Dr Reddy's Laboratories Gets CDSCO Panel Nod To Manufacture, Market Elobixibat Tablet
New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Elobixibat tablets (5 mg).
This came after Dr. Reddy's Laboratories presented the phase III clinical trial report of the new drug Elobixibat Tablets 5mg before the committee.
Elobixibat is an inhibitor of the ileal bile acid transporter (IBAT), undergoing development in clinical trials for the treatment of chronic constipation and irritable bowel syndrome with constipation (IBS-C). Elobixibat reduces active ileal reabsorption of bile acids, increasing the concentration of bile acids entering the colon, which leads to bowel movements via stimulation of colonic secretion and motility.
Elobixibat is an inhibitor of IBAT, which is an alternative name for the apical sodium bile acid transporter (ASBT) encoded by the SLC10A2 gene. ASBT/IBAT is a bile acid:sodium symporter responsible for the reuptake of bile acids in the ileum, the initial step in their enterohepatic circulation. By inhibiting the uptake of bile acids, elobixibat increases the bile acid concentration in the gut, which accelerates intestinal passage and softens the stool.
At the recent SEC meeting for gastroenterology and hepatology held on June 20, 2024, the expert panel reviewed the phase III clinical trial report of the new drug Elobixibat Tablets 5 mg.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market new drug drugs Elobixibat Tablets 5mg.
