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Healthcare major Zydus Cadila on Thursday announced having received US drug regulator US Food and Drug Administration (USFDA) approval for the group’s plans to initiate a Phase-2 clinical trial of Saroglitazar Magnesium (Mg) in patients with Primary Biliary Cholangitis of the liver.
In a statement issued here, the company informed that the randomized, double-blind Phase 2 trial will evaluate Saroglitazar Magnesium 2mg and 4 mg Vs. Placebo.
Pankaj Patel, Chairman and Managing Director, Zydus Cadila commented, "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."
Primary Biliary Cholangitis (PBC) 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.
PBC is often discovered incidentally due to abnormal results on routine liver blood tests.
Progression of PBC leads to symptoms of cirrhosis like yellowing of the skin, swelling of legs and feet (edema), ascites, internal bleeding (varices) and thinning of the bones (osteoporosis).
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