(Bezafibrate + obeticholic acid) is under clinical development by Intercept Pharmaceuticals and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase III drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how (Bezafibrate + obeticholic acid)’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.
(Bezafibrate + obeticholic acid) overview
Fixed-dose combination of obeticholic acid and bezafibrate is under development for the treatment of primary biliary cholangitis (PBC). Obeticholic acid acts by targeting farnesoid X receptor (FXR) and bezafibrate acts by targeting peroxisome proliferator-activated receptor alpha (PPARA). The drug combination is administered through oral route.
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 (Bezafibrate + obeticholic acid)’s drug-specific PTSR and LoA scores, buy the report here.
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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 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.
