Zydus eyes Q4 FY27 US launch for liver disease drug after FDA review

The US FDA has granted priority review to Saroglitazar, Zydus Lifesciences' drug for treating Primary Biliary Cholangitis

Zydus Lifesciences on Thursday said it is preparing for a potential US launch of Saroglitazar in the fourth quarter of FY27 after the US Food and Drug Administration (US FDA) granted priority review to the drug’s New Drug Application (NDA).

 

The company said the US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, paving the way for a possible commercial launch in the US market before the end of FY27, subject to regulatory approval.

 

Saroglitazar is being developed by Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, for the treatment of Primary Biliary Cholangitis (PBC), a rare autoimmune liver disease.

 

 

Saroglitazar has previously received orphan drug designation and fast-track designation from the US FDA.

 

PBC is a chronic autoimmune disease that progressively damages bile ducts in the liver and can eventually lead to cirrhosis, liver transplantation or liver failure.

 

Sharvil Patel, managing director of Zydus Lifesciences, said, “The acceptance of our NDA with Priority Review highlights the significant unmet need that exists for patients with PBC and represents an important step in the path to making saroglitazar available in the US.”

 

Patel said the company is building its medical affairs and commercialisation capabilities ahead of the planned US launch in Q4 FY27.

 

The NDA filing is backed by data from the Phase 3 EPICS-III clinical trial, in which Saroglitazar met its primary endpoint by demonstrating statistically significant improvement in biochemical response among PBC patients compared with placebo.

 

According to the company, 56.7 per cent of patients receiving Saroglitazar achieved biochemical response versus 9.8 per cent in the placebo group. The trial also showed significant reductions in alkaline phosphatase (ALP), a key biomarker linked to disease progression in PBC.

 

The Phase 3 results are scheduled to be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona.

 

Priority Review status is granted by the US FDA to applications for drugs that could provide significant improvements in the treatment or diagnosis of serious conditions.