Zydus Arm Reports Positive Results For Liver Disease Drug, Eyes FDA Filing In 2026

(MENAFN- Live Mint) Zydus Therapeutics, a subsidiary of Zydus Lifesciences , said on Friday that its investigational drug Saroglitazar showed positive results in a late-stage trial for patients with primary biliary cholangitis (PBC), a rare chronic liver disease.

The firm plans to file for USFDA regulatory approval in the first quarter of 2026, the company said in a release. Saroglitazar has been approved in India since 2020 for treating non-alcoholic fatty liver disease (NAFLD) and its progressive form, NASH (non-alcoholic steatohepatitis).

The EPICS-III phase 2(b)/3 clinical trial tested how safe and effective Saroglitazar is for adults who couldn't tolerate or didn't benefit from ursodeoxycholic acid (UDCA), the usual treatment.

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The study found that nearly half the patients receiving Saroglitazar achieved significant improvement in key liver functionmarkers compared to those on placebo. The medicine was generally well tolerated, with side effects balanced between those on Saroglitazar and those in the placebo group.

The drug also met a key secondary goal, with more patients reaching full normalization of alkaline phosphatase, a marker linked to disease progression.

The trial enrolled 149 patients across multiple centres and tested a 1mg daily dose of the drug. The company said full results will be presented at an upcoming scientific congress.

Saroglitazar is the first drug of its kind to show strong Phase 3 results in PBC patients, and it could offer a valuable new option for those who need alternatives, Zydus chairman Pankaj Patel said.

The drug has received fast-track designation and orphan drug designation from the US FDA for PBC treatment.

PBC is a rare, progressive autoimmune disease which gradually destroys the bile ducts, resulting in an accumulation of bile in the liver. This can lead to fibrosis, cirrhosis and the need for liver transplantation or death. Clinical symptoms include itching and fatigue, both of which can be severe.

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The USFDA has designated it a rare orphan disease, which affects fewer than 200,000 people. The company currently estimates that a quarter of a million adult patients in the US have PBC.

Zydus Therapeutics is a US-based clinical-stage, speciality-focused biopharmaceutical company that develops treatments for rare and serious liver diseases. According to its website, the firm is also developing Saroglitazar as an investigational treatment for non-alcoholic steatohepatitis globally.

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Saroglitazar was India's first completely indigenous new chemical entity to be approved domestically in 2013. It was initially approved and launched for the treatment of diabetes with an excess of lipids, and later approved for liver disease treatments in 2020.

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