1 day ago
Morepen Laboratories Ltd on Tuesday, April 29, secured approval from the Central Drugs Standard Control Organisation (CDSCO) to conduct studies for Resmetirom, a new drug that treats fatty liver.
The pharmaceutical company received clearance from the Subject Expert Committee (SEC) of CDSCO to conduct bioequivalence (‘BE’) studies for ‘resmetirom’ tablets in the dosages of 60 mg, 80 mg and 100 mg, Morepen Labs said in an exchange filing.
The company will start clinical trials as per approved protocols following the approval from the CDSCO.
Resmetirom is known to be a therapy under development for non-alcoholic steatohepatitis or NASH, which is a serious form of non-alcoholic fatty liver disease that could lead to multiple problems such as scarring or fibrosis, cirrhosis, and even liver cancer.
The disease is usually associated with obesity, metabolic syndrome, and type 2 diabetes. Even though it is a silent disease in the early stages, it can progress to severe liver damage if left untreated.
The said progressive liver disease has affected more than 115 million people worldwide, and as per industry estimates, the market for global NASH treatment is likely to grow from $2.5 billion in 2024 to more than $16 billion by 2032, led by increasing prevalence, clinical awareness, and regulatory approvals.
The company said that it is strategically positioned to serve both domestic as well as international markets, as it is among the first Indian companies to charge into the said domain through Resmetirom. The pharma company is also considering out-licensing opportunities with potential marketing partners.
“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,” said the Executive Director of Morepen Laboratories, Sanjay Suri in a press release on April 29, 2025.
Shares of the pharmaceutical company gained nearly 2% on Tuesday, April 29, to hit an intraday high of ₹63.2 apiece on the BSE. However, the stock pared some of its early gains to trade 0.69% lower at ₹61.55 apiece on the BSE at around 10:30 am.
Also Read: NBCC bags order worth ₹130 crore to develop a township project in Shillong, Meghalaya
