Novel treatment option to prevent NSAID-induced peptic ulcers

Fexuprazan may be a viable alternative to lansoprazole for the prevention of non-steroid anti-inflammatory drug (NSAID)-induced peptic ulcers, findings of a phase 3 study indicated.

Dr Song Baek (Daewoong Pharmaceutical Co Ltd, South Korea) and co-investigators compared the efficacy and safety of fexuprazan, a novel potassium-competitive acid blocker, with that of lansoprazole, a standard-of-care proton pump inhibitor (PPI), for the prevention of NSAID-induced peptic ulcers [1]. The study included patients with a musculoskeletal disease who required prolonged treatment with celecoxib, naproxen, or meloxicam. The 423 participants were randomised 1:1 to fexuprazan, 20 mg daily, or to lansoprazole, 15 mg daily. At week 24, the research team looked primarily at the occurrence of peptic ulcers and gastroduodenal bleeding.

After 24 weeks of follow-up, upper gastrointestinal endoscopy revealed peptic ulcer rates of 1.2% and 2.8% in participants treated with fexuprazan and lansoprazole, respectively, meeting the non-inferiority margin of 8.2%. There were no cases of gastroduodenal bleeding at this timepoint. Dr Baek mentioned that symptoms, evaluated by the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM), were comparable between the study arms. Finally, adverse event rates were 8.6% for participants in the fexuprazan group and 4.8% for participants in the lansoprazole group (P=0.12).

“Fexuprazan appears to be a promising alternative to lansoprazole for the prevention of NSAID-induced peptic ulcers, given its non-inferiority to the standard-of-care drug and a comparable safety profile,” Dr Baek summarised.

1. Hong S, et al. Efficacy and safety of fexuprazan in prevention of NSAIDs-induced peptic ulcer compared with lansoprazole: randomised, double-blind, phase III trial. Abstract Sa1331, Digestive Disease Week 2025, 3–6 May 2025, San Diego, USA.

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Posted on 21 May 202526 September 2025