Microchip's new diabetes drug sitaglipta sodium is approved for listing in China

ArticleMedicine Guanlan

Today, China’s National Food and Drug Administration (NMPA) recently announced that Microchip's Class 1 new drug sitaglipta sodium has been approved for marketing.

Screenshot source: NMPA official website

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease.

According to microchip bios public information, sitaglipta sodium is a configuration-restricted peroxidase proliferator-activated receptor full agonist, which can moderately activate the three receptor subtypes of PPARα, γ and δ, and inhibit it more effectively CDK5 activated by obesity and inflammatory factors phosphorylates PPARγ, thereby selectively changing the expression of a series of genes related to insulin sensitization

According to the NMPA official website, as a new PPAR full agonist, sitaglipta sodium can not only control blood sugar in the treatment of type 2 diabetes, but also treat the lipid and energy metabolism disorders that are usually associated with patients, thereby benefiting the heart.

In July 2021, Microchip issued a press release stating that the journal Science Bulletin published the results of two confirmatory phase 3 clinical trials, which is also the world's first phase 3 PPAR full agonist for the treatment of T2DM Clinical trial report

The combined results of two phase 3 trials showed that after 24 weeks of treatment with sitaglipta sodium, the absolute value of glycosylated hemoglobin (HbA1c) was reduced by 1.

In terms of safety, compared with the placebo and the control group, the two dose groups of sitaglipta sodium are basically consistent in the overall incidence and severity of adverse events

Regarding the two Phase 3 clinical results and their significance, Science Bulletin also published a review article by Professor DeFronzo, Director of the Diabetes Center of the University of Texas in the United States

It is worth mentioning that the research and development of siglita sodium has lasted more than 16 years

references:

[1] The National Food and Drug Administration approved the listing of sitaglipta sodium tablets.

[3] China's original innovative drug sitaglipta sodium-improving insulin resistance and reversing abnormal glucose and lipids.