Gliquidone

As a second-generation sulfonylurea oral hypoglycemic drug, gliquidone exerts a mild and long-lasting blood glucose regulation effect by selectively acting on pancreatic β-cells to promote endogenous insulin secretion and improve the sensitivity of peripheral tissues to insulin. Its most prominent clinical feature is that 95% of its metabolites are excreted via the biliary tract, while only 5% are cleared through the kidney, making it the sulfonylurea drug with the lowest renal excretion rate currently available. It is particularly suitable for patients with type 2 diabetes mellitus complicated with mild to moderate renal insufficiency and the elderly diabetic population, as it can significantly reduce the risk of hypoglycemia caused by drug accumulation, and has outstanding advantages in clinical medication safety.

The prevalence of type 2 diabetes mellitus in China has reached 11.2%, among which patients with concurrent renal injury account for more than 30%, and the clinical demand for hypoglycemic drugs with renal safety is continuously increasing. In recent years, the annual sales of gliquidone in sample hospitals have remained stable at around 800 million yuan, and the growth rate in the primary care market has maintained above 7%. In terms of the competitive landscape, the original research product accounts for approximately 60% of the market share, and there are 6 domestic generic manufacturers in total, indicating a relatively high overall market concentration. With the advancement of the hierarchical diagnosis and treatment policy, the expansion space of the primary care medication market continues to be released.

The original research manufacturer of gliquidone is Boehringer Ingelheim, Germany, with the original brand name "Glurenorm". Its core compound patent expired globally in 2008. Currently, the originally researched formulation approved in China is the tablet with a specification of 30mg, which has been included in the China Listed Drug Catalogue and is the reference listed drug (RLD) for this variety. Up to now, there are 7 valid registration numbers of gliquidone API on the CDE API registration platform, among which 3 are in A status and can be used for the associated domestic preparation declaration. A total of 6 domestic enterprises have obtained marketing approval for gliquidone tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for gliquidone API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, fully meeting the full-process R&D needs of pharmaceutical enterprises from generic drug declaration to routine quality control.