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

Effect of Tegoprazan on Tacrolimus and Mycophenolate Levels in Kidney Transplant Recipients: A Randomized Controlled Study Using a Smart Trial Platform. (PubMed, Pharmaceuticals (Basel)) - " Tegoprazan does not alter the blood trough levels of tacrolimus and mycophenolate during the 12-week follow-up in KTRs and has a similar impact on GI symptoms as pantoprazole. This study confirms the feasibility and safety of using a smart clinical trial system with remote monitoring for randomized trials."

Journal • Transplantation

Intravenous proton pump inhibitors vs oral potassium competitive acid blockers before endoscopic treatment of bleeding peptic ulcers. (PubMed, World J Gastrointest Endosc) - "Pre-endoscopic PCAB administration is more effective than PPI injection for upper gastrointestinal bleeding and may reduce ulcer bleeding mortality."

Journal • Gastroenterology • Peptic Ulcer

Comparing Proton Pump Inhibitors and Emerging Acid-Suppressive Therapies in Gastroesophageal Reflux Disease: A Systematic Review. (PubMed, Cureus) - "These studies examined the effectiveness of newer agents such as potassium-competitive acid blockers (P-CABs), including vonoprazan, fexuprazan, and tegoprazan, as well as the use of mucosal protective agents and varied PPI administration strategies (on-demand vs. continuous). On-demand PPI use showed similar outcomes to continuous use, suggesting it may be a viable option for certain patient populations. Overall, the review supports the growing role of individualized and alternative pharmacologic approaches in the effective management of GERD."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • GAST

Current Status and Future Perspectives of Tegoprazan-Based Helicobacter pylori Eradication Therapy (PubMed, Korean J Helicobacter Up Gastrointest Res) - No abstract available

Journal • Infectious Disease

Comprehensive Analysis of Factors Associated With Helicobacter pylori Eradication Therapy (PubMed, Korean J Helicobacter Up Gastrointest Res) - "In the full-analysis set, the eradication rates according to the regimen were as follows: 7-day tegoprazan-based triple, 61.6%; 14-day tegoprazan-based triple, 77.5%; 14-day rabeprazole-based triple, 71.1%; 10-day rabeprazole-based concomitant, 73.1%; 10-day tegoprazan-based concomitant, 80.5%. The 14-day triple and 10-day concomitant therapy was superior to the 7-day triple therapy regardless of PPI or P-CAB use. However, clarithromycin-resistance mutation status was a more powerful predictor for HP eradication than the type of antibiotics and treatment duration."

Journal • Infectious Disease

Comparison of Tegoprazan- and Lansoprazole-Based Fourteen-Day Triple Therapies as First-Line Treatments for Helicobacter pylori Eradication. (PubMed, Korean J Helicobacter Up Gastrointest Res) - "No significant differences were observed between the two groups with regards to treatment adherence rates (84.4% vs. 85.1%, p=0.78). As a first-line treatment for H. pylori eradication, 14-day tegoprazan-based TT demonstrated non-inferior efficacy compared with 14-day lansoprazole-based TT."

Journal • Infectious Disease

Eradication Therapy for Helicobacter pylori Infection in Patients with Penicillin Allergy or Resistance: A Real-World Study Based on Domestic P-CAB Tegoprazan Dual Therapy (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: the Affiliated Hospital of Putian University; the Affiliated Hospital of Putian University

New P4 trial • Real-world evidence • Allergy • Immunology • Infectious Disease

Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study. (PubMed, Gut Liver) - P3 | "Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917)."

Clinical • Journal • Infectious Disease

Comparative Efficacy and Safety of Tegoprazan Versus Proton Pump Inhibitors for Erosive Esophagitis: A Systematic Review and Meta-Analysis. (PubMed, Cureus) - "However, limitations include the small number of studies, predominantly Asian populations, and relatively short follow-up periods. Further research is needed to assess long-term outcomes and efficacy in diverse populations."

Journal • Retrospective data • Review • Gastrointestinal Disorder • CYP2C19

TALENT: Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment (clinicaltrials.gov) - P=N/A | N=162 | Recruiting | Sponsor: Mario Steffanus | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Peptic Ulcer

Tegoprazan: a novel, highly selective, and potent potassium-competitive acid blocker (P-CAB). (PubMed, Eur J Clin Pharmacol) - "Tegoprazan is a novel PCAB having well-documented tolerance and safety profile thus can be administered for gastric acid diseases. However, current research on Tegoprazan is limited and primarily focuses on Asian regions. This is insufficient; we hope future studies will shed more light on other ethnic groups."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Pain • CYP2C19 • GAST

Advances in Gastroesophageal Reflux Disease Management: Exploring the Role of Potassium-Competitive Acid Blockers and Novel Therapies. (PubMed, Pharmaceuticals (Basel)) - "Emerging treatment options include potassium-competitive acid blockers (PCABs) like vonoprazan, which offer more potent and sustained inhibition of gastric acid secretion compared to traditional PPIs. Additionally, prokinetic agents such as itopride have gained attention due to their potential to improve GERD symptoms by enhancing gastrointestinal motility and accelerating gastric emptying. This article reviews the mechanisms of action, clinical efficacy, and potential of these novel therapeutic approaches in improving patient outcomes in GERD management. With the growing prevalence of PPI resistance and side effects, a personalized, multifaceted approach to treatment is becoming increasingly necessary to optimize care for patients with GERD."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Pain

TOP-GERD: CLINICAL TRIAL FOR THE COMPARATIVE EVALUATION OF ACID SUPPRESSION AND SYMPTOM MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE WITH THE ADMINISTRATION OF TEGOPRAZAN OR PANTOPRAZOLE (clinicaltrials.gov) - P4 | N=128 | Recruiting | Sponsor: Carnot Laboratories

New P4 trial • Gastroenterology • Gastroesophageal Reflux Disease

Accuracy of the diagnosis of gastroesophageal reflux disease by a trial of potassium-competitive acid blocker treatment. (PubMed, BMC Gastroenterol) - P4 | "The P-CAB test (tegoprazan) presents a promising tool for the diagnosis of GERD. A one-week treatment with a criterion of 75% reduction in symptom scores from baseline may be the most cost-effective approach."

Journal • Gastroenterology • Gastroesophageal Reflux Disease

Restoration of intestinal barrier function by fexuprazan, a potassium-competitive acid blocker, in Caco-2 cells and its higher gastrointestinal distribution in rats. (PubMed, Biomed Pharmacother) - "Treatment with fexuprazan, esomeprazole, tegoprazan, and vonoprazan significantly increased TEER values in a 3 % DSS-induced ulcerative colitis Caco-2 cells in a concentration-dependent manner. Fexuprazan showed a particularly high distribution in the liver and gastrointestinal tract in rats following oral administration of 2 mg/kg fexuprazan, which appears to be a positive characteristic of fexuprazan's effect on ulcerative colitis and gastric acid-related diseases although in vivo therapeutic efficacy of fexuprazan for ulcerative colitis requires further validation in both animal and human. In conclusion, fexuprazan can potentially restore intestinal barrier function by increasing the expression of tight junction genes and by strengthening the cell membrane integrity in DSS-induced colitis model."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CLDN1 • MUC1 • OCLN • TJP1

Tegoprazan-Based Dual Therapy With Amoxicillin vs Tetracycline for H. Pylori Eradication (clinicaltrials.gov) - P=N/A | N=87 | Not yet recruiting | Sponsor: Zhongshan Hospital (Xiamen), Fudan University

New trial • Infectious Disease

Mass balance and metabolite profiles in humans of tegoprazan, a novel potassium-competitive acid blocker, using 14C-radiolabelled techniques. (PubMed, Expert Opin Drug Metab Toxicol) - P1 | "Tegoprazan and M1 were the primary compounds present in the circulation. www.clinicaltrials.gov identifier is NCT05883306."

Journal

FROM DAY ONE: TEGOPRAZAN PROVIDES SUPERIOR SYMPTOM RELIEF AND QUALITY OF LIFE IMPROVEMENT IN MEXICAN GERD PATIENTS. AN INTERIM ANALYSIS OF THE TOP-GERD STUDY (DDW 2025) - "Aim: To evaluate the efficacy of TEGO 50 mg daily compared to Pantoprazole (PAN) 40 mg daily over 4 weeks in terms of symptom control, quality of life, and healing in Mexican patients with GERD. TEGO showed significantly faster and more effective symptom relief compared to PAN, with a higher proportion of patients achieving symptom-free status as early as the first week of treatment in Mexican GERD patients. These early improvements, combined with superior quality of life scores and endoscopic healing, position TEGO as a highly effective treatment option for GERD in a Hispanic population."

Clinical • HEOR • Gastroesophageal Reflux Disease

COMPARATIVE EFFICACY OF POTASSIUM-COMPETITIVE ACID BLOCKERS VERSUS PROTON PUMP INHIBITORS IN EROSIVE ESOPHAGITIS: A META-ANALYSIS BASED ON THE LOS ANGELES CLASSIFICATION (DDW 2025) - "In these four included studies, P-CAB agents used were vonoprazan and tegoprazan while lansoprazole was the PPI agent used. This efficacy was more prominent in patients with EE LA grade C/D (OR 2.526 [95% CI 1.462 – 4.363], p = 0.001) than in LA grade A/B (OR 1.442 [95% CI 1.028 – 2.023], p = 0.034) (Figure 1). Conclusion P-CAB-treated patients exhibited a better remission rate of EE compared to PPIs-treated patients at 24 weeks."

Retrospective data • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

SHORT-TERM EFFICACY OF TEGOPRAZAN COMPARED WITH ESOMEPRAZOLE IN PATIENTS WITH NON-EROSIVE REFLUX DISEASE WITH NOCTURNAL HEARTBURN SYMPTOM: A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL (DDW 2025) - "Tegoprazan was effective in symptomatic relief in NERD patients with nocturnal heartburn symptoms."

Clinical • Gastroenterology • Gastroesophageal Reflux Disease

NORMAL VALUES FOR AMBULATORY 24-HOUR PH-IMPEDANCE MONITORING "ON" POTASSIUM-COMPETITIVE ACID BLOCKERS (PCABS). (DDW 2025) - "AIM To assess the impact of a standard daily dose of tegoprazan (TEGO) and fexuprazan (FEXU) over one week on 24-hour reflux parameters measured through pH-imp, and to establish normal reference values for 'on-therapy' PCAB treatment. Both TEGO and FEXU significantly reduced acid reflux episodes and the percentage of time with esophageal pH 4. These findings highlight the potential of pH-imp as a diagnostic tool for refractory GERD under PCAB therapy."

Gastroesophageal Reflux Disease

EFFICACY AND SAFETY OF HIGH-DOSE DUAL THERAPY WITH POTASSIUM-COMPETITIVE ACID BLOCKERS AND AMOXICILLIN FOR HELICOBATER PYLORI READICATION: A REAL-WORLD, RETROSPECTIVE, MULTICENTER CLINICAL STUDY (DDW 2025) - "The bismuth quadruple therapy group (BQT, n=512) received esomeprazole (20 mg, twice daily), potassium bismuth citrate (240 mg, twice daily), amoxicillin (1 g, twice daily), and clarithromycin (500 mg, twice daily). High-dose PA dual therapy demonstrates superior efficacy and a lower incidence of AEs in the treatment of H. pylori infection, making it particularly suitable for previously treated patients and middle-aged or older individuals."

Real-world • Real-world evidence • Retrospective data • Infectious Disease

EFFICACY AND SAFETY OF HIGH-DOSE DUAL THERAPY WITH POTASSIUM-COMPETITIVE ACID BLOCKERS AND AMOXICILLIN FOR HELICOBACTER PYLORI ERADICATION IN ELDERLY PATIENTS: A REAL-WORLD, RETROSPECTIVE, MULTICENTER CLINICAL STUDY (DDW 2025) - "Bismuth quadruple therapy (BQT, n=53): esomeprazole 20 mg twice daily, potassium bismuth citrate 240 mg twice daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily for 14 days. A total of 161 elderly patients were enrolled, comprising 96 males and 65 females. In the intention-to-treat analysis, the eradication rate was significantly higher in the PA group at 94.44% (102/108) compared to 77.36% (41/53) in the BQT group, with a statistical significance of P=0.027 (Figure 1a). In PA treatment, the eradication rate of vonoprazan-amoxicillin (VA) was 95.95% (71/74), which showed no significant difference compared to the tegoprazan-amoxicillin (TA) at 89.29% (30/34) (P=0.421) (Figure 1d)."

Real-world • Real-world evidence • Retrospective data • Gastric Cancer • Infectious Disease • Oncology • Solid Tumor

THE EFFECT OF TEGOPRAZAN FOR PREVENTION OF IATROGENIC ULCER BLEEDING AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION: A MULTICENTER, RANDOMIZED, OPEN, ACTIVE-CONTROLLED STUDY (DDW 2025) - "Of the 288 patients, 238 patients were included in the per protocol set (tegoprazan: N=117, pantoprazole: N=121). Baseline characteristics were comparable between groups. Overall bleeding rates within 4 weeks were 9.4% (11/117) and 15.7% (19/121) for tegoprazan and pantoprazole group, respectively (-6.3[-14.7, 2.1]; non-inferiority margin of 8.3%)."

Clinical • Gastric Cancer • Oncology • GAST

Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: Soonchunhyang University Hospital | Recruiting ➔ Completed

Trial completion • Infectious Disease