saroglitazar + ursodeoxycholic acid

Saroglitazar plus ursodeoxycholic acid (UDCA) is a combination regimen under development for the treatment of primary biliary cholangitis (PBC). Saroglitazar is a small-molecule dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist developed by Zydus Lifesciences. By activating PPARα, saroglitazar reduces hepatic bile acid synthesis and enhances bile acid detoxification, while PPARγ activation provides immunomodulatory and anti-inflammatory effects. Ursodeoxycholic acid is an established hydrophilic bile acid that acts as a first-line therapy for PBC, protecting hepatocytes and cholangiocytes from bile acid-induced damage and reducing bile acid toxicity. The combination is intended for adult patients with PBC who have had an inadequate response to UDCA. A New Drug Application (NDA) for saroglitazar in combination with UDCA (or as monotherapy for patients intolerant to UDCA) is under FDA review with a PDUFA target action date of November 27, 2026, supported by the Phase 3 EPICS-III trial.

Other names

saroglitazar + UDCAsaroglitazar magnesium + UDCAsaroglitazar magnesium + ursodeoxycholic acid