Mitiglinide

Postprandial blood glucose control in adult patients with type 2 diabetes has always been a key and difficult point in clinical management. As a phenylalanine derivative-based prandial glucose regulator, mitiglinide provides a more accurate solution to this clinical demand. Its mechanism of action is glucose-dependent: it rapidly closes ATP-sensitive potassium channels on the membrane of pancreatic β-cells only when blood glucose rises, promoting physiological insulin secretion. With fast onset and short duration of action, it can not only effectively reduce the postprandial blood glucose peak, but also reduce the risk of hypoglycemia. It is especially suitable for monotherapy in patients with type 2 diabetes who have poor control with diet and exercise, and can also be used in combination with non-insulinotropic hypoglycemic agents such as metformin.

The global market size related to mitiglinide has exceeded USD 1.2 billion, with a compound annual growth rate of approximately 4.8% in the past five years. With the continuous rise in the prevalence of diabetes and the popularization of awareness of postprandial blood glucose management in the domestic market, the growth rate is higher than the global average. In 2023, the market size of mitiglinide preparations reached RMB 230 million, with an annual growth rate of 7.2%. The current competitive landscape is dominated by generic drugs, with the market share of the original research product being less than 15%. More than ten domestic enterprises have obtained production approvals for mitiglinide preparations, and the localization rate of active pharmaceutical ingredients (APIs) has exceeded 85%. After winning the bid in the centralized procurement, the terminal price has dropped by 62%, further improving clinical accessibility.

The original research enterprise of mitiglinide is Japan's Kissei Pharmaceutical Co., Ltd., and the original brand name is "Glufast". The core compound patent expired in Japan in 2008, and the compound patent in China expired in 2009. The main dosage form approved for the original research product is tablet, with specifications of 5mg and 10mg. The original research tablet has been included in the Catalogue of Reference Preparations of Chemical Drugs in China. In terms of domestic API registration, as of now, mitiglinide APIs from 13 enterprises have obtained CDE registration numbers, among which 8 have been converted to "A" status. More than 20 mitiglinide tablet and capsule preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for mitiglinide API, which can cover the needs of the whole process of R&D declaration, quality research and release testing. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable support for quality control in the R&D and production links of enterprises.