Obeticholic acid is under clinical development by Intercept Pharmaceuticals and currently in Phase III for Biliary Atresia. According to GlobalData, Phase III drugs for Biliary Atresia does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Obeticholic acid LoA Report. 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.
Obeticholic acid overview
Obeticholic acid (Ocaliva) is a bile acid analouge. It is formulated as tablets and film coated tablets for oral route of administration. Ocaliva is indicated in the treatment of primary biliary cholangitis, also known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Obeticholic acid is under development for the treatment of Biliary Atresia. It is derived from the primary human bile acid chenodeoxycholic acid (CDCA). The drug candidate was under development for the treatment of biliary atresia, type 2 diabetes, portal hypertension and bile acid diarrhea. It was also under development for nonalcoholic steatohepatitis (NASH),liver cirrhosis, alcoholic hepatitis and for primary biliary cirrhosis (PBC) in China .
Intercept Pharmaceuticals overview
Intercept Pharmaceuticals (Intercept), a subsidiary of Alfasigma SpA, is a biopharmaceutical company that researches, develops, and commercializes treatments for non-viral, progressive liver diseases. It develops products using proprietary bile acid chemistry. The company’s lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor. The company is advancing OCA for the treatment of primary biliary cholangitis (PBC) and other liver diseases. The company harnesses its proprietary bile acid chemistry to develop innovative drugs. It is also advancing INT-787, an FXR agonist for the treatment of severe alcohol-associated hepatitis and obeticholic acid (OCA) and bezafibrate for the potential treatment of individuals with PBC. Intercept is headquartered in Morristown, New Jersey, the US.
For a complete picture of Obeticholic acid’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.
