Tegoprazan vs lansoprazole: can a P-CAB prevent NSAID-related peptic ulcers over 24 weeks?

Source

Source: Extracted PubMed-style record for a Gut Liver online-ahead-of-print phase III randomized, double-blind, active-controlled multicenter trial of tegoprazan for prevention of NSAID-induced peptic ulcer. The publication reports ClinicalTrials.gov identifier NCT04840550.

Tegoprazan matched lansoprazole for preventing NSAID-related peptic ulcers over 24 weeks, with comparable safety in a Phase III randomized trial.

Design

Phase III randomized, double-blind, active-controlled, multicenter trial

Population

Patients continuing long-term NSAID therapy

Treatment

Tegoprazan 25 mg

Comparator

Lansoprazole 15 mg

Duration

Up to 24 weeks

Why it matters

Long-term NSAID therapy can increase peptic ulcer risk. Acid suppression is commonly used as gastroprotection for patients who need ongoing NSAID treatment.

24 wk Clinically relevant prevention window for NSAID-associated gastroduodenal ulcers

Central finding

Primary endpoint met

Non-inferior Tegoprazan 25 mg vs lansoprazole 15 mg for prevention of NSAID-induced gastroduodenal ulcers at week 24

p=0.0004 Non-inferiority test

Tegoprazan

25 mg

P-CAB strategy for gastroprotection

Lansoprazole

15 mg

Active PPI comparator

392 Patients randomized

269 Patients included in the per-protocol analysis

Efficacy results: endpoint-by-endpoint

Endpoint	Timepoint	Key quantitative result	Interpretation
Gastroduodenal ulcer prevention	Week 24	p=0.0004 Non-inferiority of tegoprazan vs lansoprazole	Primary endpoint met
Heartburn-free rate	Week 12	Higher with tegoprazan	Tegoprazan showed a higher heartburn-free rate; no per-arm percentage was provided in the brief.
Other gastrointestinal symptom-free rates	During follow-up	Not significantly different between groups	Symptom outcomes were broadly comparable aside from week-12 heartburn-free rate.

Safety profile

Adverse drug reactions Comparable ADR profile was similar between tegoprazan and lansoprazole groups in this Phase III study.

Serious adverse events Comparable Serious adverse events were comparable between the two active-treatment arms.

Numbers to know

392 Randomized patients

269 Per-protocol analysis set

p=0.0004 Non-inferiority for week-24 gastroduodenal ulcer prevention

25 mg Tegoprazan dose

15 mg Lansoprazole comparator dose

12 wk Heartburn-free rate favored tegoprazan at this timepoint

Takeaway: Position tegoprazan as a clinically effective alternative to lansoprazole for gastroprotection in patients requiring long-term NSAID therapy, with similar tolerability and safety in this Phase III study.

AbbreviationsQuick

ADRs=adverse drug reactions; NSAIDs=nonsteroidal anti-inflammatory drugs; SAEs=serious adverse events.

Bibliography1

Kim SG, Kim TO, Jung SW, Min BH, Oh JH, Kim HS, et al. A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs. Gut Liver. 2026 Jun 22. Online ahead of print. PMID: 42325011. (DOI: 10.5009/gnl260057)

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