Zydus Therapeutics Inc., a subsidiary of Zydus Lifesciences Limited, has unveiled new findings from the EPICS-III Phase 2(b)/3 clinical trial, showcasing the investigational drug saroglitazar’s potential in treating primary biliary cholangitis (PBC). The results were presented at the American College of Gastroenterology (ACG) 2026 Annual Meeting.
The trial explored the efficacy of saroglitazar, a novel Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist, in adult patients with PBC who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA). The post hoc analysis focused on geographic subgroups, comparing the drug’s effects in U.S. patients against those from other regions, including Argentina, Iceland, and Turkey. The results indicated a significant biochemical response in both subgroups, with a more pronounced effect observed in the U.S. cohort (60.7% vs. 0% for placebo) compared to the non-U.S. group (55.1% vs. 13.5% for placebo).
The study, led by Dr. Raj Vuppalanchi from Indiana University School of Medicine, highlighted that the treatment difference between saroglitazar and placebo was notably larger in the U.S. subgroup. Despite these promising results, saroglitazar has not yet received approval from the U.S. Food and Drug Administration (FDA), and its safety and efficacy remain under review. The drug has, however, been granted Orphan Drug Designation, Fast Track Designation, and Priority Review by the FDA for PBC treatment.
Zydus Therapeutics aims to launch saroglitazar in the U.S. by March 2027, contingent upon FDA approval. The company is committed to further analysing the EPICS-III data to enhance understanding of the drug’s impact across different populations. Analysts suggest that if approved, saroglitazar could offer a significant advancement in PBC treatment, addressing unmet needs for patients who do not respond adequately to existing therapies.
