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A phase III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study to evaluate safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients with Non-alcoholic Fatty Liver Disease

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Trial Profile

A phase III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study to evaluate safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients with Non-alcoholic Fatty Liver Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Norursodeoxycholic acid (Primary)
  • Indications Non-alcoholic fatty liver disease
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 09 Apr 2025 New trial record
    • 12 Mar 2025 According to a Shilpa Medicare media release, Company is looking forward to marketing approval soon, and plans to launching it in India in the coming financial year. Based on the approval in India, company plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally.
    • 12 Mar 2025 Results published in the Media Release

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