Publication Name	World Journal of Hepatology
Manuscript ID	113658
Country	India

Category	Gastroenterology & Hepatology
Manuscript Type	Clinical Trials Study
Article Title	Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients
Manuscript Source	Unsolicited Manuscript
All Author List	Veerendra Kumar Panuganti, Chandrasekhar Varma Alluri, Javeed Mohammad, Mamatha Reddy Dundigalla, Pavan Kumar Madala, Sanyasirao KSSVV and Althaf Shaik
Funding Agency and Grant Number	Funding Agency Grant Number Shilpa Medicare Limited, Hyderabad, Telangana, India
Corresponding Author	Veerendra Kumar Panuganti, Head, PhD, 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
Key Words	24-norursodeoxycholic acid; Fatty liver; Liver diseases; Steatosis; Fibrosis; Metabolic dysfunction-associated steatotic liver disease; Nonalcoholic fatty liver disease
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 (SAEs) reported. All adverse events (AEs) 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. 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 (SAEs) reported. All adverse events (AEs) 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.
Citation	Panuganti VK, Alluri CV, Mohammad J, Dundigalla MR, Madala PK, KSSVV S, Shaik A. Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients. World J Hepatol 2025; In press

Received	2025-09-01 10:04
Peer-Review Started	2025-09-01 10:07
To Make the First Decision
Return for Revision	2025-09-12 06:45
Revised	2025-09-24 19:13
Second Decision	2025-11-27 02:41
Accepted by Journal Editor-in-Chief
Accepted by Executive Editor-in-Chief	2025-11-27 05:00
Articles in Press	2025-11-27 05:00
Publication Fee Transferred	2025-10-01 12:11
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Typeset the Manuscript

ISSN	1948-5182 (online)
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