Hepatitis B- Global Clinical Trial Landscape (2025)

Hepatitis B virus (HBV) is a highly contagious liver infection that can lead to both acute and chronic disease. While many individuals recover without lasting effects, chronic infections can persist for life. Despite the availability of vaccines and antiviral treatments, Hepatitis B remains a significant global health concern. Current clinical endpoints for chronic Hepatitis B (CHB) trials include viral suppression, HBsAg loss, and functional cure—defined as sustained HBsAg clearance with undetectable serum HBV DNA for at least six months. While achieving a complete cure remains elusive, novel therapeutic approaches are being explored. Emerging biomarkers such as HBV RNA and HBcrAg are also improving the precision of disease monitoring and treatment response assessment.

Asia-Pacific leads the global clinical trial landscape for Hepatitis B, with China, Hong Kong, South Korea, and Taiwan as key research hubs. Companies like Bluejay Therapeutics, Precision Biosciences, and Tune Therapeutics are at the forefront of developing next-generation therapies aimed at achieving a functional cure. As clinical trials advance, refining therapeutic endpoints and integrating novel treatment strategies are essential to transforming Hepatitis B management and ultimately achieving a cure.