Q2 2025 Recap: Hepatology News and Updates

The second quarter of 2025 delivered a wave of meaningful developments in hepatology—from FDA approvals that expand therapeutic options to promising pipeline data that could shape the future of care across a spectrum of liver diseases and the launch of a new hepatology podcast hosted by some of the field’s leading experts.

Here’s a recap of what made headlines in Q2 of 2025:

Hepatic Regulatory Approvals

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

On April 14, 2025, the FDA approved a new tablet formulation of maralixibat (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).

“The approval of LIVMARLI in tablet form provides a meaningful additional treatment option for patients with ALGS and PFIC. It allows flexibility for patients and physicians, with the liquid dosing used by the youngest patients and a convenient one-tablet per dose option for older patients,” said Peter Radovich, president and chief operating officer at Mirum. “We have had tremendous success with LIVMARLI since its launch and we hope that the availability of the tablet will provide convenience that positively impacts patients’ lives.”

FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV

On June 11, 2025, the FDA approved a label expansion for AbbVie’s glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. With the decision, glecaprevir/pibrentasvir became approved for the treatment of adults and pediatric patients ≥ 3 years of age with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.

The approval was supported by data from the phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of glecaprevir/pibrentasvir 8-week treatment in adults with acute HCV infection.

Key Pipeline Updates

Pemvidutide Shows Significant MASH Effects, Weight Loss at 24 Weeks in Phase 2b IMPACT Trial

On June 26, 2025, Altimmune announced the phase 2b IMPACT trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants and fibrosis improvement without worsening of MASH in up to 34.5% of participants in intent-to-treat analyses as well as weight loss of up to 6.2% at 24 weeks with no plateauing. Of note, the data make pemvidutide the first product candidate to demonstrate significant MASH effects and weight loss at 24 weeks.

Hydronidone Meets Primary Endpoint in Phase 3 Hepatitis B Trial

ON May 22, 2025, Gyre Therapeutics announced hydronidone met the primary endpoint for ≥1-stage regression in liver fibrosis compared to placebo in a pivotal phase 3 trial evaluating its efficacy and safety for the treatment of liver fibrosis in patients with chronic hepatitis B in China. Based on these data, Gyre indicated plans to file an investigational new drug (IND) application in the third quarter of 2025. Pending IND clearance, the company will look to initiate a phase 2 trial in the US evaluating hydronidone for the treatment of MASH-associated fibrosis in the second half of 2025.

Efruxifermin Shows Potential for Fibrosis Reduction in Phase 2b MASH Cirrhosis Trial

Efruxifermin, a bivalent fibroblast growth factor 21 (FGF21) analogue being developed for the treatment of MASH, failed to significantly reduce fibrosis without worsening of MASH at 36 weeks in the phase 2b SYMMETRY trial. However, further analysis revealed the 50 mg dose of efruxifermin may have possible benefit on fibrosis reduction at 96 weeks. Notably, efruxifermin also appeared to be associated with improvements in MASH-related histologic findings, noninvasive markers of liver injury and fibrosis, and markers of glucose and lipid metabolism.

Semaglutide Improves Steatohepatitis, Fibrosis in Phase 3 MASH Trial

Data from part 1 of the phase 3 Effect of Semaglutide in Subjects with Non-cirrhotic Non-alcoholic Steatohepatitis (ESSENCE) trial highlight the safety and efficacy of semaglutide for the treatment of patients with MASH and stage 2/3 fibrosis. Results 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 ESSENCE data may represent key findings for patients in the treatment of MASH, which is estimated to affect about one in 20 adults in the US,” said Arun Sanyal, MD, ESSENCE lead author and director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University. “By treating both liver disease and its metabolic causes, semaglutide offers a promising new approach for millions of patients.”

Phase 2 ELMWOOD Data for Elafibranor in PSC, with Cynthia Levy, MD

Data from the phase 2 ELMWOOD study of elafibranor in patients with primary sclerosing cholangitis (PSC) shed light on the peroxisome proliferator-activated receptor (PPAR) agonist’s safety and tolerability in this patient population, suggesting elafibranor may be a potential treatment option for PSC, a chronic liver disease for which none currently exist.

HCPLive Launches Flagship Hepatology Podcast

Liver Lineup: Updates & Unfiltered Insights

Q2 saw the launch of HCPLive’s first hepatology podcast, Liver Lineup: Updates & Unfiltered Insights. Hosted by Drs. Nancy Reau and Kim Brown, the series dives into the cutting edge of liver disease research, clinical care, and real-world practice. Intended for hepatologists, gastroenterologists, and other clinicians managing liver disease, Liver Lineup will unpack the latest research, debate emerging controversies, and spotlight developments that could shape — or sharpen — day-to-day practice, all with unfiltered perspective and clarity.

In their first 2 episodes, Reau and Brown break down 7 of the top abstracts presented at the 2025 European Association for the Study of the Liver (EASL) Congress.

Liver Lineup: New MASLD and PBC Agents, PEth Testing, and HBV Functional Cure at EASL 2025

Liver Lineup: Advances in MASH, PSC, and PBC Care at EASL 2025