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Phase 3 trial of Imeglimin patients with chronic kidney disease (CKD) stages 3b/4, an underserved patient population

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Trial Profile

Phase 3 trial of Imeglimin patients with chronic kidney disease (CKD) stages 3b/4, an underserved patient population

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2020

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At a glance

  • Drugs Imeglimin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Most Recent Events

    • 15 Sep 2020 According to a Poxel media release, further FDA interactions are expected during the second half of 2020.
    • 20 Apr 2020 According to a Poxel media release, the company is working with Metavant who is in discussions with the U.S. Food and Drug Administration for the Imeglimin Phase 3 program in type 2 diabetes patients with chronic kidney disease (CKD) stages 3b/4, an underserved patient population.
    • 26 Mar 2020 According to a Poxel media release, the ongoing discussions with the FDA continue on the development plan for the Imeglimin Phase 3 program in the US.

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