Fexuprazan 20mg Phase 4 Trial for NSAID-Induced Peptic Ulcer Prevention
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registered a Phase 4 clinical trial (NCT07533266) for Fexuprazan 20mg as a preventive treatment for NSAID-induced peptic ulcers. The study will enroll participants using NSAIDs and compare the non-inferiority of Fexuprazan 20mg to Lansoprazole 15mg over 8 weeks. The trial is listed with an estimated start date and targets completion by April 2026.
What changed
A Phase 4 clinical trial for Fexuprazan 20mg has been registered on ClinicalTrials.gov (NCT07533266). The study will evaluate whether Fexuprazan 20mg is non-inferior to Lansoprazole 15mg in preventing peptic ulcers in patients using NSAIDs. Participants will receive either Fexuprazan with placebo or Lansoprazole with placebo for comparison.
For pharmaceutical sponsors and clinical investigators, this represents an active Phase 4 post-marketing study in the proton pump inhibitor space. Healthcare providers treating patients on long-term NSAID therapy may wish to be aware of emerging preventive options being studied. No compliance obligations or regulatory deadlines arise from this registration itself.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer
Phase 4 NCT07533266 Kind: PHASE4 Apr 16, 2026
Abstract
The study aims to demonstrate the preventive effect of Fexuprazan 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of Fexuprazan 20 mg.
Conditions: NSAID (Non-Steroidal Anti-Inflammatory Drug)
Interventions: Fexuprazan 20mg, Lansoprazole 15 mg placebo, Lansoprazole 15 mg, Fexuprazan 20mg placebo
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