Mankind Pharma Gets CDSCO Panel Nod to Conduct Phase III Trial of Resmetirom Tablets
New Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Mankind Pharma Ltd to conduct a Phase III clinical trial for Resmetirom Tablets in three strengths, 60 mg, 80 mg, and 100 mg.
The proposal was discussed during the 07th SEC meeting held on 12th June 2025 at CDSCO headquarters in New Delhi. The company submitted the bioequivalence (BE) study results along with the Phase III clinical trial protocol, in continuation of an earlier SEC recommendation dated 27th February 2025.
After detailed deliberation, the committee found the BE results to be satisfactory and recommended the grant of permission to conduct the Phase III trial. However, it added a site selection condition. According to the minutes:
“The firm should include sites preferably having liver disease management facility.”
Resmetirom is a selective thyroid hormone receptor-β agonist under development for the treatment of nonalcoholic steatohepatitis (NASH) and other liver-related metabolic disorders. The drug aims to improve liver histology while avoiding systemic thyromimetic effects — a key differentiator in this emerging therapeutic area.
