Bexagliflozin

The global prevalence of diabetes continues to rise. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have become a research and development hotspot in the field of hypoglycemia in recent years due to their unique insulin-independent glucose excretion mechanism. As a representative member of SGLT2 inhibitors, bexagliflozin can specifically inhibit the SGLT2 receptor in the proximal convoluted tubule of the kidney, reduce glucose reabsorption, and achieve blood glucose control by excreting excess sugar through urine. It is mainly used clinically to improve the blood glucose level of patients with type 2 diabetes. It can be used as monotherapy, or in combination with metformin, sulfonylureas or insulin, providing more treatment options for adult patients with type 2 diabetes whose blood glucose is poorly controlled by diet and exercise.

At present, the global market size of SGLT2 inhibitors has exceeded 15 billion US dollars, with a compound annual growth rate of about 8%. As a new generation of SGLT2 inhibitors, bexagliflozin has a particularly prominent growth rate in the East Asian market due to its lower risk of adverse urinary tract infection reactions. The R&D of generic drugs in China is highly popular, and nearly 10 enterprises have submitted clinical applications for bexagliflozin preparations. As the centralized procurement policy gradually covers hypoglycemic drugs, the supply of active pharmaceutical ingredients (APIs) with controllable cost and compliant quality has become one of the core competitiveness of enterprises in this track.

The original research enterprise of bexagliflozin is Hanmi Pharmaceutical Co., Ltd. from South Korea, with the original brand name of Suganon. The expiration time of its core compound patent in China is 2028. The main dosage form approved for the original drug is tablet, with specifications of 5mg and 10mg, which has been included in the China Listed Drug Catalogue as the reference listed drug. Up to now, one domestic enterprise's bexagliflozin API has obtained the CDE registration number (status A), and 2 generic bexagliflozin preparations produced by domestic enterprises have been approved for marketing. (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 bexagliflozin, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable material basis support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation.