Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

Phase 4 Completed 60 enrolled Tanta University

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to investigate the safety and efficacy of using ketotifen in patients with NAFLD patients without cirrhosis

Timeline

Start: 2023-05-20
Primary completion: 2025-03-01
Completion: 2025-03-01

Outcome

Met primary endpoint

paper Ketotifen treatment resulted in significant improvements in hepatic steatosis and disease activity compared with vitamin E, including lower steatosis and FibroScan-AST (FAST) score. PMID 42039690 ↗

Publications

Aldossary KM, Talkhan H, Abdulelah FM, Kotkata FA, Elmorsi YM, Habba E, Eltantawy N, Mourad SA, Hamza E, Sami HM, Ali KABK, Elberri EI, Bahaa MM. Immunomodulatory and Anti-Inflammatory Effects of Ketotifen Versus Vitamin E in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Pilot Study. Drug Des Devel Ther. 2026 Apr 21;20:593561. doi: 10.2147/DDDT.S593561. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketotifen	Small molecule	—	—
Subject	Vitamin E	Other / unclassified	—	—