Summary
- Zydus Therapeutics has revealed promising results from the EPICS-III Phase 2(b)/3 trial for saroglitazar, aimed at treating primary biliary cholangitis (PBC).
- Presented at the ACG 2026 Annual Meeting, the trial showed a significant biochemical response, particularly in U.S. patients (60.7% vs. 0% for placebo).
- Despite these findings, saroglitazar is still awaiting FDA approval, although it has received Orphan Drug Designation and Fast Track Designation.
- If approved by March 2027, saroglitazar could significantly advance treatment options for PBC patients with inadequate responses to current therapies.
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