Ipsen Reports Positive Phase 3/4 Data for IQIRVO in PBC Cholangitis and Fatigue

Ipsen said on May 28, 2026, that new Phase 3 and Phase 4 trial data showed its drug IQIRVO (elafibranor) improved cholangitis symptoms and fatigue in adults with primary biliary cholangitis (PBC). The findings were presented at a medical meeting. The Phase 3 data demonstrated a statistically significant reduction in alkaline phosphatase levels, a key liver disease marker, in patients with PBC-related cholangitis. A separate Phase 4 study found that IQIRVO significantly reduced fatigue severity—a common and debilitating symptom in PBC—compared to placebo. Safety profiles were consistent with earlier trials. IQIRVO, a dual PPARα/δ agonist, is already approved in the U.S. and European Union for PBC. These new results bolster its positioning in the niche liver disease market.