Abbott India Gets CDSCO Panel Nod To Conduct Phase III CT of Ursodeoxycholic Acid tablet
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Abbott India to conduct a phase-III clinical trial of Ursodeoxycholic Acid (UDCA) tablets 150 mg/300 mg/450 mg/600 mg.
This came after Abbott India presented the revised Phase-III clinical trial protocol along with a summary of changes before the committee.
Ursodeoxycholic acid is a bile acid used for the treatment of primary biliary cirrhosis (PBC). Ursodeoxycholic acid is a hydrophilic bile acid that mediates its biological effects via several mechanisms. Ursodeoxycholic acid (UDCA) protects hepatocytes and cholangiocytes from bile acid-induced damage, such as reactive oxygen species (ROS)-induced inflammation and mitochondrial dysfunction. UDCA was shown to reserve hepatocyte cell structures and stimulate anti-apoptotic pathways.It was also shown to prevent the production of ROS by Kupffer cells and resident macrophages in the liver, thus attenuating oxidative stress in the liver.
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