Q3 2025 Recap: Hepatology News and Updates

The third quarter of 2025 brought a flurry of US Food and Drug Administration (FDA) news, notable changes in the primary biliary cholangitis (PBC) treatment landscape, and novel research on liver health, underscoring the rapidly evolving landscape in hepatology.

Metabolic dysfunction-associated steatotic liver disease (MASH) took center stage in the realm of regulatory updates with the approval of Novo Nordisk’s semaglutide (Wegovy) injection 2.4 mg and the acceptance of Echosens’ Letter of Intent for the qualification of LSM by VCTE (FibroScan) as a reasonably likely surrogate endpoint in clinical trials. Meanwhile, in PBC, the field lost an important second-line treatment option with the voluntary withdrawal of obeticholic acid (Ocaliva) from the US market.

In terms of hepatic research, new studies are providing additional insight into sex disparities in liver complication risk among patients with cirrhosis, the potential benefits of nontargeted hepatitis C virus (HCV) screening, the impact of pruritus on health-related quality of life (HRQoL) in PBC, and the benefits of adhering to a healthy diet and being physically active in the context of alcohol-attributable liver-related mortality risk.

Check out this recap of what made headlines in Q3 of 2025:

FDA Approves Semaglutide (Wegovy) Injection 2.4 mg for Noncirrhotic MASH

On August 15, 2025, the FDA approved Novo Nordisk’s semaglutide (Wegovy) injection 2.4 mg for the treatment of adults with MASH with moderate to advanced fibrosis, but not with cirrhosis, in conjunction with a reduced calorie diet and increased physical activity. The decision was based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly semaglutide 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis at week 72.

Related: Diabetes Dialogue: FDA Approves Semaglutide (Wegovy) for MASH

FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials

On September 8, 2025, the FDA’s Center for Drug Evaluation and Research, Office of New Drugs accepted Echosens’ Letter of Intent for the qualification of LSM by VCTE (FibroScan) as a reasonably likely surrogate endpoint in clinical trials for MASH. As stated in the Letter of Intent, which included official letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk, LSM by VCTE can predict the risk of all-cause mortality or liver-related events in patients with MASH.

Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market

On September 11, 2025, Intercept Pharmaceuticals announced its decision to voluntarily withdraw obeticholic acid (Ocaliva) from the US market for the treatment of PBC following a request from the FDA, The Agency additionally placed a clinical hold on all Intercept clinical trials conducted under a US IND involving obeticholic acid.

Male Cirrhosis Patients Face Greater Risk of Liver Complications Than Females

Leveraging data for > 400,000 adult patients from the Merative MarketScan Research Databases, this study highlights significant sex disparities in liver complication risk among patients with cirrhosis, including increased risks of hepatocellular carcinoma, liver transplantation, and decompensated cirrhosis among men compared with women.

Nontargeted Emergency Department HCV Screening Could Aid Infection Identification

Findings from the DETECT Hep C Trial suggest a nontargeted HCV screening approach may be preferable to targeted screening for identifying new HCV infections in emergency departments (EDs). Coined as the largest pragmatic clinical trial of HCV screening in EDs to date, the trial was conducted in 3 high-volume EDs at Denver Health Medical Center, Johns Hopkins Hospital, and the University of Mississippi Medical Center and found nontargeted HCV screening identified significantly more new diagnoses of HCV infection than targeted screening.

Pruritus Increases HRQoL Burden in PBC, Underscoring Need for Effective Treatments

Recent research suggests people with PBC and moderate-to-severe pruritus experience a greater HRQoL burden and reduced activity compared to those with mild-to-no pruritus. Specifically, those who reported experiencing pruritus experienced a significantly greater negative impact on HRQoL across a range of domains, including those related to itch, fatigue, and social and cognitive function. Of note, those with pruritus reported infrequent use of treatments targeting itch, with minimal or no relief.

Healthy Diet, Physical Activity Improve Alcohol-Related Liver Health

Findings from this study shed light on the benefits of adhering to a healthy diet and being physically active in the context of alcohol-attributable liver-related mortality risk, highlighting notable attenuations in this risk across all drinking patterns, including heavy and binge drinking.

Daily alcohol intake and binge drinking were independently associated with greater risks of liver-related mortality, but this risk was found to be reduced with healthy dietary patterns and increased physical activity. Of note, women achieved greater liver survival benefits than men.