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DongaST and its U.S. affiliate Metavigil are working on DA-1241, a therapy for metabolic dysfunction-associated steatohepatitis (MASH).

Often called “fatty liver,” MASH is a condition marked by an overabundance of fat in the liver, causing inflammation and harm. It can occur regardless of alcohol use and poses a considerable risk of advancing to hepatitis, liver cirrhosis, and liver cancer. The prevalence of this condition has been continuously rising, especially in developed nations such as South Korea.

As per the Korea Health Industry Development Institute, the worldwide count of individuals with MASH is projected to be roughly 120 million. Furthermore, the U.S. National Institutes of Health (NIH) reports that between 1.5% and 6.5% of adult Americans are affected by MASH, with approximately 24% considered to be at high risk.

The causes of MASH are usually complicated, which makes developing effective treatments particularly difficult. Clinical studies are also known to be very challenging, as they have historically involved obtaining clinical data via invasive liver biopsies, commonly called tissue analyses.

The circumstances have recently started to evolve. The U.S. Food and Drug Administration (FDA) is taking steps to ease the standards for clinical trials evaluating new MASH medications. It has revealed intentions to widely use non-invasive tests (NIT) as assessment tools. This change is anticipated to quicken the arrival of new players in the industry’s competition to create innovative therapies.

Metavigil, a division of DongaST, validated the effectiveness and safety of DA-1241 via an international Phase 2 study. DA-1241 mainly targets GPR119, a receptor present in pancreatic beta cells and K-cells and L-cells within the small intestine. Stimulation of GPR119 enhances the release of hormones like insulin and GLP-1, helping control blood sugar levels and reducing hunger.

For the main assessment measure, blood test results were utilized. Participants who received 100 mg of DA-1241 demonstrated a notable decrease in liver damage indicators at both the 4th and 8th weeks when compared to the placebo group. In the secondary evaluation measures, which included non-invasive testing techniques, enhancements were noted in markers associated with fatty liver and liver fibrosis.

In early June, Metavigil shared research results at the American Diabetes Association (ADA 2025) regarding the simultaneous use of DA-1241 and efruxifermin. Efruxifermin is a medication that replicates the function of FGF21, a metabolic hormone generated in the liver. The study indicated that the combination treatment led to more significant enhancements in liver damage indicators and cholesterol levels than DA-1241 alone.

The market for MASH treatments is expanding quickly. As per the global pharmaceutical market research company EvaluatePharma, the worldwide MASH treatment market was estimated to be about $180 million (248.3 billion South Korean won) in the previous year. It is expected to reach approximately $9.26 billion (12.776 trillion South Korean won) by 2030.