Morepen Labs Ignites Hope: Pioneering Resmetirom Set to Transform Fatty Liver Care in India

Unknown Apr 02, 2026 1,150 Views

Morepen Laboratories Ltd will make a major entry into liver disease treatment following clearance by the Central Drugs Standard Control Organization (CDSCO) to carry out bioequivalence (BE) studies for Resmetirom, a novel drug for non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). The development places Morepen among the earliest Indian firms to bring this novel therapy, recently cleared in the US, into the local market.

Key Highlights:

CDSCO Approval: Official sanction has been obtained by Morepen Laboratories from CDSCO to undertake BE studies of Resmetirom tablets (60 mg, 80 mg, and 100 mg), a key milestone towards local manufacturing and marketing of this new medicine for fatty liver disease.
About Resmetirom: Resmetirom is a selective thyroid hormone receptor-β (THR-β) agonist, recently granted accelerated approval by the US FDA for the treatment of adults with noncirrhotic NASH with moderate to advanced fibrosis of the liver. It acts on liver fat metabolism, decreasing hepatic fat, and enhancing liver health.
Clinical Evidence: International research demonstrates Resmetirom highly decreases liver fat, enhances liver enzymes, and is able to reverse NASH or improve fibrosis following treatment for 52 weeks. Its safety and effectiveness profile is watched closely in currently ongoing global studies.
Future Steps in India: The CDSCO requested Morepen to go ahead with BE studies according to the protocol submitted and provide additional clinical data, particularly from Indian and Southeast Asian populations, for additional regulatory consideration. Waiver for a local Phase III trial was not given at this point, allowing for strict testing before broader implementation.
Market Impact: With fatty liver disease increasing in India, Morepen's decision to launch Resmetirom could provide a long-awaited, evidence-based therapeutic solution for millions of patients.