Imeglimin

In the clinical treatment of patients with type 2 diabetes, new drugs that take both hypoglycemic efficacy and safety into account have always been the core direction of clinical demand. Imeglimin is a first-in-class mitochondria-targeted oral hypoglycemic agent. It improves insulin resistance by regulating mitochondrial function, while promoting physiological insulin secretion and inhibiting hepatic gluconeogenesis. The triple mechanism of action synergistically realizes the regulation of blood glucose homeostasis. It can be used as a monotherapy for adult patients with type 2 diabetes who have poor control with diet and exercise, and can also be used in combination with commonly used hypoglycemic agents such as metformin and insulin. It is especially suitable for patients with metabolic syndrome and partially preserved islet function, and will not increase the risk of hypoglycemia and weight gain.

The current global market size related to imeglimin is showing a rapid expansion trend. In 2023, the overall market size has exceeded 230 million US dollars, with a compound annual growth rate of more than 32%. As the first hypoglycemic agent with a new mechanism of action approved in Japan, its market penetration rate in East Asia has increased particularly significantly. At present, there is no originator or generic preparation of this drug on the market in China, which is a potential blue ocean market for hypoglycemic agents. A number of domestic pharmaceutical companies have started the R&D and declaration of related generic drugs. In the future, with the expansion of indications and the popularization of clinical application consensus, the market space is expected to be further expanded.

The originator enterprise of imeglimine is Japan's Tanabe Mitsubishi Pharma Co., Ltd., and the originator brand name is Twymeeg. Its core compound patent will expire in Japan in 2032, and the compound patent in China is expected to expire in 2031. The main dosage form approved for the originator product is oral tablet, with two specifications of 500mg and 1000mg. It has been included in the medical insurance drug catalogue of the Ministry of Health, Labour and Welfare of Japan, and its reference preparation information has been included in the Orange Book by the FDA. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has not received the marketing application of the originator preparation of imeglimine, nor has there been any public announcement of the registration number of related active pharmaceutical ingredients, and no preparation of this variety has been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO currently provides a full set of impurity reference standards for imeglimine. Most of the products are in stock. For in-stock products, orders placed before 16:00 can 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 have complete technical parameters such as impurity structure confirmation and purity calibration, which can fully meet the full-process needs of pharmaceutical companies in the R&D, quality research and declaration stages of imeglimine active pharmaceutical ingredients.