Dr. Reddy's Gets CDSCO Panel Nod to study gastric acid blocker Vonoprazan fumarate
New Delhi: In line with the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Dr. Reddy's Laboratories to conduct the Phase III clinical trial on the Vonoprazan fumarate, a novel class of potassium-competitive gastric acid blockers.
This came after the firm presented the proposal for grant of permission for manufacturing and marketing the drug Vonoprazan fumarate tablets 10 mg and 20 mg along with Phase III clinical trial protocol and BE study report before the committee.
Vonoprazan fumarate is used as an oral medication prescribed once daily for both treatments of gastric ulcers and the secondary prevention of gastric acid reflux.
The mechanism of action of vonoprazan is that it competes with potassium ions for the reversible inhibition of Hþ-Kþ-ATPase, whereas Proton pump inhibitors (PPIs) act by binding covalently to the gastric Hþ, Kþ-ATPase via disulfide bonds.
At the recent SEC meeting for Gastroenterology and Hepatology held on 23rd May 2023, the expert panel reviewed the proposal for grant of permission for manufacturing and marketing of the drug Vonoprazan fumarate tablets 10 mg and 20 mg along with Phase III clinical trial protocol and BE study report.
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