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Imeglimin Hydrochloride: First Approval

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Abstract

Imeglimin hydrochloride (TWYMEEG®; hereafter referred to as imeglimin) is an orally administered, first-in-class glimin being developed by Poxel and, in several Asian countries, Sumitomo Dainippon Pharma for the treatment of type 2 diabetes (T2D). The glimins are a novel class of glucose-lowering agents that target multiple components of diabetes-associated pathology. In June 2021, imeglimin received its first approval for use in T2D in Japan. The Japanese approval was based on extensive preclinical and clinical data, including positive results from the pivotal phase III TIMES programme. This article summarizes the milestones in the development of imeglimin leading to this first approval for T2D.

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

    Yvette N. Lamb

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  1. Yvette N. Lamb
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Correspondence to Yvette N. Lamb.

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

Conflict of interest

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. Yvette Lamb 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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Lamb, Y.N. Imeglimin Hydrochloride: First Approval. Drugs 81, 1683–1690 (2021). https://doi.org/10.1007/s40265-021-01589-9

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