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

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

Tegoprazan and Amoxicillin Dual Therapy (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Soonchunhyang University Hospital

New trial • Infectious Disease

Tegoprazan- Versus PPI-based H. Pylori Eradication (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Soonchunhyang University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Structure Determination of Tegoprazan((S)-4-((5,7-difluorochroman-4-yl)oxy)-N,N,2-trimethyl-1H-benzo[d]imidazole-6-formamide) Polymorphs A and B by Laboratory X-Ray Powder Diffraction. (PubMed, Molecules) - "Instead, single-point energy calculations were performed on the refined models. The resulting relative energy differences, together with solubility data, van't Hoff enthalpies, and DSC profiles, consistently indicated that Polymorph A is more stable than Polymorph B. These results highlight the challenges of structure validation via DFT-D for complex molecular crystals and demonstrate the value of integrating experimental and computational approaches for polymorph characterization."

Journal • CDKN1A

Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial. (PubMed, Helicobacter) - P=N/A | "The 7- and 14-day TTQT efficacies for the first-line treatment of H. pylori infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433)."

Clinical • Head-to-Head • Journal • Infectious Disease

Efficacy and Safety of Cefuroxime-Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial. (PubMed, Helicobacter) - P4 | "BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of H. pylori in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens."

Clinical • Journal • Allergy • Immunology • Infectious Disease

Potassium-competitive acid blocker versus proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial. (PubMed, Am Heart J) - P4 | "PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding."

Clinical • Journal • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Peptic Ulcer • CYP2C19

K-Cap Generic Approval… Kyungdong Pharmaceutical's 'tegoprazan' Product Approval Obtained [Google translation] (HIT News, HIT News) - "The Ministry of Food and Drug Safety approved Kyungdong Pharmaceutical's 'Tegozan 50mg', the first generic containing the ingredient tegoprazan, on the 1st..However, the release date is unclear due to patent litigation. HK inno.N won the second trial regarding the K-Cap compound (substance) patent in February....There are two types of K-Cap patents: a ‘material patent’ that lasts until 2031 and a ‘crystal patent’ that lasts until 2036. The K-Cap crystal patent lawsuit, which lasts until March 12, 2036, is currently in the second trial after HK inno.N lost the first trial...On the other hand, HK inno.N is in an advantageous position in the case of material patents. The original term of the K-Cap material patent was until December 6, 2026, but the term was extended to August 25, 2031 in recognition of the time required for pharmaceutical research and development and approval."

Korea approval • Patent • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

K-Cap Generic Approval… Kyungdong Pharmaceutical's 'tegoprazan' Product Approval Obtained [Google translation] (HIT News, HIT News) - "The Ministry of Food and Drug Safety approved Kyungdong Pharmaceutical's 'Tegozan 50mg', the first generic containing the ingredient tegoprazan, on the 1st..However, the release date is unclear due to patent litigation. HK inno.N won the second trial regarding the K-Cap compound (substance) patent in February....There are two types of K-Cap patents: a ‘material patent’ that lasts until 2031 and a ‘crystal patent’ that lasts until 2036. The K-Cap crystal patent lawsuit, which lasts until March 12, 2036, is currently in the second trial after HK inno.N lost the first trial...On the other hand, HK inno.N is in an advantageous position in the case of material patents. The original term of the K-Cap material patent was until December 6, 2026, but the term was extended to August 25, 2031 in recognition of the time required for pharmaceutical research and development and approval."

Korea approval • Patent • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A clinical study on the treatment of Helicobacter pylori infection with a combination therapy of tegoprazan and amoxicillin (ChiCTR) - P=N/A | N=284 | Not yet recruiting | Sponsor: Fujian Provincial Hospital; Fujian Provincial Hospital

New trial • Infectious Disease

Efficacy of Potassium Competitive Acid Blockers (PCABs) vs Proton Pump Inhibitors (PPIs) for Healing of Duodenal Ulcers: A Systematic Review and Meta Analysis (APASL 2025) - "PCABs such as Vonoprazan, Tegoprazan, Soraprazan, Revaprazan, Keverprazan and Linaprazan are reversible, competitive antagonists of the H+/K+ ATPase that is seen to have more sustained acid suppression. PCABs such as Vonoprazan 20mg and Keverprazan 20mg are non inferior to PPIs in the healing of duodenal ulcers. Both classes of drugs had similar tolerability profiles. Table and Figure:Figure 1.Forest plot of PCAB vs PPI on healing of duodenal ulcers at Week 6 Figure 2.Forest plot of PCAB vs PPI on healing of duodenal ulcers at Week 4"

Retrospective data • Review • Chronic Kidney Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Peptic Ulcer • Renal Disease

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

New trial • Gastroenterology • Peptic Ulcer

Effect of tegoprazan on temporal variability of platelet reactivity in patients treated with clopidogrel after coronary stenting. (PubMed, Korean J Intern Med) - "The prevalence of high on-treatment platelet reactivity, defined as ≥ 253 PRU, was also similar between the groups at 3 (10.3% vs. 10.2%, p = 0.976), 6 (7.0% vs. 8.2%, p = 1.000), and 12 months (4.3% vs. 9.0%, p = 0.503). There was no significant difference in platelet reactivity between the tegoprazan and PPI groups in patients undergoing PCI and receiving dual antiplatelet therapy with clopidogrel."

Journal

Efficacy of Potassium-Competitive Acid Blockers Versus Proton Pump Inhibitors for Gastric Ulcers: Bayesian and Frequentist Network Meta-Analysis With Cross-Inference Through a Quality management System. (PubMed, Curr Ther Res Clin Exp) - "The odds ratios (ORs) for the 4-week cure rate in Bayesian + frequentist NMA, tegoprazan 100 mg (OR = 4.14, 95% credible interval [CI] 0.56-26.3) and pantoprazole 40 mg (OR = 4.12, 95% CI 1.90-8.88) were the largest, respectively. The ORs for the 8-week cure rate in Bayesian + frequentist NMA, lansoprazole 30 mg (OR = 8.77, 95% credible interval [CI] 0.95-78.9) and lansoprazole 30 mg (OR = 7.91, 95% CI 2.60-24.03) was the largest, respectively. The results of the NMA reveal that the cure rates of P-CABs in cases of GU were not inferior to those of PPIs. As the inference by grouping PPIs and P-CABs, the results showed similar trends in terms of effectiveness between the two therapeutic classes."

Journal • Retrospective data • Peptic Ulcer

Tegoprazan-Containing Versus Proton Pump Inhibitor-Containing Therapy for First-Line Eradication of Helicobacter pylori: A Meta-Analysis of Randomized Controlled Trials. (PubMed, JGH Open) - "Tegoprazan-containing therapy demonstrated comparable treatment-emergent adverse event (TEAE) rates compared to PPI-containing therapy (46.48% vs. 46.31%; RR 1.026; 95% CI 0.952-1.106; I 2 = 48%). This meta-analysis demonstrated that Tegoprazan-containing therapy is superior to PPI-containing therapy for first-line H pylori eradication, with comparable safety profiles."

Journal • Retrospective data • Review • Infectious Disease

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) - No abstract available

Clinical • HEOR • Gastroesophageal Reflux Disease

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) - No abstract available

Clinical • Gastroenterology • Gastroesophageal Reflux Disease

THE EFFECT OF TEGOPRAZAN FOR PREVENTION OF IATROGENIC ULCER BLEEDING AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION: A MULTICENTER, RANDOMIZED, OPEN, ACTIVE-CONTROLLED STUDY (DDW 2025) - No abstract available

Clinical

PPIs Have It: Does Tegoprazan Affect Gastric Emptying and Produce Dyspeptic Symptoms? (PubMed, Dig Dis Sci) - "This commentary contextualizes these results within the broader landscape of functional dyspepsia management, highlighting the potential benefits of tegoprazan in patients requiring antisecretory therapy, emphasizing the need for further research into its long-term impacts on motility, gut microbiota composition, and symptomatology. This analysis underscores how P-CABs may redefine antisecretory therapies."

Journal • Dyspepsia

So Many Choices, So Little Value: Potential Savings from Selecting Cost-Effective Proton Pump Inhibitors. (PubMed, Pharmacoecon Open) - "This study identified opportunities for substantial cost savings related to PPI prescribing. Guided decision-making toward cost-effective PPI prescribing would increase the efficiency of prescribing and the sustainability of the healthcare system."

HEOR • Journal

Phase I Study to Evaluate the Effect of Hepatic Impairment on Pharmacokinetics and Safety of Tegoprazan, a Potassium Competitive Acid Blocker. (PubMed, Adv Ther) - P1 | "Systemic exposure to tegoprazan tended to be increased in subjects with HI. The difference between patients with mild HI and the controls was deemed not to require dose adjustment for tegoprazan."

Journal • P1 data • PK/PD data • Hepatology

The efficacy and safety of Vonoprazan and Tegoprazan in Helicobacter pylori eradication: a comprehensive systematic review and meta-analysis of randomized controlled trials. (PubMed, Therap Adv Gastroenterol) - "This enhanced efficacy was particularly pronounced in patients with clarithromycin-resistant infections (73.7% vs 41.5%, RR = 1.53, 95% CI: 1.07-2.20, p = 0.02). P-CAB-based therapies are more effective than traditional PPI-based treatments for eradicating H. pylori infection, with a reduced incidence of adverse events. CRD42024503665."

Journal • Retrospective data • Infectious Disease

Comparison of tegoprazan and proton pump inhibitors for first-line Helicobacter pylori eradication: a systematic review with meta-analysis. (PubMed, Expert Rev Anti Infect Ther) - "H. pylori eradication and adverse drug event rates with TPZ- and PPI-based treatments were similar."

Journal • Retrospective data • Review • Infectious Disease

Tegoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori -Non-inferiority, Multicenter, Randomized controlled study (ChiCTR) - P=N/A | N=228 | Recruiting | Sponsor: The Second Affiliated Hospital of Chongqing Medical University; The Second Affiliated Hospital of Chongqing Medical University

New trial • Infectious Disease

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Erosive Esophagitis (clinicaltrials.gov) - P3 | N=1250 | Active, not recruiting | Sponsor: Braintree Laboratories | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Jun 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Disorder