Zydus gets USFDA nod for phase II trials of liver drug

New Delhi : Drug firm Zydus Cadila said the US health regulator has approved the group's plans to initiate phase II clinical trials of Saroglitazar Magnesium in patients suffering from a certain liver disease.

"The United States Food and Drug Administration (USFDA) has approved the group's plans to initiate a phase II clinical trial of Saroglitazar Magnesium (Mg) in patients with primary biliary cholangitis (PBC) of the liver," Zydus Cadila said in a statement.

This trial will evaluate Saroglitazar Magnesium 2mg and 4mg vs Placebo, it added.

Commenting on the development, Zydus Cadila Chairman and MD Pankaj R Patel said: "We are very thankful to the USFDA for their timely and useful feedback on the clinical trial designs of Saroglitazar Mg in patients with PBC."

This development underlines the group's commitment to bridging unmet healthcare needs with innovative therapies, he added.

Primary Biliary Cholangitis is a liver disease, caused due to progressive destruction of the bile ducts in the liver which leads to reduction of bile flow a condition referred to as cholestasis, Zydus Cadila said.

Progression of PBC leads to symptoms of cirrhosis like yellowing of the skin, swelling of legs and feet, ascites, internal bleeding and thinning of the bones, it added.

Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 430.50 per scrip on BSE, down 0.93 per cent from its previous close.