Imeglimin Hydrochloride: First Approval

Drugs. 2021 Sep;81(14):1683-1690. doi: 10.1007/s40265-021-01589-9.

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.

Publication types

  • Review

MeSH terms

  • Clinical Trials, Phase III as Topic
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Drug Approval
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Japan
  • Triazines / therapeutic use*

Substances

  • Hypoglycemic Agents
  • Triazines
  • imeglimin