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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Oct 2025

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At a glance

  • Drugs Saroglitazar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Registrational; Therapeutic Use
  • Acronyms EPICS-III
  • Sponsors Zydus Pharmaceuticals (USA)

Most Recent Events

  • 29 Aug 2025 According to a Zydus Cadila media release, company intend to discuss these results with regulatory agencies and plan to move forward with a regulatory submission to the U.S. Food and Drug Administration in the first quarter of 2026.
  • 29 Aug 2025 According to a Zydus Cadila media release, Raj Vuppalanchi, MD, Professor of Medicine at Indiana University School of Medicine and Global Principal Investigator for the EPICS-III study.
  • 29 Aug 2025 According to a Zydus Cadila media release, the full data from the EPICS-III trial will be presented at a future scientific congress.

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