Obeticholic Acid

Primary biliary cholangitis is a chronic progressive autoimmune liver disease. Without effective intervention, it will gradually progress to liver fibrosis, cirrhosis and even liver failure, and there has been a long-term lack of targeted treatment options in clinical practice. Obeticholic acid, as a farnesoid X receptor (FXR) agonist class of active pharmaceutical ingredient (API) for liver disease treatment, inhibits bile acid synthesis, promotes bile acid excretion by activating the FXR pathway, and alleviates liver inflammation and fibrosis progression. It is currently the only drug approved globally for the treatment of adult patients with primary biliary cholangitis who have an inadequate response to or are intolerant of ursodeoxycholic acid. It can also be used in combination with ursodeoxycholic acid for the patient population with unsatisfactory response to conventional treatment, providing a core option for patients with end-stage liver disease to delay disease progression.

The global obeticholic acid-related market size exceeded USD 620 million in 2023, and the compound annual growth rate from 2025 to 2030 is expected to remain at 11.7%. The main growth drivers come from the clinical advancement of non-alcoholic steatohepatitis (NASH) indications and the increase in patient penetration in emerging markets. At present, the global API supply pattern is highly concentrated, with overseas manufacturers accounting for more than 70% of the market share. More than 20 domestic enterprises have submitted marketing applications for generic obeticholic acid. With the expiration of the patent protection period, the cost advantages of domestic API manufacturers will gradually become prominent, and the market share of domestic obeticholic acid APIs is expected to rise to more than 40% by 2027.

The original developer of obeticholic acid is Intercept Pharmaceuticals, a US-based company, with the original brand name Ocaliva. The expiration dates of its core compound patents in the United States and the European Union are October 2022 and November 2023, respectively, and the compound patent in China expired in 2024. The main dosage form approved for the original product is tablet, with specifications of 5mg and 10mg. It has been included in the FDA Reference Listed Drug Catalogue, and is also included in the *Catalogue of Reference Preparations for Chemical Drugs (Fifth Batch)* of China. As of now, obeticholic acid APIs from 18 domestic enterprises have completed registration with the Center for Drug Evaluation (CDE) and obtained Grade A status, and obeticholic acid tablets from more than 10 enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for obeticholic acid API, which can simultaneously meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day, which can fully cover the reference standard requirements in the whole process of API R&D, quality research and registration declaration.