Jump to content
Shop PT-141

Desire, skin, and the record behind the claims.

PT-141 reading list: trials, labels and laboratory work

The clinical record, the laboratory record and the older detours have different things to offer.

Approved use and label restrictions

The prescribing information sets out the approved indication, labelled amount, blood-pressure restrictions and pigmentation warning. The first-approval review provides the regulatory and development context. I give those sources priority when the question is what was approved, rather than what was once investigated.

For measured clinical outcomes, the RECONNECT trial paper and open-label extension belong together. One provides the placebo comparison; the other provides longer observation and the published adverse-event rates. The pharmacotherapy review adds a more cautious appraisal of efficacy and reporting.

The less convenient exhibits

The female-rat study concerns solicitation. The female Syrian hamster study concerns sexual reward. The human imaging experiment concerns desire and brain processing in a small group of women. Reading them as if they all tested “better sex” would flatten their most useful differences.

The 2008 male salvage study remains listed with its 2023 Expression of Concern. I would not promote its disputed result to the same standing as an unchallenged clinical estimate. The notice is an essential part of its record.

History and material identification

The melanocortin history and early PT-141 development profile explain the tanning origins and nasal-spray ambitions. They help account for the name’s reputation without extending today’s approval.

The forensic sample analysis documents laboratory findings. The related-peptide toxicity case concerns melanotan II, not PT-141 itself. That distinction matters even though the compounds share a history. The list below contains the full source entries, including structural studies, safety reviews and the other contextual papers used here.

  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. Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. Int J Impot Res. 2004;16(1):51-59. ↗
  9. Rosen RC, Diamond LE, Earle DC, Shadiack AM, Molinoff PB. Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to sildenafil. Int J Impot Res. 2004;16(2):135-142. ↗
  10. 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. ↗
  11. 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. ↗
  12. 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: 2023 Expression of Concern issued.] ↗
  13. Zhang H, Chen LN, Yang D, Mao C, Shen Q, Feng W, et al. Structural insights into ligand recognition and activation of the melanocortin-4 receptor. Cell Res. 2021. ↗
  14. Tran L, Nguyen TD, Gad AG, Shaaban E, Tai TH, Tram NT. FDA-Approved Drugs Containing D-Amino Acids: A Historical and Developmental Perspective. Drug Dev Res. 2026. ↗
  15. Barakeh D, Mdaihly H, Karaoui LR. Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal Women. Ann Pharmacother. 2025. ↗
  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. ↗