Vildagliptin

The number of patients with type 2 diabetes mellitus worldwide continues to rise, and there is always an urgent clinical demand for oral hypoglycemic drugs that balance safety and compliance. Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor class of hypoglycemic drugs. By specifically inhibiting the activity of DPP-4 to reduce the degradation of glucagon-like peptide-1 (GLP-1), it can regulate the secretion of insulin and glucagon in a glucose-dependent manner, and has a very low risk of hypoglycemia when used alone. It can be used as monotherapy for adult patients with type 2 diabetes mellitus who have poor control after diet and exercise, and can also be used in combination with metformin, insulin and other drugs, especially suitable for elderly diabetic patients and those with combined renal impairment.

According to public data, the overall market size of domestic DPP-4 inhibitors has exceeded 7 billion yuan in recent years. As a widely used variety among them, vildagliptin accounts for a stable market share of about 18%. With the inclusion of this variety in the national centralized drug procurement, the price of the selected generic drugs has dropped by more than 90%, and the clinical accessibility has been greatly improved. The annual growth rate of the overall market consumption has remained above 25%. At present, more than 30 domestic enterprises have been approved to produce vildagliptin preparations, and the process of domestic substitution of APIs continues to accelerate.

The original research enterprise of vildagliptin is Novartis Pharmaceuticals, and the original research trade name is "Galvus". The expiration date of its core compound patent in Europe and the United States is 2019, and the expiration date of the Chinese patent is 2022. The main dosage form of the original research that has been marketed is tablet, with specifications of 50mg and 100mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA Reference Preparation Catalogue. Up to now, more than 20 domestic enterprises have completed the registration (status A) of vildagliptin APIs in CDE, and more than 60 vildagliptin single-agent and compound 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 can provide a full set of impurity reference standards for vildagliptin, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D and production needs of API and preparation enterprises such as quality research, stability study, and declaration and registration.