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PT-141 Pharmacy

A calm, plain-spoken field notebook on PT-141 (bremelanotide) — what the trials actually measured, how the central melanocortin mechanism differs from blood-flow drugs, and where the side-effect and approval lines really sit.

Papers you can read · 07

PT-141 papers show both the measured benefits and the remaining doubts

Developers' tests led to women's limited approval. A men's study from 2008 has questioned results following a warning from the journal in 2023; short meeting reports also leave gaps.

Go back to the explained findingsRead the women’s side-effect results

Large studies offer firmer evidence than brief reports or a disputed study

The developers' tests of desire led to larger studies, follow-up, and brain scans. The Phase 3 papers, the 52-week follow-up, and approved medicine instructions appear below. A number beside a finding leads to its paper; the long library codes identify the exact paper or study.

Meeting reports from 2024-2025 are shorter than full papers checked by other researchers. A 2008 study claimed help after sildenafil failed, but a journal warning in 2023 disputes the findings. You need that warning alongside the claimed benefit when considering the men's results.

  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. (NCT02333071) ↗
  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. (NCT02333071) ↗
  5. Thurston L, Hunjan T, Mills EG, et al. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022;132(19):e152341. (NCT04179734) ↗
  6. U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information. 2019. ↗
  7. Diamond LE, Earle DC, Garcia WD, Spana C. Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction results in an enhanced erectile response. Urology. 2005;65(4):755-759. ↗
  8. Shadiack AM, Sharma SD, Earle DC, Spana C, Hallam TJ. Melanocortins in the Treatment of Male and Female Sexual Dysfunction. Curr Top Med Chem. 2007;7(11):1137-1144. ↗
  9. Safarinejad MR, Hosseini SY. Salvage of Sildenafil Failures With Bremelanotide: A Randomized, Double-Blind, Placebo Controlled Study. J Urol. 2008;179(3):1066-1071. NOTE: An Expression of Concern was published in 2023 (J Urol; PMID 36626345); treat this study's findings as disputed. ↗
  10. 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. ↗
  11. Mayer D, Lynch SE. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder. Ann Pharmacother. 2020;54(7):684-690. ↗
  12. 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. ↗
  13. Goldstein I, et al. (227) Use of the CNS Agent Bremelanotide in Men with Sexual Dysfunction: Results from a Sexual Medicine Clinic. J Sex Med. 2024. [Conference abstract — lower evidence tier than peer-reviewed full text.] ↗
  14. Goldstein I, et al. (122) Positive Effects of Bremelanotide on Female Sexual Arousal and Orgasm in Premenopausal Women. J Sex Med. 2025. [Conference abstract — lower evidence tier than peer-reviewed full text.] ↗
  15. Vereecken S, et al. (396) Comparative Analysis of Flibanserin, Bremelanotide, and Testosterone Therapy for Female Sexual Dysfunction. J Sex Med. 2025. [Conference abstract — lower evidence tier than peer-reviewed full text.] ↗
  16. Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019;79:1599-1606. ↗
  17. 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. ↗
  18. 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. ↗
  19. 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. ↗
  20. 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. ↗
  21. 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. ↗
  22. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical toxicology (Philadelphia, Pa.). 2012. ↗
  23. 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. ↗
  24. 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. ↗
  25. Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006. ↗
  26. Hedlund P. PT-141 Palatin. Current opinion in investigational drugs (London, England : 2000). 2004. ↗
  27. Al Shaer D, Al Musaimi O, Albericio F, de la Torre BG. 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals (Basel, Switzerland). 2020. ↗