Morepen Laboratories Ltd. has received clearance from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct bioequivalence (BE) studies for Resmetirom tablets in 60 mg, 80 mg, and 100 mg doses. The approval is based on the protocols submitted by the company. Following the successful completion of BE studies, Morepen will proceed with clinical trials as per approved protocols.
Resmetirom is a therapy currently under development for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a progressive and serious form of non-alcoholic fatty liver disease (NAFLD), characterized by liver inflammation, fat accumulation, and potential progression to fibrosis, cirrhosis, or liver cancer. It is commonly associated with conditions like obesity, metabolic syndrome, and type 2 diabetes. In many cases, NASH remains asymptomatic until it advances to more severe stages of liver damage.
By initiating work in this therapeutic area, Morepen becomes one of the early Indian companies developing treatments for NASH. The company is also exploring out-licensing opportunities with potential marketing partners to expand the reach of Resmetirom.
According to industry estimates, the global NASH treatment market is projected to grow from approximately USD 2.5 billion in 2024 to over USD 16 billion by 2032. This growth is driven by rising disease prevalence, increased clinical awareness, and regulatory advancements worldwide.
Morepen Laboratories has an established global presence, exporting active pharmaceutical ingredients (APIs) and finished formulations to over 80 countries, including regulated markets such as the United States, Europe, and Japan. Its manufacturing facilities comply with major international standards, including USFDA, EU-GMP, and WHO-GMP certifications.
