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

The promise and pitfalls of emerging potassium-competitive acid blockers for the treatment of gastroesophageal reflux disease. (PubMed, Expert Opin Pharmacother) - No abstract available

Journal • Gastroenterology • Gastroesophageal Reflux Disease

Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter pylori Eradication: An Inverse Probability of Treatment-Weighted Multicenter Study. (PubMed, J Infect Dis) - "HDDT, particularly VA-14, is a competitive first-line option for H. pylori eradication. High BSA and low adherence were risk factors for eradication failure but varied across regimens, highlighting the necessity of personalized adjustment."

Clinical • Journal • Infectious Disease

Efficacy and Safety of Tegoprazan in Continuous Maintenance versus On-Demand Therapy for Patients with Non-Erosive Reflux Disease and Mild Esophagitis: A Prospective, Multicenter, Randomized, Controlled Clinical Study (ChiCTR) - P=N/A | N=128 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University; The First Affiliated Hospital with Nanjing Medical University

New trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Clinical Outcomes of Tegoprazan Versus Proton Pump Inhibitors in Patients Receiving Antiplatelet Therapy After Percutaneous Coronary Intervention: A Retrospective, Observational Study. (PubMed, Korean J Helicobacter Up Gastrointest Res) - "Tegoprazan was associated with similar rates of nonfatal MI (0.8% vs. 2.4%; p=0.125) and death from CV-related causes (0.4% vs. 0%; p=0.258) as PPIs. There were no significant differences in GI- or CV-related complications between patients treated with tegoprazan and those treated with PPIs."

Clinical data • Journal • Observational data • Retrospective data • Cardiovascular • Coronary Artery Disease • Gastroenterology • Heart Failure • Myocardial Infarction • Peptic Ulcer

Pharmacokinetics of the potassium-competitive acid blocker tegoprazan administered by the oral route in healthy Mexicans. (PubMed, Int J Clin Pharmacol Ther) - "Since no clinically relevant pharmacokinetic differences were observed in the pharmacokinetics of tegoprazan, a substrate for CYP3A4, between Mexicans and Koreans, it is concluded that the efficacy and safety data for tegoprazan obtained in Koreans will be valid in the Mexican population."

Journal • PK/PD data • Gastrointestinal Disorder • CYP3A4

Acid-suppressive effect of tegoprazan 12.5 mg BID: a phase 1 comparative study with tegoprazan 25 mg QD and famotidine 20 mg BID. (PubMed, Transl Clin Pharmacol) - "Tegoprazan 12.5 mg BID was well tolerated, with no adverse events reported in this group. These findings suggest that low-dose tegoprazan 12.5 mg BID provides safe and sustained acid suppression."

Journal • P1 data

Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1) (clinicaltrials.gov) - P4 | N=370 | Completed | Sponsor: Zhang Xiaofeng,MD | Active, not recruiting ➔ Completed | N=100 ➔ 370 | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Enrollment change • Head-to-Head • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

A Mechanism-Based Multi-Level Population PK/PD Model for Potassium-Competitive Acid Blockers. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "A multi-leveled population analysis was conducted using published pharmacokinetic and pharmacodynamic data on four representative PCABs: tegoprazan, YH4808, fexuprazan, and vonoprazan. The findings support drug-specific dose optimization and highlight the clinical relevance of food-drug interactions. The modeling approach provides a model platform for pharmacotherapy or model-informed drug development (MIDD)."

Journal • PK/PD data

Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical Trial. (PubMed, Helicobacter) - P2 | "Tegoprazan-based triple therapies, at 50- and 100-mg doses, were non-inferior to lansoprazole-based therapy and were well tolerated. Our findings indicated that tegoprazan-based triple therapy is a viable first-line option for H. pylori eradication."

Clinical • Journal • P3 data • Infectious Disease

Risk of Depression Related to Use of Proton Pump Inhibitors and Tegoprazan: A Nationwide Cohort Study. (PubMed, J Korean Med Sci) - "In this national longitudinal study, PCAB users had a lower likelihood of developing depression than PPI users. Additional studies on the biological mechanism for the risk of depression and gastric acid suppressants are needed."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

A systematic review and meta-analysis of randomized controlled trials: the effect of potassium-competitive acid blockers on nighttime symptoms of gastroesophageal reflux disease. (PubMed, Esophagus) - "We included randomized controlled trials (RCTs) that compared any PCAB (vonoprazan, tegoprazan, or fexuprazan) with either a PPI or placebo in adult GERD patients. The findings were consistent across all sensitivity analyses. Our study results suggest that PCABs therapy may provide better nighttime heartburn resolution than PPIs."

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

Sebela Pharmaceutical Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux Disease (PRNewswire) - "The NDA seeks simultaneous approval for three indications: treatment of heartburn associated with non-erosive reflux disease (NERD), healing of erosive esophagitis (EE), and maintenance of EE healing....The NDA submission is supported by robust data from the pivotal Phase 3 TRIUMpH clinical program, which enrolled over 2,000 US patients and demonstrated tegoprazan's clinical superiority over a PPI across multiple endpoints."

FDA filing • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

The Efficacy of Potassium-Competitive Acid Blocker Compared With Double Dose of Proton Pump Inhibitor in Patients With Refractory Gastro-Esophageal Reflux Disease: A Case-Control Study. (PubMed, Korean J Helicobacter Up Gastrointest Res) - "Double split doses of rabeprazole (20 mg) or tegoprazan (50 mg) were prescribed for 2 weeks, and the symptoms were subsequently evaluated. In patients with refractory GERD symptoms, PCAB therapy had effects corresponding to those of a double split dose of PPIs. PCAB therapy was therefore deemed superior to PPIs, especially in patients with abnormal AETs."

Journal • Gastroenterology • Gastroesophageal Reflux Disease

Evaluation of the Safety and Efficacy of K-CAB (Tegoprazan) as Symptomatic Maintenance Therapy in Patients With NERD: A Multicenter, Randomized Double-Blinded Controlled Trial. (PubMed, Korean J Helicobacter Up Gastrointest Res) - "Both treatments were well tolerated, with no serious adverse events reported. These findings suggest that alternate-day tegoprazan offers comparable efficacy and safety to daily lansoprazole therapy and may serve as a more flexible and patient-friendly maintenance option for NERD."

Clinical • Journal • Gastroenterology • Gastroesophageal Reflux Disease

A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=74 | Not yet recruiting | Sponsor: HK inno.N Corporation

New P1 trial

Fourteen-and Ten-Day Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for Helicobacter pylori Eradication-A Noninferiority, Multicenter, Randomized Controlled Trial. (PubMed, J Gastroenterol Hepatol) - "The eradication rate of the 14-THA group is > 90%, which is not inferior to the current bismuth-containing quadruple regimen, with a favorable safety profile. However, the efficacy of the 10-THA dual therapy is unacceptable."

Head-to-Head • Journal • Infectious Disease

FAST-HP: Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori） (clinicaltrials.gov) - P4 | N=240 | Not yet recruiting | Sponsor: First People's Hospital of Hangzhou

New P4 trial • Infectious Disease

TV-HP: Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication (clinicaltrials.gov) - P2/3 | N=240 | Recruiting | Sponsor: First People's Hospital of Hangzhou

Head-to-Head • New P2/3 trial • Infectious Disease

Comparison of tegoprazan-based high-dose dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicentre, randomised controlled trial in Gansu Province, a high-resistance region of China. (PubMed, Therap Adv Gastroenterol) - P4 | "Participants were randomised 1:1 to receive either BQT (esomeprazole 20 mg twice daily + bismuth potassium citrate 600 mg twice daily + amoxicillin 1000 mg twice daily + metronidazole 400 mg four times daily) or TA (tegoprazan 50 mg twice daily + amoxicillin 750 mg four times daily) for 14 days. The inferior eradication efficacy of TA precludes its recommendation as a first-line therapy in high-resistance settings, such as Gansu. This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081873."

Journal • Infectious Disease

A Novel UPLC-MS/MS Method for Determining Tegoprazan in Rat Plasma: An Application in a Rat Pharmacokinetic Study. (PubMed, Biomed Chromatogr) - "The internal standard revaprazan (REV) and TEG were analyzed separately on a Waters ACQUITY UPLC BEH column. We finally established a rapid and robust UPLC-MS/MS quantitative analysis of TEG in rat plasma. Rat pharmacokinetics indicated that TEG was absorbed quickly and fast reached the maximum concentration."

Journal • PK/PD data • Preclinical • Gastroenterology • Gastroesophageal Reflux Disease

Tegoprazan Versus Proton Pump Inhibitors for Erosive Esophagitis: A Meta-Analysis of Noninferiority Randomized Controlled Trials. (PubMed, JGH Open) - "While healing rates were slightly higher, particularly with the 100 mg dose, the differences were not statistically significant. Tegoprazan may be a suitable alternative for patients intolerant to PPIs, though larger, long-term, multiethnic studies are warranted to confirm these findings and assess patient-centered outcomes."

Head-to-Head • Journal • Retrospective data • Review • Gastrointestinal Disorder • Pain

Potassium-Competitive Acid Blocker Use and Risk of Incident CKD: Korean Nationwide Study (KIDNEY WEEK 2025) - "Conclusion In this real-world study, tegoprazan prescription for > 90 days was associated with a 14% and 9% higher risk of CKD development than H2RAs and PPIs, respectively. Alerts regarding kidney function monitoring are required until new evidence emerges."

Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

Efficacy of Potassium-Competitive Acid Blockers in Functional Dyspepsia: A Systematic Review and Meta-Analysis. (PubMed, Gastroenterology Res) - "Potassium-competitive acid blockers (PCABs), such as vonoprazan and tegoprazan, provide rapid and sustained gastric acid inhibition and may represent a therapeutic alternative. PCABs show promise as a potential therapeutic option in FD, particularly in patients who do not respond to or cannot tolerate proton pump inhibitors. Further placebo-controlled trials are needed to confirm efficacy and define long-term outcomes."

Journal • Retrospective data • Dyspepsia • Gastroenterology • Gastrointestinal Disorder

Efficacy of Potassium Channel Acid Blockers for Non-Erosive Reflux Disease: A Systematic Review and Meta-Analysis (ACG 2025) - "Our analysis included four phase III double-blind randomized trials comparing the efficacy of P-CABs (tegoprazan 50 mg and vonoprazan 10 mg) to placebo in the treatment of NERD. A total of 1760 patients were analyzed, with 880 (50%) patients receiving P-CABS, and 880 (50%) receiving placebo. Table 1 describes the main characteristics of the included studies and their patients."

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

Second Generation Potassium-Competitive Acid Blockers Match Proton Pump Inhibitors in Healing and Safety for Erosive Esophagitis: A Systematic Review and Meta-Analysis of Four Double-Blind, Randomized Controlled Trials (ACG 2025) - "Second-generation potassium-competitive acid blockers (P-CABs)—notably Tegoprazan and Fexuprazan—provide faster, meal-independent and more durable pH elevation than the first-in-class agent Vonoprazan. Four double-blind RCTs comprising 1,085 patients with erosive oesophagitis (PPI = 543; P-CAB = 542) met eligibility. The efficacy endpoint showed Endoscopic healing at 4 weeks was achieved in 83 % of PPI-treated vs 87 % of P-CAB–treated participants (421/505 vs 448/514; RR 0.96, 95 % CI 0.91–1.01; I² = 0 %), and at 8 weeks in 93 % vs 95 % (478/512 vs 490/518; RR 0.99, 95 % CI 0.96–1.02; I² = 0 %). The Safety endpoint showed treatment-emergent adverse events occurred in 31 % of PPI and 28 % of P-CAB recipients (171/543 vs 156/549; RR 1.11, 95 % CI 0.93–1.32; I² = 0 %)."

Retrospective data • Review • Gastrointestinal Disorder