K-CAB Tab (tegoprazan) / Luoxin Pharma, RaQualia, Korea Kolmar, Sebela - LARVOL DELTA

Efficacy of Potassium-Competitive Acid Blockers Versus Proton Pump Inhibitors in Eradication Regimens for Clarithromycin-Resistant Helicobacter pylori: A Systematic Review and Meta-Analysis. (PubMed, Pathogens) - "P-CAB-based eradication regimens are significantly more effective than PPI-based comparators in patients with clarithromycin-resistant H. pylori infection. Further well-designed studies are warranted to determine the optimal antibiotic combinations, treatment durations, and regional applicability of these regimens."

Clinical • Journal • Retrospective data • Review • Infectious Disease

Ultra-Rapid Heartburn Relief and Early Mucosal Healing: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing P-CABs and PPIs (ACG 2026) - "These findings are further supported by preliminary data from the US Phase 3 TRIUMpH-EE trial (Sebela Pharmaceuticals, presented DDW 2026), which reported superior Week 2 and Week 8 healing for tegoprazan versus lansoprazole across all LA grades; full peer-reviewed results are pending. Limitations include k=5 RCTs, predominance of Asian populations for vonoprazan data, moderate Day 1 heterogeneity likely reflecting P-CAB agent and population differences, and conference-presentation status of corroborating US data. Larger confirmatory trials and US-specific subgroup analyses will be essential before guideline modification."

Retrospective data • Review • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • CYP2C19

Tegoprazan Provides Superior Healing and Maintenance of Conclusive Gastroesophageal Reflux Disease Per Lyon Consensus Endoscopic Criteria Than Lansoprazole: Post-Hoc Analysis of the TRIUMpH Randomized Controlled Trial (ACG 2026) - P3 | "There were no differences in age, gender, race/ethnicity and LA EE grades between patients randomized to tegoprazan (n=623, mean age 53 yrs, 53% female, 67% conclusive GERD) and lansoprazole (n=622, mean age 54 yrs, 52% female, 64% conclusive GERD). In the modified intention-to-treat (m-ITT) population, rates of healed EE were higher with tegoprazan compared to lansoprazole among patients with conclusive GERD per Lyon 2.0 (LA grades B-D) at week 2 (75.4% vs 60.7%, p< 0.0001) and cumulatively by week 8 (83.4% vs 72.7%, p=0.0005), while no difference was observed between groups at both time points for inconclusive GERD (LA grade A). Similar results were found in the per protocol (PP) analyses (Table)."

Clinical • Retrospective data • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Comparative Efficacy and Safety of Pharmacological Therapies for Non-Erosive Reflux Disease: A Systematic Review and Network Meta-Analysis (ACG 2026) - "Seven nodes were defined: PPI monotherapy, H2RA monotherapy, PCAB (vonoprazan/tegoprazan), alginate monotherapy, alginate combined with PPI, PPI with non-alginate adjunct, and placebo/antacid (reference). Forty-six RCTs (14,218 participants) were included. For heartburn resolution (I²=84.4%), PPI monotherapy was the sole intervention achieving significance versus placebo/antacid (RR 1.65 [95% CI 1.29-2.10]; P-score 0.68); PPI with adjunct therapy also attained significance (RR 1.83 [1.02-3.28]; P-score 0.76). Alginate combined with PPI ranked second by P-score (0.72; RR 1.82 [0.79-4.23]) without significance, reflecting limited trial data."

Retrospective data • Review • Gastroenterology • Gastroesophageal Reflux Disease

Tegoprazan Significantly Improves Heartburn and Regurgitation in a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Patients With Non‑Erosive Reflux Disease (ACG 2026) - "Abstract text will be released on Sunday, October 11, 2026, at 12:00 pm CT (1:00 pm ET) when the ACG 2026 embargo lifts."

Clinical • P3 data • Gastroenterology • Gastroesophageal Reflux Disease

Comment on "Efficacy and Safety of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials". (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data • Infectious Disease

Comparative effectiveness of genotype-guided and empirical bismuth-containing quadruple therapy for Helicobacter pylori eradication: a retrospective study. (PubMed, Front Pharmacol) - "All regimens comprised bismuth potassium citrate 2.6 g, a proton pump inhibitor (PPI, esomeprazole 20 mg or ilaprazole 5 mg) or a potassium-competitive acid blocker (P-CAB, keverprazan 20 mg or tegoprazan 50 mg), and antibiotics selected from amoxicillin, clarithromycin, levofloxacin, furazolidone, tetracycline, metronidazole, or doxycycline. Dual clarithromycin and levofloxacin resistance and alcohol consumption remained key determinants of treatment failure even with genotype-guided therapy. However, the precision of estimates for single-drug resistance subgroups was limited by small sample sizes and should be interpreted cautiously."

HEOR • Journal • Retrospective data • Addiction (Opioid and Alcohol) • Infectious Disease

Short-Term Efficacy of Tegoprazan Compared With Esomeprazole in Patients With Non-Erosive Reflux Disease and Nocturnal Heartburn Symptoms: A Double-Blind, Randomized Controlled Trial. (PubMed, Korean J Helicobacter Up Gastrointest Res) - "The time to the first nocturnal heartburn-free interval was shorter with tegoprazan than with esomeprazole (2.0 days vs. 2.5 days, p=0.529); however, the difference was not significant. Tegoprazan demonstrated non-inferiority to esomeprazole with respect to nocturnal heartburn-free days and may provide more rapid relief from nocturnal heartburn symptoms."

Journal • Gastroenterology • Gastroesophageal Reflux Disease

A Study to Evaluate Tegoprazan as a Diagnostic Tool for GERD (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: HK inno.N Corporation

New P4 trial • Gastroenterology • Gastroesophageal Reflux Disease

Safety and efficacy of tegoprazan in patients treated with dual antiplatelet therapy after coronary stenting for acute myocardial infarction. (PubMed, Sci Rep) - "After propensity-score matching, tegoprazan was consistently associated with lower risks of GI bleeding (hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.54-0.98, P = 0.04) and major bleeding (HR 0.69, 95% CI 0.49-0.98, P = 0.04), without increasing the risk of MACCEs (HR 0.86, 95% CI 0.59-1.26, P = 0.45) at 1 year. In patients with AMI treated with DAPT, tegoprazan was associated with a significantly lower GI bleeding risk versus PPIs, without increasing ischemic events."

Journal • Cardiovascular • Myocardial Infarction

Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs (clinicaltrials.gov) - P3 | N=392 | Completed | Sponsor: HK inno.N Corporation | Recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Peptic Ulcer

Comment on Letter to the Editor "Efficacy and Safety of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Infection: A Systematic Review and Meta-Analysis". (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data • Infectious Disease

Beyond Dual Therapy: Rethinking Tegoprazan-Amoxicillin for H. pylori. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal

Methodological Considerations Regarding the Meta-Analysis of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data • Infectious Disease

Comment on: "Efficacy and Safety of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials". (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data • Infectious Disease

CKD risk with tegoprazan versus proton pump inhibitors. (PubMed, Nephrol Dial Transplant) - "In this large real-world analysis, PPI initiation was associated with a higher rate of newly coded CKD than tegoprazan initiation. These findings provide comparative kidney safety data and suggest that risk of kidney injury may be one consideration, alongside efficacy and cost, when prolonged acid suppression is required."

Journal • Chronic Kidney Disease • Nephrology • Renal Disease

Letter to the Editor on: Efficacy and Safety of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data • Infectious Disease

Beyond the Meta-Analysis: Reconsidering Class Effects, Resistance Surveillance, and Dosing Optimization in Tegoprazan-Amoxicillin Dual Therapy. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data

Response to "Efficacy and Safety of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials". (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Retrospective data • Infectious Disease

Pharmacokinetic and Pharmacodynamic Characteristics of Tegoprazan According to Helicobacter pylori Infection Status. (PubMed, J Gastroenterol Hepatol) - "The presence of H. pylori did not have a clinically significant effect on tegoprazan's PK and tolerability, but significantly enhanced its intragastric acid suppression efficacy."

Journal • PK/PD data • Infectious Disease

KIDNEY SAFETY VALIDATION OF TEGOPRAZAN IN THE CONTEXT OF REAL-WORLD PPI-ASSOCIATED KIDNEY RISK (UEGW 2026) - No abstract available

Clinical • Real-world • Real-world evidence

EFFICACY AND SAFETY OF TEGOPRAZAN-BASED REGIMENS FOR HELICOBACTER PYLORI ERADICATION: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS OF 13 RANDOMIZED CONTROLLED TRIALS (UEGW 2026) - No abstract available

Retrospective data • Review • Infectious Disease

EFFICACY AND SAFETY OF TEGOPRAZAN-BASED DUAL, TRIPLE, AND QUADRUPLE THERAPIES IN FIRST-LINE HELICOBACTER PYLORI ERADICATION: A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL (UEGW 2026) - No abstract available

Clinical • Infectious Disease

OPTIMIZED DUAL THERAPY WITH TEGOPRAZAN AND HIGH-DOSE AMOXICILLIN FOR HELICOBACTER PYLORI ERADICATION: A REAL-WORLD PILOT STUDY (UEGW 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease

TEGOPRAZAN-AMOXICILLIN DUAL THERAPY VERSUS ESOMEPRAZOLE-BASED BISMUTH QUADRUPLE THERAPY FOR FIRST-LINE HELICOBACTER PYLORI ERADICATION: A PROSPECTIVE, RANDOMIZED, MULTICENTER, SUPERIORITY TRIAL (UEGW 2026) - No abstract available

Clinical • Head-to-Head • Infectious Disease