Setmelanotide hydrochloride ER is under clinical development by Rhythm Pharmaceuticals and currently in Phase III for Obesity. According to GlobalData, Phase III drugs for Obesity have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Setmelanotide hydrochloride ER’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.

Setmelanotide hydrochloride ER overview

Setmelanotide hydrochloride extended release formulation (CAM-4072) is under development for the treatment of genetic obesity including Bardet-Biedl syndrome (BBS). It is administered subcutaneously. The drug candidate is a peptide that acts by targeting the melanocortin 4 receptor (MC4R). it is developed based on FluidCrystal technology. The drug candidate is an extended release formulation.

Rhythm Pharmaceuticals overview

Rhythm Pharmaceuticals is a biopharmaceutical company. It develops and commercializes drugs to treat rare genetic disorders of obesity due to POMC, PCSK1, or LEPR deficiency. The company offers IMCIVREE (setmelanotide), a melanocortin-4 receptor (MC4R) agonist injection for chronic weight management in adults and pediatric patients. The company is advancing RM-853, a ghrelin O-acyltransferase (GOAT) inhibitor targeting Prader-Willi syndrome (PWS). It is also evaluating setmelanotide against bardet-biedl syndrome. The company offers its products in Israel, China, Hong Kong and Macau. Rhythm Pharma is headquartered in Boston, Massachusetts, the US.

For a complete picture of Setmelanotide hydrochloride ER’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.