Hetero Labs gets CDSCO Panel nod to study Tegoprazan tablet 50 mg
New Delhi: Responding to the proposal presented by Hetero Labs, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm conduct a bioequivalence study and phase III clinical trial of Tegoprazan tablet 50 mg.
This came after Hetero Labs presented a proposal for a grant for a Phase III clinical trial of Tegoprazan tablets 50 mg along with a bioequivalence study protocol and a Phase III clinical trial protocol before the committee.
Tegoprazan is a novel therapeutic for treating acid-related gastrointestinal diseases.
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
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