The PT-141 reading shelf
The original papers are more particular, and often more interesting, than their reputation.
The label, RECONNECT and follow-up
The US prescribing information sets out the indication, amount, route and safety restrictions. The RECONNECT trial report and its open-label extension are different sorts of evidence: a randomized placebo comparison followed by longer observation. The approval-era clinical review offers another way into the same clinical record.
Early development and mechanism studies
For the origin, there is Hadley and Dorr’s history of melanocortin therapeutics and the nasal-spray development profile. The female-rat solicitation study, human brain-imaging experiment and female Syrian hamster reward experiment make a useful sequence precisely because they do not all measure the same thing.
Safety and unregulated-product sources
The blood-pressure monitoring study, development-programme safety analysis and LiverTox monograph sit beside the efficacy papers. The forensic product analysis and melanotan-II toxicity case concern supply and a related compound; they are not interchangeable with a bremelanotide clinical trial. The conference abstracts listed below also retain their preliminary status.
- 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. ↗
- 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. ↗
- 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. ↗
- 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. ↗
- 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. ↗
- 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. ↗
- U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information. DailyMed (US FDA structured product label). 2019. ↗
- Hedlund P. PT-141 Palatin. Curr Opin Investig Drugs. 2004. ↗
- Al Shaer D, Al Musaimi O, Albericio F, de la Torre BG. 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals (Basel). 2020;13(3):40. ↗
- Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019;79:1599-1606. ↗
- 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. ↗
- Mayer D, Lynch SE. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder. Ann Pharmacother. 2020;54(7):684-690. ↗
- Goldstein I, et al. (122) Positive Effects of Bremelanotide on Female Sexual Arousal and Orgasm in Premenopausal Women [conference abstract]. J Sex Med. 2025. ↗
- Vereecken S, et al. (396) Comparative Analysis of Flibanserin, Bremelanotide, and Testosterone Therapy for Female Sexual Dysfunction [conference abstract]. J Sex Med. 2025. ↗
- 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. ↗
- 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. ↗
- 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. ↗
- 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. ↗
- 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. ↗
- Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical toxicology (Philadelphia, Pa.). 2012. ↗
- 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. ↗
- 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. ↗
- Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006. ↗