Accueil   Diary - News   All news Poxel and Sumitomo Dainippon Pharma Announce Initiation of Phase 3 Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan

Poxel and Sumitomo Dainippon Pharma Announce Initiation of Phase 3 Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan

  • Start of Phase 3 program for Imegliminin Japan on track as plannedté
  • Japanese New Drug Application submission for Imeglimin targeted in 2020
  • Diabetes is a fast-growing market in Asia and Japan is the second largest single market for type 2 diabetes outside of the U.S.

LYON, France & OSAKA, Japan- (BUSINESS WIRE)-- POXEL SA, a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes, and Sumitomo Dainippon Pharma Co., Ltd , announced today the initiation of the Phase 3 program for Imeglimin, an investigational therapeutic agent for type 2 diabetes, in Japan.

 

 

Referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), the Imeglimin Phase 3 program in Japan will include three pivotal trials to evaluate Imeglimin’s efficacy and safety in approximately 1,100 patients. In December 2017, the first patient was included in the TIMES 1 trial, a multicenter, double-blind, placebo-controlled, randomized, monotherapy study in over 200 Japanese patients with type 2 diabetes.

 

 

Read the press release