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.”
However, the approval comes with a critical caveat regarding BE data submission, “Further, the committee opined that the firm should submit Bioequivalence study report to CDSCO for review by the committee before initiating the Phase III clinical trial.”
The recommendation pertains to file number ND/MA/24/000173, submitted by Ravenbhel Biotech, a pharmaceutical firm engaged in the development of generic and specialty formulations in areas such as gastroenterology, hepatology, and metabolic disorders.
Resmetirom (MGL-3196) is an investigational thyroid hormone receptor-beta (THR-β) selective agonist under development for the treatment of non-alcoholic steatohepatitis (NASH) and metabolic dysfunction-associated steatotic liver disease (MASLD). The compound aims to reduce liver fat and improve metabolic outcomes without inducing systemic thyroid effects.
