Morepen Laboratories Ltd announced on Tuesday, 29 April, that it had received approval from the Central Drugs Standard Control Organisation (CDSCO) to conduct studies on Resmetirom, a novel drug aimed at treating fatty liver disease.

The company stated in a stock exchange filing that the Subject Expert Committee (SEC) of CDSCO has granted permission to initiate bioequivalence (BE) studies for Resmetirom tablets in 60 mg, 80 mg, and 100 mg dosages. Following this clearance, Morepen will commence clinical trials in accordance with approved protocols.

Resmetirom is being developed as a treatment for non-alcoholic steatohepatitis (NASH), a severe form of non-alcoholic fatty liver disease that can lead to liver fibrosis, cirrhosis, and potentially liver cancer. NASH is often linked to obesity, metabolic syndrome, and type 2 diabetes. Though it may remain asymptomatic in its early stages, the condition can escalate into serious liver complications if not managed.

The progressive liver condition affects over 115 million individuals globally, and the NASH treatment market is projected to grow significantly from $2.5 billion in 2024 to over $16 billion by 2032, which is driven by rising prevalence, better diagnosis, and regulatory support.

Morepen Labs highlighted its strategic positioning to cater to both Indian and global markets, being among the first Indian pharmaceutical firms to enter this space with Resmetirom. The company is also exploring potential out-licensing deals with marketing partners.

Sanjay Suri, the Executive Director of Morepen Laboratories, said, “This is a critical step forward in our journey to bring a much-needed innovation to the hepatology market. We are proud to be one of the first few Indian companies gearing up to launch the finished formulation of Resmetirom. Our end-to-end integration — from APIs to finished dosage — gives us a unique edge in speed, quality, and scalability.”

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