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
Price :
$35
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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
- 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.