Nateglinide

In response to the clinical pain point of poor postprandial blood glucose control in patients with type 2 diabetes, nateglinide, as a D-phenylalanine derivative class of prandial glucose regulator, fills the medication gap of traditional hypoglycemic drugs with its unique mechanism of action. It reversibly blocks ATP-sensitive potassium channels on pancreatic β-cells to rapidly promote insulin secretion, effectively mimicking the physiological insulin secretion pattern, reducing postprandial blood glucose fluctuations while significantly lowering the risk of hypoglycemia. Clinically, it is mainly used for patients with type 2 diabetes whose blood glucose cannot be effectively controlled by diet and exercise therapy. It can be used alone or in combination with non-sulfonylurea hypoglycemic drugs such as metformin, and is especially suitable for elderly patients and patient populations mainly presenting with elevated postprandial blood glucose.

The global nateglinide market size has maintained a compound annual growth rate of 3.2% in recent years, with the market size reaching approximately USD 180 million in 2023, among which the Asia-Pacific region accounts for more than 45% and is the fastest growing regional market. In the domestic market, more than 10 enterprises have been approved to produce nateglinide preparations at present. After the centralized procurement, the price of nateglinide tablets has dropped by more than 70%, and the clinical accessibility has been greatly improved, driving the continuous rise in demand for upstream APIs. At present, the domestic API supply is dominated by local enterprises, and the competitive landscape is relatively fragmented.

The original research enterprise of nateglinide is Astellas Pharma of Japan, with the original research brand name "Starlix", and its Chinese compound patent expired in 2012. The main dosage form of the original research product is tablet, with specifications of 60mg and 120mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation listed by FDA. Up to now, there are 12 domestic registration numbers of nateglinide APIs, among which 8 are in A status and can be supplied for domestic preparation production, and more than 20 nateglinide preparation varieties have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for nateglinide API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA at the same time, and can provide stable and reliable impurity reference standard support for API manufacturers and preparation R&D enterprises, effectively shortening the R&D cycle and reducing compliance risks.