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©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Dec 27, 2025; 17(12): 113658
Published online Dec 27, 2025. doi: 10.4254/wjh.v17.i12.113658
Published online Dec 27, 2025. doi: 10.4254/wjh.v17.i12.113658
Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients
Veerendra Kumar Panuganti, Javeed Mohammad, Sanyasirao KSSVV, Althaf Shaik, Clinical Affair Division, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India
Chandrasekhar Varma Alluri, Mamatha Reddy Dundigalla, Medical Affairs Department, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India
Pavan Kumar Madala, Bioanalytical Laboratory, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India
Author contributions: Panuganti VK is responsible for conceptualization, design and conduct of trial, regulatory approvals, project management and also involved in statistical analysis, data interpretation and conclusive analysis, and overall execution of the study; Panuganti VK, Alluri CV, and Dundigalla MR has supported the original manuscript writing, editing and reviewing of the final draft; Mohammad J, KSSVV S, and Shaik A have supported the project administration activities; Madala PK has supported the bioanalytical testing and validation of analytical methods applied in the current research investigation. All the authors have read and approved the final manuscript.
Supported by Shilpa Medicare Limited, Hyderabad, Telangana, India.
Institutional review board statement: The study was approved by Supe Hospital Ethics Committee (approval No. 001/Nor-UDCA/SML/2023).
Clinical trial registration statement: The study was approved by all relevant ethics committee, regulatory authorities at all centers, and has been registered at Clinical Trials Registry-India, registration identification number is CTRI/2023/08/055982.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Panuganti VK reports and all the authors listed in the article are the employees of Shilpa Medicare Limited.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Veerendra Kumar Panuganti, PhD, Head, Clinical Affair Division, Shilpa Medicare Limited, Unit VII, Plot No. 79, Survey No. 125, IDA, Mallapur, Nacharam, Hyderabad 500076, Telangāna, India. veerendrap.frd@shilpamedicare.com
Received: September 1, 2025
Revised: September 24, 2025
Accepted: November 27, 2025
Published online: December 27, 2025
Processing time: 117 Days and 19.8 Hours
Revised: September 24, 2025
Accepted: November 27, 2025
Published online: December 27, 2025
Processing time: 117 Days and 19.8 Hours
Core Tip
Core Tip: This phase III trial demonstrated that norursodeoxycholic acid (norUDCA) 1500 mg significantly improved liver function in metabolic dysfunction-associated steatotic liver disease patients, with a majority of patients achieving alanine aminotransferase normalization and showing fibrosis regression on FibroScan. Notably norUDCA demonstrated favorable safety profile with no serious adverse events reported. All adverse events reported were mild or moderate in intensity and recovered over time. These findings highlight the norUDCA’s efficacy and safety addressing the need for more approved promising therapies in managing metabolic dysfunction-associated steatotic liver disease.