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A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)

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Trial Profile

A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)

Status: Not yet recruiting
Phase of Trial: Phase 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-V
  • Sponsors Zydus Pharmaceuticals (USA)

Most Recent Events

  • 21 Oct 2025 New trial record

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