PT-141 Legit

REFERENCES / 17 PRIMARY SOURCES

PT-141 References and Citations.

The complete numbered citation list — peer-reviewed journal articles, the FDA Vyleesi prescribing information, the DailyMed structured product label, the NIDDK LiverTox monograph, and the independent skeptical re-analysis.

Primary literature

PT-141 references and citations follow, numbered as they appear in body text across this digest. Every quantitative claim on the site resolves to one of the 17 sources below. The list mixes peer-reviewed primary literature, regulatory documents (FDA label, DailyMed structured product label), an NIDDK monograph, and a published independent re-analysis. See the per-entry DOI, PubMed, or accessdata.fda.gov link for the source document.

  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, Giuliano F, Gelez H. Bremelanotide: An Overview of Preclinical CNS Effects on Female Sexual Function. J Sex Med. 2007;4 Suppl 4:269-279. ↗
  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 (RECONNECT). Obstet Gynecol. 2019;134(5):899-908. ↗
  4. U.S. Food and Drug Administration / Palatin Technologies. VYLEESI (bremelanotide injection) Prescribing Information — FDA approval package, NDA 210557. ↗
  5. Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health. 2022;31(2):171-182. ↗
  6. 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. ↗
  7. U.S. National Library of Medicine / FDA / Palatin Technologies. VYLEESI (bremelanotide injection) — DailyMed structured product label. ↗
  8. Simon JA, Kingsberg SA, Portman D, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med. 2019;16(8):1198-1206. ↗
  9. 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. ↗
  10. Pfaus JG, 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(27):10201-10204. ↗
  11. Pfaus J, Giuliano F, Gelez H. Bremelanotide: An Overview of Preclinical CNS Effects on Female Sexual Function. J Sex Med. 2007;4 Suppl 4:269-279. ↗
  12. Dhillon S, Keam SJ. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women. CNS Spectr. 2022;27(3):281-289. ↗
  13. U.S. Food and Drug Administration / Palatin Technologies. VYLEESI (bremelanotide injection) Prescribing Information — Section 6 Adverse Reactions. ↗
  14. Spielmans GI. Re-Analyzing Phase III Bremelanotide Trials for 'Hypoactive Sexual Desire Disorder' in Women. J Sex Res. 2021;58(9):1085-1094. ↗
  15. National Institute of Diabetes and Digestive and Kidney Diseases. Bremelanotide — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. NCBI Bookshelf; updated 2021. ↗
  16. 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. ↗
  17. Thurston L, Hunjan T, Ertl N, Wall MB, Mills EG, Suladze S, Patel B, Alexander EC, Muzi B, Bassett PA, Rabiner EA, Bech P, Goldmeier D, Abbara A, Comninos AN, Dhillo WS. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022;132(19):e152341. ↗
  18. Kingsberg SA, Clayton AH, Portman D, Krop J, Jordan R, Lucas J, Simon JA. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. J Womens Health. 2022;31(4):455-466. ↗
  19. Shadiack A, Althof S, Spana C, et al. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. J Am Soc Hypertens. 2017 (PMC archived). ↗