Ipragliflozin

The continuous rise in the global prevalence of diabetes has promoted SGLT2 inhibitor drugs to become an important choice for clinical hypoglycemic regimens, and ipragliflozin is one of the representative varieties of this class of drugs. Its mechanism of action does not depend on insulin secretion. By selectively inhibiting sodium-glucose cotransporter 2, it reduces the reabsorption of glucose by the kidneys and increases urinary glucose excretion, thereby lowering blood glucose levels. It is mainly used clinically for monotherapy of type 2 diabetes mellitus or in combination with other hypoglycemic drugs. Meanwhile, studies have shown that it also has additional benefits such as reducing body weight and lowering the risk of cardiovascular events, and is suitable for the group of type 2 diabetes patients with obesity and high cardiovascular risk factors.

At present, the global market size of SGLT2 inhibitors has exceeded 10 billion US dollars. As a mature variety in this category, ipragliflozin has a particularly outstanding performance in the East Asian market, among which the combined market share in Japan and South Korea is close to 70% of the global sales of this variety. In terms of the Chinese market, with the upgrading of the drug use structure for patients with type 2 diabetes mellitus, the overall annual growth rate of SGLT2 inhibitors remains above 20%. Ipragliflozin is currently in a hot stage of generic drug development, and no domestic generic drug has been approved yet. There will be broad substitution space after the patent expires in the future.

The original research enterprise of ipragliflozin is Astellas Pharma Inc. of Japan, with the trade name Suglat. Its core compound patent will expire in China in 2028. The main dosage form approved for the original research drug is tablet, with specifications of 12.5mg and 25mg. It has been included in the reference preparation catalogs of the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the U.S. Food and Drug Administration (FDA), and the China National Medical Products Administration (NMPA) has not yet included the reference preparation of this variety. At present, there is no ipragliflozin preparation approved for marketing in China, and no enterprise has completed the registration with the Center for Drug Evaluation (CDE) and obtained the A-status registration number at the API level. A number of pharmaceutical enterprises are in the stage of registration and declaration. (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 ipragliflozin API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of drug research and development, quality control, registration and declaration.