Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First
New Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation (CDSCO) has permitted Ravenbhel Biotech to proceed with a Phase III clinical trial of its Resmetirom Tablets 60 mg, 80 mg, and 100 mg, contingent upon submission of a Bioequivalence (BE) study report.
The firm presented a revised Phase III clinical trial protocol before the committee during the SEC meeting held on 25th June 2025, in continuation of an earlier SEC recommendation dated 17th March 2025.
Quoting the official meeting minutes, the committee noted, “In light of the earlier SEC recommendation dated 17.03.2025, the firm presented revised Phase-III CT protocol of Resmetirom Tablet 60/80/100 mg, before the committee.”
After evaluating the updated protocol, the SEC gave conditional approval, “After detailed deliberation, the committee recommended for grant of permission to conduct Phase III clinical trial with Resmetirom Tablet 60/80/100 mg as per the revised protocol presented.”
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