Indian-based healthcare company Zydus Cadila has obtained the US Food and Drug Administration (FDA) approval to begin a Phase II trial of saroglitazar magnesium (Mg) for the treatment of patients with primary biliary cholangitis (PBC) of the liver.
Saroglitazar Mg is an investigational new drug being developed to treat PBC, non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (TG more than 500) in the US.
It is designed to decrease the levels of TG, LDL-c, FPG, PPG, HbA1c, ApoB and ALT.
The randomised, double-blind Phase II trial will assess the drug in 2mg and 4mg doses, which will be compared to the placebo.
Zydus Cadila chairman and managing director Pankaj 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 Primary Biliary Cholangitis (PBC).
"This development underlines our commitment to bridging unmet healthcare needs with innovative therapies.”
PBC is a liver disease caused due to the progressive destruction of the bile ducts in the liver, resulting in cholestasis characterised by the reduction of bile flow, which can lead to build-up of toxic bile in the liver and end in liver inflammation and fibrosis.
Launched in September 2013, Lipaglyn is a prescription drug of saroglitazar Mg only authorised in India for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with Type 2 diabetes not controlled by statins.
Zydus discovers, develops, manufactures and markets a wide range of small-molecule drugs, biologic therapeutics and vaccines.