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NOV 28 2026
UPCOMING · 120 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 liver's small bile ducts, leading to a toxic buildup of bile that can cause scarring and cirrhosis. Saroglitazar is an oral drug that works by activating two key receptors (PPAR α/γ) in liver cells, which helps regulate how the body processes fats and sugars. By improving metabolic function in the liver, this drug may help reduce the cholestasis and inflammation that drive 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

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