Repaglinide

Postprandial hyperglycemia is an independent risk factor for the increased risk of cardiovascular events in patients with type 2 diabetes mellitus, and there has been a long-term urgent clinical need for hypoglycemic regimens that can accurately match postprandial blood glucose fluctuations and have a lower risk of hypoglycemia. Repaglinide is a non-sulfonylurea insulin secretagogue. It stimulates the early-phase secretion of insulin by closing the ATP-dependent potassium channels on the membrane of pancreatic β cells. It takes effect 15 to 30 minutes after administration, has a short duration of action, and can effectively simulate physiological insulin secretion. It is mainly used for patients with type 2 diabetes mellitus whose hyperglycemia cannot be effectively controlled by diet control, weight reduction and exercise, especially suitable for elderly patients and people with mainly elevated postprandial blood glucose, and is an important option for current individualized diabetes treatment.

The total number of patients with type 2 diabetes mellitus in China exceeds 140 million, among whom nearly half have poor control of postprandial blood glucose, which drives the continuous and stable market demand for repaglinide. At present, the annual sales of this variety at the terminal of domestic public medical institutions are about 1.2 billion yuan. With the improvement of the coverage of primary diabetes diagnosis and treatment, the market size still maintains an annual growth rate of about 3%. In terms of the competitive landscape, the original research product still accounts for about 40% of the market share. More than 20 domestic enterprises have had their generic drugs approved for marketing, among which 7 enterprises have their preparation products passed the consistency evaluation. Since it was included in the national centralized procurement in 2017, the terminal price has dropped by more than 90%, and its accessibility has been greatly improved.

The original research enterprise of repaglinide is Novo Nordisk, and the original research trade name is "NovoNorm". Its core compound patent expired in China in 2017. The main dosage form approved for the original research is tablet, with specifications including 0.5mg, 1mg and 2mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, there are currently 19 repaglinide API registration numbers including those of the original research manufacturer and domestic manufacturers, among which 15 are in the status of "A" and can be legally supplied for preparation production; there are 27 repaglinide tablet preparation approval numbers in China, which meet the clinical market supply demand. (Data as of July 2025, please refer to the official website of CDE for the latest information)

In response to the research and development and quality control needs of repaglinide, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support enterprises in API quality research, preparation stability study and registration and declaration work.