Dr. Reddy's Gets CDSCO Panel Nod To Study Tegoprazan for gastrointestinal diseases
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 Organization (CDSCO) to study Tegoprazan used to treat acid-related gastrointestinal diseases.
This came after Dr. Reddy's Laboratories presented revised protocol amendment version 3.0 dated 20-04-2023 before the committee.
Tegoprazan is a potassium-competitive acid blocker (P-CAB) and is a novel potent, and highly selective inhibitor of gastric H+/K+-ATPase.This drug is a potent and high-selective potassium-competitive acid blocker (P-CAB) with a fast onset of action and the ability to control gastric pH for a prolonged period of time.
Tegoprazan works as a potassium-competitive acid blocker that is potent and highly selective. Its mechanism of action is different from that of the proton-pump inhibitors as this drug does not require conversion into an active form and can directly inhibit H+/K+‐ATPase in a reversible and K+‐competitive way. This is because it is an acid-resistant weak base with the ability to remain in the highly acidic canaliculi of gastric parietal cells.
At the recent SEC meeting for Gastroenterology and Hepatology held on 14th June 2023, the expert panel reviewed the revised protocol amendment version 3.0 dated 20-04-2023 for Tegoprazan 50mg tablets.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as per the revised protocol amendment version 3.0 dated 20-04-2023.
Also Read:MSN Lab Gets CDSCO Panel Nod To Manufacture, Market Vigabatrin Powder for Oral Solution
