Obeticholic Acid API

Name	Obeticholic Acid
Chinese name	奥贝胆酸
Cas Number	459789-99-2
Source	India
Qualifications	USDMF/-/-/-/-

Obeticholic Acid (Obeticholic Acid) is a farnesoid X receptor agonist. It is a new generation of primary biliary cirrhosis (PBC) treatment drug developed by Intercept Pharmaceuticals in the United States. It was approved by the FDA in May 2016. For the treatment of primary biliary cirrhosis, it was approved for marketing by the European Union in December of the same year. It was the first drug approved for the treatment of PBC in the past 20 years. In 2019, obeticholic acid sales were US$250 million. Intercept's application for a new indication for the treatment of non-alcoholic steatohepatitis (NASH) for obeticholic acid submitted by Intercept has obtained FDA priority review and is in clinical phase III. Obeticholic acid was certified as an orphan drug by the European Medicines Agency's Orphan Medicine Committee (COMP) in 2010. Ursodeoxycholic acid (UDCA) is the only drug previously approved for the treatment of PBC, which can reduce bilirubin and liver enzymes in the blood, improve the condition and increase the survival rate. But ursodeoxycholic acid cannot cure PBC, and half of the patients do not respond or benefit little after using the drug, so these patients urgently need new treatment drugs.

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