# PT-141 References: Cited Studies & the FDA Label

> PT-141 (bremelanotide) references: the peer-reviewed studies, systematic reviews, and FDA prescribing information cited across this digest, with DOIs, PMIDs, and URLs.

Every study and document cited across this digest, with identifiers for verification.

## How to read this list

Every numbered citation used across this site is listed below with its journal, year, and a DOI, PMID, or URL for verification. The list spans the foundational pharmacology, the preclinical female and negative-control work, the pivotal Phase 3 trials and their long-term extension, the human brain-imaging study, recent systematic reviews, the FDA prescribing information, and the published critiques. One older male-erectile-dysfunction salvage study (Safarinejad & Hosseini, 2008) received a 2023 Expression of Concern and its findings should be treated as disputed; it is noted here for completeness as part of the historical record rather than as supporting evidence.

## References

[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. https://pubmed.ncbi.nlm.nih.gov/12851303/
[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. https://pubmed.ncbi.nlm.nih.gov/15226502/
[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. https://pubmed.ncbi.nlm.nih.gov/31599840/
[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. https://pubmed.ncbi.nlm.nih.gov/31599847/
[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. https://pubmed.ncbi.nlm.nih.gov/36189794/
[6] 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;267:110299. https://pubmed.ncbi.nlm.nih.gov/39793696/
[7] U.S. Food and Drug Administration / DailyMed. Bremelanotide Injection — US Prescribing Information. DailyMed (US FDA structured product label). 2019. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8c9607a2-5b57-4a59-b159-cf196deebdd9
[8] Ronghe V, Pannase K, Gomase KP, Mahakalkar MG. Understanding Hypoactive Sexual Desire Disorder (HSDD) in Women: Etiology, Diagnosis, and Treatment. Cureus. 2023;15(12):e49690. https://pubmed.ncbi.nlm.nih.gov/38161863/
[9] Hedlund P. PT-141 Palatin. Curr Opin Investig Drugs. 2004;5(4):456-462. https://pubmed.ncbi.nlm.nih.gov/15134289/
[10] Kingsberg SA, Clayton AH, Pfaus JG. The Female Sexual Response: Current Models, Neurobiological Underpinnings and Agents Currently Approved or Under Investigation for the Treatment of Hypoactive Sexual Desire Disorder. CNS Drugs. 2015;29(11):915-933. https://pubmed.ncbi.nlm.nih.gov/26519340/
[11] Mintzes B, Tiefer L, Cosgrove L. Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent. Drug Ther Bull. 2021;59(12):185-188. https://pubmed.ncbi.nlm.nih.gov/34642243/
[12] Toledo RG, Winkelman WD, Reyes-Gonzalez D, Bergeron S, Fladger A, Hacker MR. Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options. J Minim Invasive Gynecol. 2026. https://pubmed.ncbi.nlm.nih.gov/40543759/
[13] Ashour AM. Clinical trial evidence on emerging pharmacological therapies for hypoactive sexual desire disorder in women: a systematic review and analysis of completed studies registered on ClinicalTrials.gov. Front Med (Lausanne). 2026;13:1789809. https://pubmed.ncbi.nlm.nih.gov/42254382/
[14] Cocchetti C, Ristori J, Mazzoli F, Vignozzi L, Maggi M, Fisher AD. Management of hypoactive sexual desire disorder in transgender women: a guide for clinicians. Int J Impot Res. 2020. https://pubmed.ncbi.nlm.nih.gov/33558671/
[15] Krupke H, Zoratto N, Rabut L, Gao D, Paunović N, Klein Cerrejon D. A biodegradable suction patch for sustainable transbuccal peptide delivery. J Control Release. 2025;383:113947. https://pubmed.ncbi.nlm.nih.gov/40513668/

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A regulatory-careful reading room on PT-141 (bremelanotide): the single 2019 approval for premenopausal HSDD held distinct from every off-label and research-chemical use, each figure logged to the trials or the FDA label — a reading desk organized around the prescription record, never a place that writes, fills, or fulfils one.