Trial Profile

A phase III, double-blind, placebo-controlled, monotherapy study of imeglimin (TIMES 1)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

Drugs Imeglimin (Primary)
Indications Type 2 diabetes mellitus
Focus Registrational; Therapeutic Use
Acronyms TIMES 1
Sponsors Cmic; Poxel; Sumitomo Dainippon Pharma

Most Recent Events

23 Jun 2021 According to Poxel media release, a new drug application for TWYMEEG Tablets 500mg3 for the treatment of type 2 diabetes, was approved in Japan supported by positive results from the Phase 3 TIMES program
20 May 2021 Results published in the Poxel Media Release.
20 May 2021 According to a Poxel media release, New Drug Application (J-NDA) approval is expected in mid-2021.

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