Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company incorporated in 2002, focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases, such as primary biliary cirrhosis (PBC) now called primary biliary cholangitis, non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary sclerosing cholangitis and also the intestinal disorder, bile acid diarrhea.
Products
The company's lead product is Ocaliva (obeticholic acid, OCA), also known as 6-ethyl-chenodeoxycholic acid or INT-747. OCA is a potent first-in-class farnesoid X receptor (FXR) agonist. In 2016, the U.S. Food and Drug Administration (FDA) approved Ocaliva for use in primary biliary cholangitis.[3]
In June 2024, the European Medicines Agency (EMA) recommended revoking the conditional marketing authorization for Ocaliva. The decision followed a review by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the benefits of Ocaliva no longer outweigh its risks. The European Commission officially revoked Ocaliva's marketing authorization on August 30, 2024.[4]