CDSCO panel grants clearance to Morepen Labs to conduct BE studies for fatty liver disease drug Resmetirom

Gurugram: Morepen Laboratories Ltd. has received clearance from the 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.

“This is a critical step forward in our journey to bring a much-needed innovation to the hepatology market,” said Sanjay Suri, Executive Director, Morepen Laboratories.

“We are proud to be one of the first few Indian companies gearing up to launch the finished formulation of Resmetirom. Our endto-end integration – from APIs to finished dosage – gives us a unique edge in speed, quality, and scalability.”

"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," the Company said.

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 USD 2.5 billion in 2024 to over USD 16 billion by 2032, driven by increasing prevalence, clinical awareness, and regulatory approvals.