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Research documentation · References

PT-141 References and Citations

Every quantitative claim on this site maps to one of these sources — the published bremelanotide literature, the FDA structured product label, and the 2025 research.

About these PT-141 references

These PT-141 references are the complete cited basis for this digest. They include the foundational mechanism pharmacology (Molinoff 2003; Pfaus 2004), the pivotal Phase 3 RECONNECT program and its 52-week extension (Kingsberg 2019; Simon 2019), the US FDA structured product label via DailyMed, the first-approval review (Dhillon 2019), the human fMRI mechanism study (Thurston 2022), the dose-finding and responder analyses, the program-level safety and patient-experience literature, and the 2025 hamster mechanism and review papers. Each numbered entry corresponds to the inline [N] markers throughout the site. Citations are provided with DOIs and PubMed, ClinicalTrials.gov, or DailyMed URLs so any claim can be traced to its source.

  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. U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information (structured product label). 2019.
  6. Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019;79:1599-1606.
  7. Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, Harning R. An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT-141), a Melanocortin Receptor Agonist. J Sex Med. 2006;3(4):628-638.
  8. Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, et al. Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial. Womens Health (Lond). 2016;12(3):325-337.
  9. Althof S, Derogatis LR, Greenberg S, Clayton AH, Jordan R, Lucas J, Spana C. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med. 2019;16(8):1226-1235.
  10. 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.
  11. Koochaki P, Revicki D, Wilson H, Pokrzywinski R, Jordan R, Lucas J, Williams LA. The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder. J Womens Health (Larchmt). 2021;30(4):587-595.
  12. 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.
  13. 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.
  14. 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.
  15. How A, Simon JA. Novel Pharmacologic Treatments of Female Sexual Dysfunction. Clin Obstet Gynecol. 2025.
  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. 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.
  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.