How to read this list
Each inline citation marker [N] on this site links to the corresponding entry below. The list runs in the order the references first appear across the site. Citations include the full author list where practical (or a shortened form for very long lists), the journal, the year, and either a DOI or a stable URL — typically PubMed, PMC, the journal's article page, or accessdata.fda.gov for the label.
The references span four categories: the RECONNECT pivotal trials and their extensions ([1], [2], [4], [14], [18]); the program-wide safety and pharmacology record ([3], [9], [10], [11], [12]); the mechanism and neuroimaging work ([5], [6], [16]); and the historical and ongoing extension programs in male ED, obesity, oncology, and combination ED ([7], [8], [13], [15], [17], [19]).
The reference list
- [1]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.
- [2]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.
- [3]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.
- [4]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.
- [5]Thurston L, Hunjan T, Mills EG, Wall MB, Ertl N, Phylactou M, Muzi B, Patel B, Alexander EC, Suladze S, Modi M, Eng PC, Bassett PA, Abbara A, Goldmeier D, Comninos AN, Dhillo WS. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. The Journal of Clinical Investigation. 2022.
- [6]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.
- [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. International Journal of Impotence Research. 2004.
- [8]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.
- [9]Bremelanotide injection US Prescribing Information. US FDA Approved Label, NDA 210557. 2019.
- [10]Bremelanotide Prescribing Information: Section 5 Warnings and Precautions. US FDA Approved Label, NDA 210557. 2019.
- [11]Bremelanotide Prescribing Information: Section 5.2 Focal Hyperpigmentation. US FDA Approved Label, NDA 210557. 2019.
- [12]Edinoff AN, Sanders NM, Lewis KB, Apgar TL, Cornett EM, Kaye AM, Kaye AD. Bremelanotide for Treatment of Female Hypoactive Sexual Desire. Neurology International. 2022.
- [13]Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes, Obesity and Metabolism. 2022.
- [14]RECONNECT investigators. Positive Effects of Bremelanotide on Female Sexual Arousal and Orgasm in Premenopausal Women with HSDD: FSFI Data from the RECONNECT Trials. The Journal of Sexual Medicine (Supplement). 2025.
- [15]Suzuki S, Kitanaka C, Okada M. Melanocortin Receptor Agonist Bremelanotide Induces Cell Death and Growth Inhibition in Glioblastoma Cells via Suppression of Survivin Expression. Anticancer Research. 2024.
- [16]Pfaus JG, Sadiq A, Spana C, Clayton AH. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women. CNS Spectrums. 2022.
- [17]Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide (BMT-801). Sponsor press release. 2025.
- [18]Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder (open-label extension enrollment data). Obstetrics & Gynecology. 2019.
- [19]Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019. (Regulatory history review; also covers initiation of the Phase 2 co-administered bremelanotide + PDE5i ED trial, June 2024.)