In a key development reinforcing its leadership in the Indian pharmaceutical landscape, 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) characterised 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.
NASH, a progressive liver disease that affects over 115 million people worldwide. According to industry estimates, the global NASH treatment market is projected to grow from $2.5 billion in 2024 to over $16 billion by 2032, driven by increasing prevalence, clinical awareness, and regulatory approvals.
Morepen’s early-mover advantage in Resmetirom, combined with its scale, integration, and regulatory strength, make it a compelling investment opportunity in the fast-evolving specialty and chronic care segments.
