Hepatology Month in Review: April 2025

April brought a mix of progress and persistent challenges to the field of hepatology.

The US Food and Drug Administration (FDA)’s approval of a new maralixibat tablet formulation for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC) offered expanded treatment flexibility for patients with rare cholestatic liver diseases, while semaglutide took center stage in metabolic dysfunction–associated steatohepatitis (MASH) with new phase 3 ESSENCE trial data published in The New England Journal of Medicine, reinforcing its promise as a metabolic liver disease therapy.

Meanwhile, multiple studies highlighted the mounting impact of alcohol use and obesity on liver health—particularly in young women— underscoring the urgent need for more targeted research and interventions. In primary biliary cholangitis (PBC), new insights into biomarker trajectories and care access pointed to substantial gaps and unmet needs that remain in disease monitoring and management.

Check out this April 2025 hepatology month in review for a recap of HCPLive’s coverage of the top hepatic news and research from the past few weeks:

Hepatic FDA News and Pipeline Updates

FDA Approves Maralixibat (Livmarli) Tablet for Alagille Syndrome, PFIC

In the sole regulatory approval of the month, the FDA approved a new tablet formulation of maralixibat (Livmarli) for the treatment of cholestatic pruritus in patients with ALGS and PFIC.

According to a press release from Mirum Pharmaceuticals, maralixibat tablets are planned to be available in June through Mirum Access Plus. In addition to its already approved indications in ALGS and PFIC, maralixibat is being evaluated in the phase 3 EXPAND study in additional settings of cholestatic pruritus.

Semaglutide Improves Steatohepatitis, Fibrosis in Phase 3 MASH Trial

Data from part 1 of the phase 3 ESSENCE trial of semaglutide in patients with MASH and stage 2/3 fibrosis were published in The New England Journal of Medicine and highlight the GLP-1 RA’s safety and efficacy in this patient population.

Results from the planned interim analysis at week 72 involving the first 800 patients showed once-weekly semaglutide 2.4 mg outperformed placebo for resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening of steatohepatitis, the primary endpoints of part 1 of the trial.

Related: Diabetes Dialogue: Semaglutide for MASH in ESSENCE Trial, With Arun Sanyal, MD

Alcohol, Obesity, and Liver Health

Alcohol Use Disorder Pharmacotherapy May Improve Liver-Related Outcomes

Findings from this scoping review suggest a potential association between alcohol use disorder pharmacotherapy and improved hepatic outcomes in patients with alcohol-related liver disease, but research on this topic remains limited.

“Our scoping review demonstrates there are limited studies exploring the association between AUD pharmacotherapy and ALD,” wrote investigators. “Despite the significance of pharmacotherapy in treating AUD there remains a substantial gap in research within this area. Moving forward, further prospective studies need to be completed studying this association.”

Binge Drinking Rates Increasing Among Young Female Adults, Study Finds

Leveraging National Survey on Drug Use and Health data from 2017-2019 and 2021-2023, findings from this study highlight notable fluctuations in binge and heavy drinking patterns relative to historical trends. Specifically, results showed past-month binge drinking rates were greater among young adult females than males during the 2021-2023 period, reversing 2017-2019 patterns, whereas males in other age groups continued to binge and heavy drink at higher rates than females.

Obesity Increases Mortality, Complication Risk in Alcohol-Associated Hepatitis

Findings from this study shed light on the potential benefits of weight loss for patients with alcohol-associated hepatitis and obesity, highlighting a heightened risk of mortality, complications, and healthcare costs among hospitalized patients with Class 3 obesity relative to those with BMI < 30.

PBC Research

Prolonged Hepatic Biomarker, Fibrosis Score Elevation Linked to Poor PBC Prognosis

Increasing magnitude and duration beyond established thresholds of alkaline phosphatase, alanine aminotransferase; aspartate aminotransferase; total bilirubin; aspartate aminotransferase/platelet ratio index; and fibrosis-4 are associated with an increased risk of hospitalization for hepatic decompensation, liver transplantation, or death in patients with PBC, according to findings from this study.

Study Highlights Regional Variability in PBC Prevalence, Limited Specialist Care Access

Findings from this recent study shed light on the population-based estimated prevalence of PBC in the US. The adjusted prevalence of adult patients with PBC in 2021 was 40.9 per 100,000 persons, with the greatest absolute number of patients with PBC in heavily populated urban areas. However, the prevalence adjusted for population size was greatest in some rural areas, and notable variations were observed in specialist care.