PT-141 Compound

REFERENCES / THE RECORD

PT-141 references: the sources behind every cited claim.

Every quantitative statement in this digest of PT-141 (bremelanotide) maps to one of these sources — peer-reviewed studies, the FDA prescribing information, and the NIH LiverTox monograph, with DOIs and PubMed links.

Back to the researchRead the FAQ

How to read this list

Each entry below corresponds to a bracketed marker — [1], [2], and so on — used throughout the site. Peer-reviewed journal articles carry a DOI and a PubMed (PMID) or trial (NCT) identifier where one exists. The FDA prescribing information is cited via DailyMed, the official structured-product-label source. Conference abstracts and the corporate press release are labeled as such and are weighted as lower-tier evidence in the body copy — used only for development-status and clinic-context statements, never as pivotal results.

The approved-indication evidence (RECONNECT and the 52-week extension), the mechanistic neuroimaging study, the foundational pharmacology, and the FDA label are the load-bearing sources. The early male-erectile PK/PD papers and the 2024-2025 items are cited for the off-label and pipeline sections, with their not-approved status flagged in the prose.

  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. U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information. 2019. ↗
  7. 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. ↗
  8. 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. ↗
  9. 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. ↗
  10. Dooley AB, Houssaini AS, Tsai T, Ramasamy R. Use of Telemedicine for Sexual Medicine Patients. Sex Med Rev. 2020;8(4):507-517. ↗
  11. National Institute of Diabetes and Digestive and Kidney Diseases. Bremelanotide — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. NCBI Bookshelf. 2021. [Also the reference for the documented controversies: modest effect-size critiques (Spielmans 2021, 2024), hyperpigmentation via MC1R, the HPG-axis misconception, the appetite-pathway dosing note, the 2023 Expression of Concern on the 2008 ED study, and the research-chemical status.] ↗
  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;269:110299. ↗
  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.) ↗
  14. Palatin Technologies, Inc. Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction (ED). Corporate press release. 2024. ↗
  15. National Institute of Diabetes and Digestive and Kidney Diseases. Bremelanotide — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury (hepatic safety, serum enzyme elevations, and metabolism). NCBI Bookshelf. 2021. ↗