CDSCO Panel Rejects Morepen Laboratories' Proposal To Waive local Phase III clinical trial of Resmetirom Tablet

New Delhi: Rejecting the proposal for the local Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended Morepen Laboratories to submit Phase III clinical trial protocol of Resmetirom Tablet (60 mg, 80 mg & 100 mg).

In addition, the committee the committee recommended grant of permission to conduct Bioequivalence study as per the protocol presented.

This came after the firm presented proposal for grant of permission to manufacture and market of new drug Resmetirom Tablet along with Bioequivalence study protocol and justification for local Phase III clinical trial waiver before the committee.

Resmetirom is in a class of medications called thyroid hormone receptor (THR)-beta agonists. It works by keeping the liver from forming fat.

Resmetirom is used for treatment of adult patients with nonalcoholic steatohepatitis (NASH; liver inflammation and damage caused by build up of fat in the liver) with moderate to advanced liver fibrosis (changes in liver tissue seen with early liver damage) but not cirrhotic (scarring of the liver that keeps the liver from functioning properly).

Resmetirom is a medication approved for treating noncirrhotic nonalcoholic steatohepatitis (NASH) in adults. It's a thyroid hormone receptor beta (THR-β) agonist, meaning it helps regulate lipid metabolism and reduce liver fat in the liver. Resmetirom is taken in conjunction with dietary and exercise changes.

At the recent SEC meeting for Gastroenterology and Hepatology held on 17th March 2025, the expert panel reviewed proposal for grant of permission to manufacture and market of new drug Resmetirom Tablet along with Bioequivalence study protocol and justification for local Phase III clinical trial waiver.

After detailed deliberation, the committee recommended grant of permission to conduct Bioequivalence study as per the protocol presented.

However, the committee did not recommend for the local Phase III clinical trial waiver and recommended to submit Phase III clinical trial protocol for further consideration by the committee.

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