Chenodeoxycholic Acid

Cholelithiasis is a digestive system disease with high clinical incidence. Traditional surgical treatment has a high risk of trauma, and oral litholytic drugs provide a non-invasive intervention option for patients with cholesterol gallstones. Chenodeoxycholic acid is a bile acid derivative. As a natural component of endogenous bile acids, it can inhibit cholesterol synthase, reduce cholesterol secretion in bile, and lower the reabsorption efficiency of bile acids, so as to gradually dissolve cholesterol stones. It can also be used for adjuvant treatment of cholestatic liver disease and hyperlipidemia, especially suitable for cholelithiasis patients who cannot tolerate surgery or refuse surgery. It is the world's first oral drug approved for gallstone litholytic treatment.

The global market size of chenodeoxycholic acid was approximately USD 420 million in 2023, with a compound annual growth rate maintained at around 5.8%. The growth momentum mainly comes from the expansion of the scale of patients with chronic liver diseases and the rising demand for choleretic veterinary drugs in the livestock and poultry breeding field. In the domestic market, generic drugs account for more than 90%, and the main production areas of API are concentrated in Sichuan-Chongqing and Jiangsu-Zhejiang regions. Affected by the tightening of the supply chain of biochemical APIs since 2021, the average ex-factory price has increased by about 12% in the past three years. At present, 17 oral preparation enterprises have passed the consistency evaluation, and the winning bid price in centralized procurement is 68% lower than that of the original research drug, which significantly improves the accessibility of drugs for patients.

The original research enterprise of chenodeoxycholic acid is Allergan plc (USA), with the original brand name Chenodal. Its core compound patent in the United States expired in 1993, and there is no registration information of compound patent in China. The main dosage form of the original research drug is oral capsule, with specifications of 125mg and 250mg. It has been included in the FDA Orange Book Reference Preparation Catalog, but has not been included in the Chinese Listed Drug Catalog. According to the domestic API registration platform, there are currently 13 API registration numbers for chenodeoxycholic acid, 8 of which are in A status and can support preparation declaration. The domestic approved and marketed chenodeoxycholic acid preparations are mainly capsules, with a total of 21 approval documents. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for chenodeoxycholic acid for industry customers. Most products are in regular stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with clear traceability of impurities and complete structure confirmation data, which can fully meet the needs of the whole process of API R&D, quality research and registration declaration.