Zydus: Saroglitazar Shows Greater Response in PBC Trial

Zydus Lifesciences' subsidiary, Zydus Therapeutics, presented new post hoc analysis from its Phase 3 EPICS-III trial of saroglitazar for primary biliary cholangitis (PBC) at the ACG 2026 Annual Meeting. The analysis indicated a numerically higher biochemical response treatment difference with saroglitazar compared to placebo, particularly in U.S. subgroups. Specifically, U.S. patients showed a 60.7% response difference versus 41.6% in non-U.S. subgroups. These findings build on saroglitazar's clinical profile in PBC patients with inadequate response or intolerance to UDCA. Saroglitazar is currently under review by the FDA, with a planned U.S. launch by March 2027 if approved. The drug was generally well-tolerated in the trial.