Teneligliptin

Diabetes is a chronic metabolic disease with high incidence worldwide. DPP-4 inhibitors, with both hypoglycemic efficacy and safety, have been one of the mainstream R&D directions in the field of oral hypoglycemic drugs in recent years. Teneligliptin is a highly selective long-acting DPP-4 inhibitor. It reversibly binds to the active site of DPP-4 enzyme to reduce the degradation of glucagon-like peptide-1 (GLP-1), and promotes insulin secretion and inhibits glucagon release in a glucose-dependent manner, so as to achieve stable blood glucose control. It is clinically mainly used for monotherapy or combination therapy of type 2 diabetes, especially suitable for elderly patients and patients with combined renal impairment, and no dose adjustment is required.

The global teneligliptin market size exceeded USD 920 million in 2023, with a compound annual growth rate of 8.7% in the recent three years; the terminal sales in the domestic market were approximately RMB 1.26 billion in 2023, with a growth rate of over 40%. At present, the teneligliptin preparations approved for marketing in China are mainly the original research product and products from 3 domestic generic drug enterprises. This variety has not been included in the centralized drug procurement, so the market is still in a stage of rapid expansion, and the demand for upstream API continues to rise along with the increasing layout of generic drug enterprises.

The original research enterprise of teneligliptin is Japan's Tanabe Mitsubishi Pharma, with the trade name "Tenelia", and its Chinese compound patent expired in February 2024. The main dosage form approved for the original research product is tablet, with a specification of 20 mg per tablet, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)* issued by the National Medical Products Administration. In terms of domestic API registration, as of now, teneligliptin APIs from 6 enterprises have obtained Class A status through CDE registration, and domestic teneligliptin tablets have been approved for marketing by 3 enterprises, which are deemed to have passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of teneligliptin impurity reference standards, covering all impurity types related to the synthesis process and degradation process. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day, which can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of R&D, quality research and production links.