CH.04 / BIBLIOGRAPHY
the full citation list
Every quantitative claim on every page of this dossier links to one of these primary sources. Pivotal trials, FDA approval documents, preclinical mechanism papers, and active registry entries — organized in the order they are first cited.
About this list
Every citation below is a primary or first-line source: a peer-reviewed paper, an FDA label document, or an active ClinicalTrials.gov registry entry. All identifiers (DOI, PMID, NCT) are included where available; URLs link to the publisher's or registry's page of record.
This dossier does not link to secondary aggregators, encyclopedia summaries, or unsourced commentary. If a claim on any page cannot be tied to one of these references, treat the claim as editorial framing only and discount it accordingly.
The bibliography
The full reference list is rendered below as a numbered bibliography. Identifiers and links are included with each entry.
- U.S. Food and Drug Administration. Bremelanotide injection — Prescribing Information (NDA 210557). 2019. (Compound identity, indication, structural and receptor pharmacology.) ↗
- Pfaus J, Giuliano F, Gelez H, et al. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women. CNS Spectrums. 2022;27(3):281-289. ↗
- 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. Proceedings of the National Academy of Sciences USA. 2004;101(27):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. Obstetrics & Gynecology. 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. Obstetrics & Gynecology. 2019;134(5):909-917. ↗
- Simon JA, Kingsberg SA, Portman D, Jordan R, Lucas J, Sadiq A, Krop J, Clayton AH. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. Journal of Women's Health. 2022;31(3):391-400. ↗
- 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. International Journal of Impotence Research. 2004;16(1):51-59. ↗
- 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 PDE5 inhibitor therapy. International Journal of Impotence Research. 2004;16(2):135-142. ↗
- Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB. Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and a PDE5 inhibitor to men with erectile dysfunction results in an enhanced erectile response. Urology. 2005;65(4):752-756. ↗
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial. Women's Health (London). 2016;12(3):325-337. ↗
- Pfaus J, Giuliano F, Gelez H. Bremelanotide: An Overview of Preclinical CNS Effects on Female Sexual Function. Journal of Sexual Medicine. 2007;4 Suppl 4:269-279. ↗
- Pfaus J, Giuliano F, Gelez H, et al. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women (mechanistic review). CNS Spectrums. 2022;27(3):281-289. ↗
- 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. Journal of Women's Health. 2022;31(2):171-182. ↗
- U.S. Food and Drug Administration. Bremelanotide injection — Prescribing Information (NDA 210557), pharmacokinetics and dosage sections. 2019. ↗
- U.S. Food and Drug Administration. Bremelanotide injection — Prescribing Information (NDA 210557), Sections 4 and 5.1 (contraindications and cardiovascular pharmacodynamics). 2019. ↗
- U.S. Food and Drug Administration. Bremelanotide injection — Prescribing Information (NDA 210557), Sections 4 and 7 (drug interaction with oral naltrexone). 2019. ↗
- Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms in breast cancer patients on endocrine therapies. Expert Review of Clinical Pharmacology. 2025;18(10). ↗
- Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5 inhibitor for the Treatment of Erectile Dysfunction. Sponsor press release. 2024. ↗
- Single Dose of Bremelanotide in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk. ClinicalTrials.gov registry, NCT06867835. 2024. ↗
- Safarinejad MR, Hosseini SY. Salvage of PDE5-inhibitor failures with bremelanotide: a randomized, double-blind, placebo-controlled study. Journal of Urology. 2008;179(3):1066-1071. ↗
- National Institute of Diabetes and Digestive and Kidney Diseases. Bremelanotide — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2021. ↗
- Spana C, Jordan R, Fischkoff S. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clinical Therapeutics. 2017;39(8):1652-1667. ↗
- Thurston L, Hunjan T, Mills EG, et al. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022;132(19):e152341. ↗
- U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information (NDA 210557). DailyMed. 2019. ↗
- 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. ↗
- Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019;79:1599-1606. ↗
- White WB, Myers MG, Jordan R, Lucas J. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. J Hypertens. 2017;35:977-984. ↗
- 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 Test Anal. 2021;13:33245851. ↗
- Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila). 2012;50:1058-1061. ↗
- 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;24:35170192. ↗
- 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. ↗