Drug firm Gujarat based Zydus Cadila today said it 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, Zydus Cadila said in a statement.
"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," Zydus Cadila CMD Pankaj Patel said.
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, Zydus Cadila said in a statement.
"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," Zydus Cadila CMD Pankaj Patel said.
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