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Dorzagliatin: First Approval.

Yahiya Y Syed¹

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

|November 30, 2022

Summary

This summary is machine-generated.

Dorzagliatin, a glucokinase activator, is approved in China for type 2 diabetes. It improves blood sugar control by activating glucokinase in a glucose-dependent manner, offering a new treatment option.

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Area of Science:

Pharmacology
Endocrinology
Metabolic Diseases

Background:

Dorzagliatin (HuaTangNing) is an oral glucokinase activator developed for type 2 diabetes mellitus (T2DM), type 1 diabetes mellitus (T1DM), and diabetic kidney disease (DKD).
Glucokinase activation improves glycemic control by modulating glucose metabolism in a glucose-dependent manner.

Purpose of the Study:

To summarize the key development milestones of dorzagliatin.
To highlight the drug's journey leading to its first regulatory approval.

Main Methods:

Review of preclinical and clinical development data.
Analysis of regulatory submission and approval process in China.

Main Results:

Dorzagliatin demonstrated efficacy in improving glycemic control in adult patients with T2DM.
Approval in China in September 2022 for monotherapy and add-on to metformin treatment.
The drug activates pancreatic and hepatic glucokinase in a glucose-dependent manner.

Conclusions:

Dorzagliatin represents a novel therapeutic approach for T2DM management.
The drug's approval signifies a significant advancement in diabetes treatment.
Further development for T1DM and DKD is ongoing.