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Beyond efficacy: Insights from the norursodeoxycholic acid phase III trial in metabolic dysfunction-associated steatotic liver disease
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
Revised: December 26, 2025
Accepted: January 29, 2026
Published online: August 27, 2026
Processing time: 251 Days and 18.6 Hours
Core Tip
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.