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Dorzagliatin: First Approval

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Abstract

Dorzagliatin (HuaTangNing) is an oral glucokinase activator that is being developed by Hua Medicine for the treatment of type 2 diabetes mellitus (T2DM), type 1 diabetes mellitus (T1DM) and diabetic kidney disease (DKD). Dorzagliatin improves glycaemic control by activating pancreatic and hepatic glucokinase in a glucose-dependent manner. In September 2022, dorzagliatin (with diet control and exercise) as monotherapy and as an add-on to metformin (when glycaemic control is inadequate with metformin alone) was approved in China for improving glycaemic control in adult patients with T2DM. This article summarizes the milestones in the development of dorzagliatin leading to this first approval.

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Authors and Affiliations

  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Yahiya Y. Syed

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  1. Yahiya Y. Syed
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Correspondence to Yahiya Y. Syed.

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The preparation of this review was not supported by any external funding.

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During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yahiya Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Syed, Y.Y. Dorzagliatin: First Approval. Drugs 82, 1745–1750 (2022). https://doi.org/10.1007/s40265-022-01813-0

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