). 2020. ↗