First Half 2026 Recap: Hepatology

The first half of 2026 marked a transformative period in hepatology, with major regulatory milestones, pivotal late-stage clinical trial results, and continued innovation across viral hepatitis, metabolic liver disease, and rare liver disorders. The US Food and Drug Administration (FDA) approved the first therapy for chronic hepatitis delta virus (HDV) infection and the first treatment specifically indicated for cholestatic pruritus in primary biliary cholangitis (PBC), while multiple investigational therapies advanced toward approval.

Momentum was especially strong in chronic viral hepatitis. Bepirovirsen continued to build on promising phase 3 data demonstrating functional cure in chronic hepatitis B (HBV), ultimately earning FDA Breakthrough Therapy designation and Priority Review. Meanwhile, bulevirtide became the first FDA-approved treatment for chronic HDV infection, and investigational therapies such as brelovitug delivered encouraging clinical data that could further expand treatment options.

Progress also continued in metabolic dysfunction-associated steatohepatitis (MASH), where novel therapies and regulatory designations reinforced the field's shift toward disease modification. At the same time, advances in gene-editing technologies highlighted the potential for one-time treatments targeting the underlying cause of alpha-1 antitrypsin deficiency (AATD).

Below is a look at the biggest hepatology developments from the first half of 2026.

Pemvidutide Gets Breakthrough Therapy Designation for MASH

On January 5, 2026, the FDA granted Breakthrough Therapy designation to pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of patients with MASH. The decision was supported by 24-week data from the IMPACT phase 2b trial demonstrating statistically significant MASH resolution without worsening of fibrosis, along with meaningful improvements in liver fat and noninvasive markers of fibrosis and hepatic inflammation.

Bepirovirsen Advances Toward Approval for Chronic Hepatitis B

The first half of 2026 represented a landmark period for bepirovirsen. In January, GSK announced positive phase 3 B-Well 1 and B-Well 2 trial results showing statistically significant and clinically meaningful functional cure rates in more than 1800 patients with chronic HBV.

Momentum continued in April when the FDA accepted the therapy's New Drug Application for Priority Review, granted Breakthrough Therapy designation, and assigned an October 26, 2026, PDUFA action date. In May, detailed phase 3 results published in the New England Journal of Medicine and presented at EASL showed bepirovirsen achieved a 19% functional cure rate, reinforcing its potential to become the first therapy capable of producing clinically meaningful functional cure in chronic HBV.

Bulevirtide Receives Historic First FDA Approval for Chronic Hepatitis Delta

On May 22, 2026, the FDA approved bulevirtide (Hepcludex) for adults with chronic HDV infection without cirrhosis or with compensated cirrhosis, making it the first FDA-approved therapy for chronic HDV infection. Approved under the Accelerated Approval pathway based on results from the phase 3 MYR301 trial, the first-in-class entry inhibitor represents a major milestone for a disease that previously lacked approved treatment options in the United States.

Inside the AZURE Program of Brelovitug for Hepatitis D, With Tatyana Kushner, MD

The HDV pipeline also advanced during the first half of the year. In April, Mirum Pharmaceuticals announced positive phase 2b AZURE-1 results for brelovitug, an investigational monoclonal antibody targeting hepatitis B surface antigen. At week 24, 100% of patients receiving 300 mg weekly and 75% receiving 900 mg every 4 weeks achieved virologic response, compared with no responses in the delayed-treatment group. Additional insights into the ongoing phase 3 AZURE program also highlighted the therapy's potential role in future HDV management.

FDA Approves Linerixibat as First Treatment for Cholestatic Pruritus in PBC

On March 19, 2026, the FDA approved linerixibat (Lynavoy) for cholestatic pruritus in adults with PBC, making it the first medication approved in the United States specifically for this indication. The approval was based on results from the phase 3 GLISTEN trial, which demonstrated rapid, significant, and sustained improvements in pruritus and itch-related sleep interference compared with placebo.

FDA Grants Priority Review to Saroglitazar NDA for Primary Biliary Cholangitis

On May 28, 2026, the FDA granted Priority Review to the New Drug Application for saroglitazar for adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) or are unable to tolerate UDCA. The application was assigned a PDUFA target action date of November 27, 2026, positioning the therapy as a potential new treatment option for patients with limited alternatives.