Sotagliflozin

Diabetes is a chronic metabolic disease with a high incidence globally, among which patients with type 2 diabetes account for more than 90% and are often accompanied by complications such as chronic kidney disease and cardiovascular diseases. There is an urgent clinical need for treatment regimens that take both glucose lowering and organ benefits into account. Sotagliflozin belongs to the sodium-glucose co-transporter 1/2 (SGLT1/SGLT2) dual inhibitor. By simultaneously inhibiting intestinal SGLT1 to reduce glucose absorption and inhibiting renal SGLT2 to increase urinary glucose excretion, it can achieve stable glucose lowering while improving the cardiovascular and renal outcomes of patients. Currently, its indications cover adult type 2 diabetes, adjuvant treatment of type 1 diabetes, and it can also be used for high-risk populations with chronic kidney disease or cardiovascular diseases, filling the treatment gap of single-target SGLT2 inhibitors in some populations with complications.

The global market size related to sotagliflozin had exceeded USD 470 million in 2023, with a compound annual growth rate of more than 32%. The growth momentum mainly comes from the expansion of treatment demand of the patient group with diabetes complicated by complications. In terms of the competitive landscape, the original research product still occupies the core market share at present. Seven pharmaceutical companies around the world have submitted marketing applications for generic drugs, and no generic drug has been approved in China. Coupled with the smooth clinical progress of its new indication for heart failure, the market is expected to usher in a new round of volume increase in the next 3 to 5 years.

The original research enterprise of sotagliflozin is Lexicon Pharmaceuticals in the United States, and the original research trade name is Zynquista. The core compound patent expires in 2032 in the United States and in 2031 in China. The main approved dosage form is oral tablet, with specifications of 200mg and 400mg. The original research preparation has been included in the FDA Reference Listed Drug Catalog, and has not been included in the Chinese Catalog of Reference Preparations for Chemical Drugs yet. No valid A-status registration number of sotagliflozin has been found on the domestic API registration platform for the time being, and only 2 enterprises have submitted API registration applications which are in the review stage. Currently, no sotagliflozin-related preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for sotagliflozin API, and most products are in stock. Orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.