Tenapanor

Chronic kidney disease, a chronic disease with high incidence globally, is often accompanied by hyperphosphatemia as a complication as the disease progresses in patients. Long-term disorders of calcium and phosphorus metabolism can induce severe adverse outcomes such as vascular calcification and cardiovascular events. Tenapanor belongs to a new class of selective sodium-dependent phosphate cotransporter 2b (NPT2b) inhibitors. Its mechanism of action is different from that of traditional phosphate binders: it can directly block the absorption of phosphate from food by inhibiting the activity of NPT2b receptors on the surface of intestinal epithelial cells, without the need to bind with phosphorus in the gastrointestinal tract, which reduces the risk of gastrointestinal adverse reactions. Clinically, it is mainly used for the treatment of hyperphosphatemia in adult dialysis patients with chronic kidney disease, providing a new treatment option for patients who are intolerant to traditional phosphate binders.

Currently, the global market size of therapeutic drugs for hyperphosphatemia has exceeded 5 billion US dollars. With the continuous rise in the prevalence of chronic kidney disease, it is expected to maintain a compound annual growth rate of 6.2% in the next five years. As a category with a brand-new mechanism of action, NPT2b inhibitors have a significantly higher market growth rate than traditional phosphate binders. At present, this细分 track is still in the early stage of development, with only a small number of enterprises having completed the layout of related products. As the first NPT2b class of hyperphosphatemia therapeutic drug approved for marketing, tenapanor has clear clinical differentiation advantages, and its market penetration rate is in the stage of rapid increase.

The original research enterprise of tenapanor is Shionogi & Co., Ltd. of Japan, and the original brand name is NoRPhos. Its core compound patent in Japan will expire in 2033, and the compound patent in China is expected to expire in 2034. The main dosage form approved for the original research product is oral tablet, with two specifications of 10mg and 20mg. At present, the original research preparation has not been approved for marketing in China, and there is no publicly available information on the inclusion of reference preparations. There is no marketed tenapanor registration number in Class A status that can be used for drug production in the API registration database of China CDE. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of tenapanor impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the regulatory requirements of the Chinese Pharmacopoeia and the FDA, and can fully meet the reference standard use needs in the whole process of drug research and development, quality research, production testing, etc.