drugset / Trial / NCT07216235

Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

NCT07216235

Phase 3 Not yet recruiting 386 enrolled Zydus Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)

Timeline

Start
2026-02
Primary completion
2032-11
Completion
2032-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Saroglitazar Small molecule 1 mg Oral