Bremelanotide acetate is under clinical development by Palatin Technologies and currently in Phase II for Diabetic Nephropathy. According to GlobalData, Phase II drugs for Diabetic Nephropathy have a 29% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Bremelanotide acetate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Bremelanotide acetate overview

Bremelanotide acetate (Vyleesi) is belongs to class of organic compounds known as oligopeptides. It is formulated as solution for subcutaneous route of administration. Vyleesi is indicated for the treatment of  premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD),  characterized by low sexual desire that causes marked distress or interpersonal difficulty.

Bremelanotide acetate is under development for diabetic kidney disease, premenopausal women with hypoactive sexual desire disorder, impaired female sexual desire. It was under development as a intranasal formulation for the treatment of female sexual dysfunction and erectile dysfunction. It is a self administered subcutaneous auto-injector. The drug candidate is a synthetic peptide analog of alpha-melanocyte stimulating hormone (a-MSH) which acts by targeting melanocortin 4 receptor. It is developed based on MIDAS (Metal Ion-induced Distinctive Array of Structures) drug discovery platform.

Palatin Technologies overview

Palatin Technologies (Palatin) is a biopharmaceutical company that develops receptor specific peptide therapeutics. The company’s medicines are based on molecules that control the activity of the melanocortin and natriuretic peptide receptor systems. Its lead product includes Vyleesi, indicated for the treatment of premenopausal women with hypoactive sexual desire disorder. Palatin clinical pipeline includes melanocortin receptor programs such as PL-8177 MC1r Agonist (oral) for inflammatory bowel disease; PL9643 MCr Agonist for dry eye diseases; PL-8177 MC1r Agonist (systemic) for Covid-19 infection; and MC4r Agonist for diabetic retinopathy. Its natriuretic peptide receptor programs include PL-3994 NPR-A for heart failure and PL-5028 NPR-A/C Agonist for heart failure and fibrosis. Palatin is headquartered in Cranbury, New Jersey, the US.

For a complete picture of Bremelanotide acetate’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.