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Hepatology in July 2026: Odevixibat misses phase 3 primary endpoint, zabopegdutide shows early MASH benefit, plus a new Wilson disease NDA
July brought mixed trial results across hepatology, a new regulatory filing, and fresh data on gaps in patient awareness.
Odevixibat did not meet its primary endpoint in the phase 3 BOLD trial for biliary atresia, the largest disease-modification study conducted in the condition, while zabopegdutide showed early liver benefits in a phase 2 MASH trial within 12 weeks.
Monopar Therapeutics also initiated a rolling NDA submission for ALXN1840 in Wilson disease, a copper-dysregulation disorder with limited treatment options. Separately, a World Hepatitis Day survey found low public awareness of the link between chronic hepatitis B and liver cancer risk, and Stevan Gonzalez, MD, MS, outlined how primary care physicians and community screening programs can support earlier detection of chronic liver disease.
Below is a summary of the July 2026 stories in hepatology, covering a phase 3 trial readout, a new NDA filing, early MASH data, and expert guidance on detection and awareness.
Topline data from the phase 3 BOLD trial, the largest disease-modification study conducted in biliary atresia, showed odevixibat did not outperform placebo on its primary endpoint of native liver survival, though the drug's established safety profile from its approved indications held up.
New phase 2 data suggest zabopegdutide improved liver fat, liver stiffness, and fibrosis biomarkers within 12 weeks in adults with metabolic dysfunction-associated steatohepatitis (MASH), an active area of drug development.
Monopar Therapeutics initiated a rolling new drug application submission for ALXN1840, an investigational therapy targeting the copper dysregulation that drives Wilson disease, moving the candidate a step closer to a potential new option for this rare and often under-treated condition.
Released on World Hepatitis Day, a new survey found gaps in public understanding of chronic hepatitis B and its connection to liver cancer risk. Cary James discusses what the findings mean for ongoing hepatitis B elimination efforts and where awareness campaigns could be improved.
Stevan Gonzalez, MD, MS, discusses the role of earlier diagnosis in chronic liver disease outcomes and outlines how primary care physicians and community-based screening programs can support earlier detection.