Ertugliflozin

In the long-term management of type 2 diabetes, SGLT2 inhibitors have become a core treatment category with both cardiac and renal benefits, relying on their unique insulin-independent glucose excretion mechanism. As the latest generation member of this class of drugs, ertugliflozin selectively inhibits sodium-glucose cotransporter 2 in the renal proximal tubule, reduces the reabsorption of glucose in primary urine, and excretes excess sugar with urine, thereby lowering blood glucose levels. It is clinically indicated for adult patients with type 2 diabetes, and can be used as monotherapy or in combination with other hypoglycemic agents on the basis of diet and exercise, especially suitable for high-risk groups with concomitant cardiovascular diseases or chronic kidney diseases. It can assist in lowering blood pressure and reducing body weight while lowering blood glucose, with outstanding clinical value.

The global market size related to ertugliflozin had exceeded USD 1.3 billion in 2023, with a compound annual growth rate of 18.2% in the past three years. The growth momentum mainly comes from the rising prevalence of diabetes and the continuous expansion of indications for SGLT2 inhibitors. The domestic market is in a rapid introduction period. After being included in the National Medical Insurance Catalog in 2021, its sales volume has increased significantly. At present, the original research product occupies the main market share, and 3 domestic enterprises have submitted marketing applications for generic drugs. As the patent expiration approaches, the competition in the generic market will gradually intensify in the next 2-3 years, and the corresponding demand for compliant supply of active pharmaceutical ingredients will continue to rise.

The original research enterprise of ertugliflozin is Merck Sharp & Dohme, and the original research trade name is Steglatro®. Its core compound patent expires in 2031 in the United States and in 2028 in China. The marketed original research dosage form is tablet, with specifications of 5mg and 15mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (6th Batch)* of China. In terms of domestic API registration, there are currently 5 registration numbers for ertugliflozin API, among which 3 are in status A (approved for use in marketed preparations). The original research preparation and generic preparations from multiple enterprises have been approved for marketing by the National Medical Products Administration. (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 ertugliflozin, most of which are in stock. Orders placed before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and generic drug consistency evaluation.