Alogliptin

In the field of diabetes treatment, DPP-4 inhibitors have become one of the core choices for second-line hypoglycemic therapy due to their clinical advantages of stable hypoglycemic effect, low risk of hypoglycemia, and no impact on body weight. As a highly selective DPP-4 inhibitor, alogliptin reversibly binds to the active site of dipeptidyl peptidase-4 to prolong the physiological action time of endogenous GLP-1 and GIP, promotes insulin secretion and inhibits glucagon release in a glucose-dependent manner. It is indicated for monotherapy or combination therapy with metformin and thiazolidinediones in patients with type 2 diabetes mellitus, and is especially suitable for elderly diabetic patients and those with concomitant cardiovascular diseases.

In recent years, the global market size of DPP-4 inhibitors has stabilized above USD 13 billion. As a mainstream variety of this class of drugs, alogliptin accounts for approximately 7% of the market share. In 2023, the terminal sales of alogliptin in the domestic market exceeded RMB 1.2 billion, with an annual growth rate maintained at around 12%. In terms of competitive landscape, the original research product still accounts for nearly 40% of the market share. A total of 12 domestic enterprises have obtained approval for generic alogliptin, among which 6 enterprises have their preparation products included in the national centralized procurement, with the maximum price reduction of the winning bids exceeding 90% compared with the original research product. As the penetration rate of generic drugs continues to increase, the market demand for high-quality active pharmaceutical ingredients is continuously rising.

The original research enterprise of alogliptin is Takeda Pharmaceutical of Japan, with the original research brand name "Nesina". The core compound patent of alogliptin expires in the United States in 2024, and the Chinese compound patent expired in 2021. The main dosage form approved by the original research is tablet, with specifications including 6.25 mg, 12.5 mg and 25 mg. The original research tablet has been included in the Catalogue of Marketed Drugs in China as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, 13 enterprises have obtained CDE registration numbers for alogliptin APIs as of now, among which 8 are in status "A" and can be used for associated domestic preparation declaration. At present, 23 domestic enterprises have obtained approval for the marketing of alogliptin tablets. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and production needs of alogliptin, CATO provides a full set of impurity reference standards for this API, with most products available from stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable impurity reference standard support for pharmaceutical enterprises in quality research, consistency evaluation and commercial production.