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Drugs. 2021 Sep;81(14):1683-1690. doi: 10.1007/s40265-021-01589-9.
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.
盐酸伊美格鲁肽（TWYMEEG；以下简称伊美格鲁肽）是一种口服的、首创的葡萄糖激酶激活剂类药物，由 Poxel 公司研发，在亚洲的多个国家，由住友制药（Sumitomo Dainippon Pharma）进行推广，用于治疗 2 型糖尿病（T2D）。葡萄糖激酶激活剂类药物是一类新型的降糖药物，针对糖尿病相关病理的多个环节。2021 年 6 月，伊美格鲁肽在日本获得了用于治疗 T2D 的首个批准。日本的批准是基于广泛的临床前和临床数据，包括关键性 III 期 TIMES 研究的积极结果。本文总结了伊美格鲁肽开发过程中的重要里程碑，这些里程碑促成了该药在 T2D 方面的首次批准。
