Zydus to go ahead with clinical trial of Saroglitazar

The company will be allowed to evaluate Saroglitazar in strengths of 1mg, 2mg and 4mg versus placebo

Drug firm Zydus Cadila has received approval from the US  health regulator to initiate a phase II clinical trial of Saroglitazar in patients with non-alcoholic steatohepatitis (NASH) of the liver.

The company has received nod from the US Food and Drug Administration (USFDA) to conduct randomised, double-blind phase II trial to evaluate Saroglitazar in strengths of 1mg, 2mg and 4mg versus placebo.

“NASH is an area of unmet healthcare need as there are no drugs approved for the treatment of NASH. Saroglitazar has significant and differentiated effect on hepatic steatosis, while it shows all other beneficial effects on reducing inflammation and fibrosis in the liver in NASH models,” said, Pankaj Patel,  chief managing director, Zydus Cadila.

NASH is a liver disease in which fat accumulates in the liver. The diagnosis of NASH is commonly carried out using liver biopsy. This condition can progress to cirrhosis and liver failure. Liver  transplantation is the only treatment for advanced cirrhosis with liver failure.