Golexanolone is under clinical development by Umecrine Cognition and currently in Phase II for Idiopathic Hypersomnia (IH). According to GlobalData, Phase II drugs for Idiopathic Hypersomnia (IH) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Golexanolone LoA Report. Buy the report here.
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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.
Golexanolone overview
Golexanolone (GR-3027) (CVXL-0060) is under development for the treatment of hepatic encephalopathy in patients with liver disease, primary biliary cholangitis and idiopathic hypersomnia. The drug candidate is administered orally. It is a small molecule which acts by targeting GABA-A receptor.
Umecrine Cognition overview
Umecrine Cognition, a subsidiary of Umecrine AB, is a drug development company that develops treatments for neurological disorders in the central nervous system. The company develops pharmaceuticals for the treatment of acute life-threatening hepatic encephalopathy (HE) and long-term maintenance in minimal HE caused due to endogenous CNS-active steroids. Its GABA-steroids have been described in various clinical conditions which include hepatic encephalopathy, Alzheimer’s disease and down syndrome. Umecrine Cognition develops and commercializes novel therapeutics to treat hepatic encephalopathy. The company serves patients with cirrhosis in the US. Umecrine is headquartered in Stockholm, Sweden.
For a complete picture of Golexanolone’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
