Morepen receives CDSCO nod to conduct BE studies for Resmetirom

For treatment of liver disease

Morepen Laboratories has got clearance from Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to conduct Bioequivalence (BE) studies for Resmetirom 60 mg, 80 mg and 100 mg tablets as per the protocol submitted. This will be followed by clinical trials as per approved protocols.

Resmetirom is a highly promising therapy under development for non-alcoholic steatohepatitis ('NASH'), a serious form of non-alcoholic fatty liver disease (NAFLD) characterized by inflammation, liver damage, and fat accumulation in the liver, potentially leading to scarring (fibrosis), cirrhosis, and even liver cancer. It is often associated with obesity, metabolic syndrome, and type 2 diabetes, and while it can be a silent disease in the early stages, it can progress to severe liver damage if left untreated.

 

As one of the first Indian companies to foray into this therapeutic area, Morepen is strategically positioned to serve both domestic and international markets and is also evaluating out-licencing opportunities with potential marketing partners.

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