K-CAB Tab (tegoprazan)
/ Luoxin Pharma, RaQualia, Korea Kolmar, Sebela
- LARVOL DELTA
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December 12, 2025
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
December 12, 2025
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
December 12, 2025
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
December 11, 2025
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
November 22, 2025
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
November 22, 2025
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
November 17, 2025
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
November 11, 2025
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
November 13, 2025
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
October 18, 2025
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
November 10, 2025
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
August 30, 2025
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
August 30, 2025
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
August 30, 2025
Seven-Day Tegoprazan Therapy Matches Proton Pump Inhibitors and 14-Day Therapies for H. pylor Eradication With Much Fewer Adverse Events: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
(ACG 2025)
- "Introduction: Despite guideline-mandated 14-day quadruple therapy, real-world eradication of Helicobacter pylori continues to falter because proton-pump inhibitors (PPIs) give slow, CYP2C19-dependent acid control and carry growing clarithromycin resistance. Four RCTs (N = 1,668; 7-day Tegoprazan = 841, control = 827) showed identical eradication efficacy confirmed by urea breath test (RR 0.99, 95% CI 0.94-1.04; I² = 0%) with the abbreviated Tegoprazan regimen. Serious adverse events (SAEs) fell by 40% (RR 0.60, 95% CI 0.41-0.89; I² = 0%), translating to 1 fewer SAE per ~ 43 patients treated. Overall adverse-event rates were numerically lower (RR 0.83, 95% CI 0.63-1.11) but heterogeneous (I² = 82%), while treatment discontinuation remained comparable (RR 0.95, 95% CI 0.62-1.44; I² = 0%). Rapid, potent acid suppression allows a 7-day Tegoprazan backbone to deliver guideline-level cure rates while halving serious toxicity versus PPI or longer PCAB..."
Adverse events • Retrospective data • Review • Dyspepsia • Infectious Disease • CYP2C19
August 30, 2025
Four-Week Healing Rates of Erosive Esophagitis: A Network Meta-Analysis of P-CABs versus PPIs
(ACG 2025)
- "Twelve trials involving 4,263 patients evaluated 4-week healing rates in erosive esophagitis. Treatments included vonoprazan (32.8%), tegoprazan (9.1%), fexuprazan (5.9%), keverprazan (2.5%), zastaprazan (3.1%), linaprazan (4.2%), and PPIs (42.5%). Most patients (73.2%) had LA grade A or B esophagitis, while 26.8% had grade C or D. Only zastaprazan 20 mg demonstrated a statistically significant improvement in the overall healing rate compared to PPIs (OR: 2.75, 95% CI: 1.06 to 7.13)."
Retrospective data • Gastrointestinal Disorder
August 30, 2025
Comparative Efficacy and Safety of Tegoprazan vs Proton Pump Inhibitors for Erosive Esophagitis: A Meta-Analysis of Randomized Controlled Trials
(ACG 2025)
- "Four RCTs encompassing a total of 812 patients were included in the analysis. Tegoprazan demonstrated similar healing rates to PPIs at both 4 weeks (RR 1.05, 95% CI: 0.99–1.11; p=0.12) and 8 weeks (RR 1.02, 95% CI: 0.98–1.06; p=0.35). Subgroup analyses by dose (50 mg and 100 mg) showed no significant differences."
Retrospective data • Gastrointestinal Disorder
August 30, 2025
Mapping a Global Decade of Potassium-Competitive Acid Blockers Use: Geographic and Temporal Disparities in Scientific Productions
(ACG 2025)
- "Introduction: Potassium-competitive acid blockers (P-CABs), including vonoprazan, tegoprazan, and fexuprazan, have emerged as potent alternatives to proton pump inhibitors for acid-related disorders, particularly GERD and H. pylori eradication. A total of 670 P-CAB–related documents were published across 206 sources, with an annual growth rate of 13.53%. Research output rose steeply after 2014, correlating with the introduction of vonoprazan. Japan led all countries with 242 publications, followed by China (158), South Korea (100), and the USA (54)."
Clinical • Gastroesophageal Reflux Disease
August 30, 2025
Efficacy of Vonoprazan versus Lansoprazole in Erosive Esophagitis: A Systematic Review and Meta-Analysis
(ACG 2025)
- "Six randomized controlled trials with a total of 3,655 patients were included. Both vonoprazan 10 mg and 20 mg significantly reduced the risk of EE recurrence at 24 weeks compared to lansoprazole, with odds ratios of 0.44 and 0.33 (p = .001 and p = .002, respectively), and the effect was more pronounced with the 20 mg dose. In the induction phase, both doses of vonoprazan were also associated with significantly higher healing rates than lansoprazole (OR 1.51 and 1.87; p = .001 and p < .001, respectively), with greater benefit observed at 20 mg."
Retrospective data • Review • Gastrointestinal Disorder
October 29, 2025
Tegoprazan-Amoxicillin Dual Therapy for Clarithromycin-Resistant Helicobacter pylori: A Feasibility Pilot Study.
(PubMed, Microorganisms)
- "In conclusion, the eradication efficacy of TA dual therapy against clarithromycin-resistant H. pylori strain infections was suboptimal in treatment-naïve patients. Notably, eradication rates were significantly lower in patients with a prior history of H. pylori treatment."
Journal • Infectious Disease
July 09, 2025
ALTERATIONS IN GUT MICROBIOTA AND SYMPTOMS FOLLOWING HELICOBACTER PYLORI ERADICATION THERAPY IN PATIENTS WITH FUNCTIONAL DYSPEPSIA, WITH OR WITHOUT HELICOBACTER PYLORI INFECTION
(UEGW 2025)
- "All patients were treated with tegoprazan 50 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, twice daily for 10 days, regardless of Hp status. Hp eradication therapy resulted in gut microbiota alterations and symptom improvement, regardless of H. pylori status. Duodenal microbial diversity tended to decrease after treatment, and this pattern was observed in both Hp(+) and Hp(–) groups, although the magnitude of change differed. These microbiota shifts may have contributed to the observed improvement in symptoms."
Clinical • Gut Microbiota • Dyspepsia • Infectious Disease
July 09, 2025
PRESCRIPTION OF FIRST-LINE EMPIRICAL TREATMENTS FOR HELICOBACTER PYLORI INFECTION OUTSIDE EUROPE: RESULTS OF 10,000 CASES FROM THE WORLD-WIDE REGISTRY ON H. PYLORI MANAGEMENT (WORLDHPREG)
(UEGW 2025)
- "Most treatments lasted 14 days (86%), with PPIs prescribed at either low-dose (20 mg omeprazole equivalent b.i.d.) in 42% of cases or high-dose (80 mg omeprazole equivalent b.i.d.) in 36% of cases. Vonoprazan, tegoprazan and fexuprazan were prescribed in 5%, 2% and 1.3% of cases.Table 1. Most frequent first-line empirical treatments worldwide.CountryLATAMBrazilAfricaASEANAustraliaCanadaEgyptIndiaJordanPakistanSaudi ArabiaTreatment(a)N..."
Clinical • Dyspepsia • Gastroenterology • Infectious Disease
July 09, 2025
EVALUATION OF POTASSIUM-COMPETITIVE ACID BLOCKERS VERSUS PROTON PUMP INHIBITORS IN EROSIVE ESOPHAGITIS: A NETWORK META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS [WITHDRAWN]
(UEGW 2025)
- "The P-CABs included in these studies were vonoprazan, keverprazan, zastaprazan, tegoprazan, and fexuprazan, while the PPIs used were lansoprazole 30 mg and esomeprazole 40 mg. Most P-CABs demonstrated similar efficacy to PPIs. However, vonoprazan, particularly at a dose of 20 mg, showed superior healing and endoscopic remission compared to PPIs in patients with erosive esophagitis. However, larger trials are needed to confirm this superiority."
Retrospective data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Solid Tumor
July 09, 2025
A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TEGOPRAZAN-BASED STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION
(UEGW 2025)
- "Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC1), tegoprazan 100 mg (TAC2), or lansoprazole 30 mg (LAC) with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 14 days. Tegoprazan-based STT demonstrated non-inferiority to lansoprazole-based STT, achieving eradication rates above 80% in the FAS population. Given its efficacy and safety profile, tegoprazan-based triple therapy may serve as an effective first-line treatment option for H. pylori eradication."
Clinical • Infectious Disease
July 09, 2025
NON-INFERIORITY TRIAL OF TEGOPRAZAN VERSUS ESOMEPRAZOLE FOR ERADICATING HELICOBACTER PYLORI INFECTION IN TREATMENT-NAIVE LATIN PATIENTS
(UEGW 2025)
- P4 | "Patients were randomized to receive either Tego (50 mg) or Eso (40 mg), both in combination with Amoxicillin (1 g) and Clarithromycin (500 mg), all administered twice daily for 14 days. Our work shows that Tegoprazan is equally effective and safe as Esomeprazole for triple therapy to eradicate Helicobacter pylori in Latin population. We also found that eradication treatment improves general health, physical functioning, and physical component summary, which warrants further investigation. Clinical Trials registration: NCT06318104."
Clinical • Head-to-Head • Infectious Disease
July 09, 2025
NEAR-COMPLETE ERADICATION OF HELICOBACTER PYLORI IN A LATIN AMERICAN COHORT USING LIMECYCLINE–TEGOPRAZAN-BASED QUADRUPLE THERAPY: BREAKING RESISTANCE IN THE REAL WORLD
(UEGW 2025)
- "pylori), especially in Latin America, where resistance to clarithromycin and metronidazole exceeds 20–30%. This multicentre pilot study demonstrates that the limecycline–furazolidone–bismuth–tegoprazan quadruple regimen is a highly effective and well-tolerated option for H. pylori eradication in Latin American real-world settings. A near-100% eradication rate (98.6%; 95% CI: 92.6–99.9%), including in patients with treatment failure, supports its use as both empirical first-line and salvage therapy. Limecycline emerges as a promising substitute for tetracycline, and tegoprazan offers robust acid control."
Clinical • Real-world • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Infectious Disease
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