Zydus update on clinical trial of Saroglitazar Mg in treatment of PCB (severe liver disease)

Zydus today announced that it has received permission from the USFDA to initiate the Phase 2(b)/3 Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled adaptive clinical trial to evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (PBC).

Speaking on the new development, Chairman of Cadila Healthcare, Pankaj R. Patel said, Primary Biliary Cholangitis (PBC) is a severe liver disease leading to cirrhosis of the liver, liver failure, and possibly death. PBC patients have limited treatment options and approximately 50% of the PBC patients are not able to benefit from the existing therapy due to lack of response or intolerable side effects. Based on the positive results from our earlier Phase 2 study, we have now initiated the pivotal EPICS III trial in both cirrhotic and non-cirrhotic PBC patients.

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