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

At the recent SEC meeting for gastroenterology and hepatology held on 17th March 2025, the expert panel reviewed the Phase III clinical trial of Tegoprazan tablets 50 mg along with the bioequivalence study protocol and Phase III clinical trial protocol before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct a bioequivalence study and a Phase III clinical trial, as per the protocol presented.

Further, the committee opined that the firm should submit a bioequivalence study report to CDSCO for review by the committee before initiating the Phase III clinical trial.

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