Hetero Labs Gets CDSCO Panel Nod to Study Vonoprazan Tablet
New Delhi: Hetero Labs has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of Vonoprazan, a potassium-competitive acid blocker used in the treatment of acid-related disorders and as an adjunct to Helicobacter pylori eradication.
This came after the firm presented the proposal for a grant of permission to conduct a phase IV clinical trial with the new drug Vonoprazan 20 mg tablets before the committee.
Vonoprazan is a potassium-competitive acid blocker (PCAB) that inhibits H+, K+-ATPase-mediated gastric acid secretion. PCABs represent an alternative to proton-pump inhibitors for the treatment of acid-related disorders.
Vonoprazan is used to heal and maintain healing of erosive esophagitis (inflammation that causes damage to the tube that runs from the throat to the stomach) and helps lessen symptoms of heartburn associated with erosive esophagitis in adults.
At the recent SEC meeting for gastroenterology and hematology held on October 16, 2024, the expert panel reviewed the proposal for the grant of permission to conduct a phase IV clinical trial with the new drug Vonoprazan 20 mg tablets.
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase IV clinical trial as per the presented protocol.
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