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NOV 28 2026
UPCOMING · 60 DAYS TO PDUFA

Zydus Therapeutics — saroglitazar

for primary biliary cholangitis

NDA · Priority Review

About

Primary biliary cholangitis is an autoimmune liver disease where the immune system slowly destroys the organ's small bile ducts, leading to a toxic buildup of bile. Saroglitazar is an oral drug that activates two key receptors (PPAR α/γ) to regulate how the liver handles fats and inflammation. This dual action may help reduce the bile buildup and liver damage that drives the disease's progression.

Pivotal trial

EPICS-III Phase 2/Phase 3 completed NCT05133336

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

Source: ClinicalTrials.gov

Also in development