Tucidinostat

The treatment of hyperuricemia associated with chronic kidney disease has long been limited by medication options. Traditional uric acid-lowering drugs are prone to cause adverse reactions such as increased renal function burden, so there is an urgent clinical need for innovative solutions that combine both efficacy and renal safety. Topiroxostat is a new generation of selective xanthine oxidase inhibitor. It reduces uric acid production by specifically inhibiting the activity of xanthine oxidase. Its metabolism does not depend on renal excretion, so there is no need to adjust the dosage according to the patient's renal function. It is mainly used for the treatment of hyperuricemia in patients with chronic kidney disease, including both dialysis and non-dialysis populations, filling the clinical gap in uric acid-lowering treatment for patients with renal insufficiency.

Currently, the global number of patients with hyperuricemia combined with chronic kidney disease exceeds 100 million. Driven by the rising prevalence of kidney diseases and the increasing penetration rate of clinical medication, the market size related to topiroxostat is expected to exceed 1.2 billion US dollars by 2027, with a compound annual growth rate remaining above 18%. In terms of competitive landscape, the original research product still dominates the major global markets. Generic drug enterprises in countries such as China and India have successively launched bioequivalence studies. As the core patents expire one after another, the launch of generic drugs in the future will further promote the improvement of drug accessibility.

The original research enterprise of topiroxostat is Teijin Pharma Limited of Japan, and the original brand name is Topiloric. The expiration dates of its core compound patents in Japan, the United States and Europe are 2026, 2027 and 2028 respectively. The currently approved main dosage form is tablet, with specifications including 20mg and 40mg. The original research product has been included in the reference preparation catalogue of the Pharmaceuticals and Medical Devices Agency of Japan. At present, there is no approved and marketed topiroxostat preparation in China, and no enterprise has submitted the API DMF registration for this variety. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of topiroxostat impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet various reference standard needs of pharmaceutical enterprises in the process of generic drug research and development, quality research and consistency evaluation.