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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: 19 Sep 2026

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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

  • 28 May 2026 According to a media release from Zydus Lifesciences, the EPICS-III trial Phase 3 results will be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress in Barcelona, Spain on Saturday, May 30, 2026.
  • 28 May 2026 According to a media release from Zydus Lifesciences, the company announced that the U.S. FDA has accepted the New Drug Application (NDA) for saroglitazar and granted it Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. If approved, Zydus Therapeutics plans to launch saroglitazar in the United States by March 2027. The NDA is supported by the Phase 3 EPICS-III trial results.
  • 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.

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