Vildagliptin

With the prevalence of type 2 diabetes mellitus continuing to rise globally, DPP-4 inhibitors that combine hypoglycemic efficacy and safety have become one of the core options for second-line clinical treatment. Vildagliptin is a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor. It competitively binds to the active site of DPP-4, delays the degradation of glucagon-like peptide-1 (GLP-1), promotes insulin secretion and inhibits glucagon release in a glucose-dependent manner, so as to achieve a stable glycemic control effect. It can be used for the treatment of adult type 2 diabetes mellitus either as a monotherapy or in combination with metformin, and is particularly suitable for elderly patients, people at high risk of hypoglycemia and patients with concomitant renal impairment. The incidence rate of gastrointestinal adverse reactions is far lower than that of traditional hypoglycemic drugs.

The global vildagliptin market size has exceeded USD 2.1 billion in 2024, with a compound annual growth rate of 6.2% in the past three years. In terms of the domestic market, as the core patent expired in 2021, more than 30 enterprises have obtained approval for generic drug marketing so far. The sales volume in sample hospitals reached RMB 1.27 billion in 2023, up 47.3% year on year. Among them, the varieties selected in centralized drug procurement have accounted for nearly 80% of the public medical market share. The overall market has gradually shifted from a pattern dominated by original research drugs to a pattern of full competition among generic drugs, and the annual growth rate of demand for upstream API is stable at above 35%.

CATO can provide a full set of impurity reference standards for vildagliptin API. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Their structures are jointly confirmed by multiple methods such as NMR, MS and HPLC, and the impurity traceability data is complete and traceable, which can support the research requirements of the whole process of generic drug consistency evaluation. Conventional specifications are in sufficient stock and can be delivered on the same day, helping pharmaceutical enterprises shorten the R&D and declaration cycle.