Elobixibat

Cholestatic liver diseases, primary biliary cholangitis and other diseases have long been faced with the clinical pain points of limited treatment options and poor long-term prognosis of patients. As the world's first oral selective ileal bile acid transporter (IBAT) inhibitor, elobixibat inhibits the function of ileal apical IBAT to reduce the reabsorption of bile acids in the intestinal tract and lower the systemic bile acid load, thereby improving cholestasis-related liver injury. At present, this drug has been approved for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged 1 year and older, and it is the first targeted therapeutic drug in this rare disease field. Meanwhile, clinical studies for other cholestatic liver diseases such as biliary atresia and Alagille syndrome are also progressing steadily.

As a blockbuster variety in the orphan drug field, the global market size of elobixibat has exceeded USD 180 million in 2023, with a compound annual growth rate of over 45%. The core growth drivers come from the successive approval of rare disease indications in various regions around the world and the improvement of patient diagnosis rate. At present, the global market is still dominated by the original research enterprise, and a small number of generic drug enterprises around the world have launched bioequivalence studies, while no generic drug has been approved for marketing in China. With the improvement of domestic security policies for rare disease drugs, the market penetration rate of this drug still has large room for improvement.

The original research enterprise of elobixibat is Mirum Pharmaceuticals from the UK, with the brand name Livmarli. The core compound patent will expire in 2036 in the EU region, and the core patent in the US will expire in 2038. At present, the main dosage form approved by the original research is oral solution, with the specification of 60ml:75mg. The original dosage form has been included in the FDA Reference Listed Drug Catalogue. No elobixibat preparation has been approved for marketing in China, and no elobixibat API registration number with A status has been found on the CDE API registration platform for the time being. (Data as of June 2025, please refer to the official CDE website for the latest information)

If you are carrying out relevant R&D or quality research work on this API, CATO can provide a full set of elobixibat impurity reference standards. Most of the products are available from stock. For stock orders placed before 16:00, they can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of registration declaration and quality control research.