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Phase 4 Open-label study of Imeglimin in Japanese Type 2 Diabetic Patients with Renal Impairment

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Trial Profile

Phase 4 Open-label study of Imeglimin in Japanese Type 2 Diabetic Patients with Renal Impairment

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 02 Jun 2025

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At a glance

  • Drugs Imeglimin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions
  • Acronyms TWINKLE
  • Sponsors Poxel; Sumitomo Pharma

Most Recent Events

  • 28 May 2025 According to Poxel media release, data from the study will be presented at the 68th Annual Meeting of the Japan Diabetes Society (JDS 2025), taking place from May 29 to 31, 2025, in Okayama, Japan.
  • 08 Apr 2025 According to a Poxel media release, based on the results company has initiated discussions with the regulatory authorities in Japan for revising TWYMEEG package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m2 and resulting in the approval that will be officially implemented by Sumitomo Pharma as of April 8, 2025.
  • 19 Feb 2025 According to a Poxel media release, based on the results company has initiated discussions with the regulatory authorities in Japan for revising TWYMEEG package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m2 and expects outcome in the first half of 2025.

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