Yu LY, Zhang XF. Beyond efficacy: Insights from the norursodeoxycholic acid phase III trial in metabolic dysfunction-associated steatotic liver disease. World J Hepatol 2026; 18(8): 117543 [DOI: 10.4254/wjh.117543]
Corresponding Author of This Article
Xian-Feng Zhang, MD, PhD, Chief Physician, Department of Endocrinology & Metabolism, Affiliated Hangzhou First People’s Hospital, Westlake University School of Medicine, No. 261 Huansha Road, Hangzhou 310006, Zhejiang Province, China. zxf2541@zju.edu.cn
Research Domain of This Article
Endocrinology & Metabolism
Article-Type of This Article
editorial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Hepatol. Aug 27, 2026; 18(8): 117543 Published online Aug 27, 2026. doi: 10.4254/wjh.117543
Beyond efficacy: Insights from the norursodeoxycholic acid phase III trial in metabolic dysfunction-associated steatotic liver disease
Ling-Ying Yu, Xian-Feng Zhang
Ling-Ying Yu, Xian-Feng Zhang, Department of Endocrinology & Metabolism, Affiliated Hangzhou First People’s Hospital, Westlake University School of Medicine, Hangzhou 310006, Zhejiang Province, China
Author contributions: Yu LY reviewed the literature and write the manuscript; Zhang XF conceptualized and outlined the overall editing framework of the manuscript, and conducted a comprehensive literature review; all authors have read and approved the final manuscript.
AI contribution statement: AI was only used to polish some sentences. To reduce the word count of the summary, AI was used to abbreviate it.
Supported by Zhejiang Provincial Traditional Chinese Medicine Science and Technology Project, No. 2025ZL454; Zhejiang Provincial Medical and Health Science and Technology Program Project, No. 2025KY1092; and the Construction Fund of Key Medical Disciplines of Hangzhou, Clinical Research and Evaluation, No. 2025HZGF04.
Conflict-of-interest statement: All authors declare that they have no conflict of interest to disclose.
Corresponding author: Xian-Feng Zhang, MD, PhD, Chief Physician, Department of Endocrinology & Metabolism, Affiliated Hangzhou First People’s Hospital, Westlake University School of Medicine, No. 261 Huansha Road, Hangzhou 310006, Zhejiang Province, China. zxf2541@zju.edu.cn
Received: December 10, 2025 Revised: December 26, 2025 Accepted: January 29, 2026 Published online: August 27, 2026 Processing time: 251 Days and 18.6 Hours
Abstract
The therapeutic landscape for metabolic dysfunction-associated steatotic liver disease (MASLD) is undergoing rapid transformation with recent drug approvals. This editorial contextualizes a recent phase III trial of norursodeoxycholic acid within this dynamic progress. Panuganti et al recently published a study in World Journal of Hepatology, while demonstrating significant alanine aminotransferase normalization and FibroScan-based liver stiffness improvement, the trial’s short duration (24 weeks), reliance on non-invasive endpoints, and absence of histological confirmation underscore persistent challenges in MASLD drug development.
Core Tip: The phase III trial of norursodeoxycholic acid (norUDCA) in metabolic dysfunction-associated steatotic liver disease reflects broader methodological challenges in the field: Short duration, reliance on non-invasive surrogate endpoints, and high placebo response rates. While norUDCA’s mechanism and safety profile differ from newly approved agents, its future role may be further evaluated.
