Sun Pharma Gets SEC Nod to Conduct Phase III Trial of Resmetirom Tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended allowing Sun Pharma Laboratories Ltd. to conduct a Phase III clinical trial of Resmetirom tablets 60 mg, 80 mg and 100 mg.
According to the minutes, the company presented its proposal seeking permission to manufacture and market Resmetirom tablets in three strengths, along with a bioequivalence (BE) study report and Phase III clinical trial protocol, before the committee.
“After detailed deliberation, the committee considered the BE study results of Resmetirom Tablets 100 mg and recommended for grant of permission to conduct Phase III clinical trial of Resmetirom 60 mg, 80 mg and 100 mg as per protocol presented by the firm (Protocol No- ICR/25/013, Version No-1.0 dated 09.06.2025). Accordingly, the firm should submit Phase III clinical trial report to CDSCO for further review by the committee,” the minutes stated.
Resmetirom is in a class of medications called thyroid hormone receptor (THR)-beta agonists. It works by keeping the liver from forming fat.
Resmetirom's mechanism of action involves activating thyroid hormone receptor beta (THR-β) in the liver, which is primarily responsible for regulating lipid metabolism. This activation leads to reduced fat accumulation (steatosis), enhanced fatty acid oxidation, and decreased lipotoxicity, ultimately slowing the progression of NASH (Non-alcoholic Steatohepatitis).The SEC recommendation clears the way for Sun Pharma to initiate its Phase III study in India. The firm has been directed to submit the clinical trial report to CDSCO upon completion for further regulatory review.
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