elafibranor + ursodeoxycholic acid

Elafibranor + ursodeoxycholic acid (UDCA) is an oral combination therapy used for the treatment of primary biliary cholangitis (PBC) in adults who have had an inadequate response to UDCA alone. Elafibranor is a small-molecule dual peroxisome proliferator-activated receptor (PPAR) α/δ agonist that reduces bile acid synthesis (via CYP7A1 downregulation) and increases bile acid export. Ursodeoxycholic acid is a naturally occurring, hydrophilic bile acid that serves as the standard first-line therapy for PBC, exerting anti-apoptotic, anti-inflammatory, and cholestasis-reducing effects. The combination was approved by the FDA in June 2024 (with elafibranor marketed under the brand name Iqirvo) based on the Phase 3 ELATIVE trial, which demonstrated a significant biochemical response compared to UDCA alone.

Other names

elafibranor + UDCAelafibranor + ursodiol