Non-Drinker with Fatty Liver... World's First Treatment for 'Metabolic Dysfunction-Associated Steatohepatitis' Released

US Madrigal's 'Lezdepride' FDA Approval
Domestic Pharmaceutical Companies Hanmi, Yuhan, and Dong-A Also Challenge Development

The first treatment for metabolic dysfunction-associated steatohepatitis (MASH), a type of hepatitis caused by metabolic dysfunctions such as obesity and diabetes, has been developed.

On the 14th (local time), Madrigal Pharmaceuticals in the United States announced that Rezpegaldesleukin, developed as a treatment for metabolic dysfunction-associated steatohepatitis, received approval from the U.S. Food and Drug Administration (FDA). Rezpegaldesleukin demonstrated effectiveness in improving liver fibrosis and fatty liver, the main symptoms of this disease, in clinical trials.

Metabolic dysfunction-associated steatohepatitis was previously called non-alcoholic steatohepatitis, but the name was changed due to misunderstandings related to alcohol consumption, which is not directly related to the actual cause of the disease. The number of patients with metabolic dysfunction-associated steatohepatitis has been rapidly increasing recently. Patients in major countries worldwide, including the U.S., China, five European countries, and Japan, are increasing at an average annual rate of 47%, and it is expected to reach 100 million by 2030. The treatment market is also expected to grow rapidly. Currently, existing hepatitis treatments are prescribed, but GlobalData, a data analysis and consulting firm, predicts that if new drug development progresses, the market size could grow to $27.2 billion (approximately 36 trillion KRW) by 2029.

However, despite massive development costs invested by global pharmaceutical companies, many have failed consecutively in developing treatments, earning the disease the nickname "the graveyard of global big pharma," as no suitable treatment has emerged. Gilead Sciences’ Seronsertib failed several years ago, and Novo Nordisk’s Ozempic, a top hit for diabetes and obesity treatment, also faced setbacks in attempting to gain approval for metabolic dysfunction-associated steatohepatitis and is currently preparing for a retry.

Domestic pharmaceutical companies have also entered the competition. Candidate substances utilizing the recently spotlighted ingredient ‘GLP-1’ dominate the field. Hanmi Pharmaceutical, Yuhan Corporation, and Dong-A ST are competing in development.

Hanmi Pharmaceutical is conducting clinical trials for a metabolic dysfunction-associated steatohepatitis treatment with a triple mechanism of action involving GLP-1, glucagon, and glucose-dependent insulinotropic polypeptide (GIP), which have similar effects. Separately, Hanmi has licensed the GLP-1/glucagon dual agonist epinofegdutide to the U.S. pharmaceutical company MSD, which is currently in clinical trials. Yuhan Corporation is collaborating with Boehringer Ingelheim. They have licensed the new drug candidate YH25724 and started clinical trials. Dong-A ST, after acquiring U.S.-based NeuroBo Pharmaceuticals, is conducting clinical trials for two new drug candidates, one for metabolic dysfunction-associated steatohepatitis and the other for type 2 diabetes treatment, which were exported together.