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- K-CAB Tab (tegoprazan) / RaQualia, Sebela
CLINICAL OUTCOMES OF TEGOPRAZAN OR PPI COMBINATION THERAPY IN PATIENTS TAKING ANTIPLATELET AGENTS AFTER PERCUTANEOUS CORONARY INTERVENTION (Hall A, Poster Hall - Walter E. Washington Convention Center) - May 18, 2024 - Abstract #DDW2024DDW_8712;
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela, Takecab (vonoprazan) / Takeda, Phathom Pharma
Retrospective data, Review, Journal: P-CAB versus PPI in the eradication of Helicobacter pylori: a systematic review and network meta-analysis. (Pubmed Central) - May 16, 2024
In the eradication treatment of Hp, the efficacy and safety of vonoprazan-based regimens are generally better than those of PPI-based regimens. Among them, the V-Tri-2w regimen has the highest eradication rate and may be the preferred choice for Hp eradication.
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
P1 data, PK/PD data, Journal: Pharmacokinetic Interactions Between Tegoprazan and the Combination of Clarithromycin, Amoxicillin and Bismuth in Healthy Chinese Subjects: An Open-Label, Single-Center, Multiple-Dosage, Self-Controlled, Phase I Trial. (Pubmed Central) - May 11, 2024
The plasma exposure of tegoprazan, M1, 14-hydroxyclarithromycin and bismuth was increased after the coadministration of tegoprazan, clarithromycin, amoxicillin and bismuth. The coadministration exhibited favorable safety and tolerability.
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Retrospective data, Review, Journal: Efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease: A protocol for meta-analysis and systematic review. (Pubmed Central) - May 2, 2024
The coadministration exhibited favorable safety and tolerability. The results of this study will provide reliable evidence to evaluate the efficacy and safety of tegoprazan in the treatment of GERD and help patients, physicians and clinical investigators choose the most appropriate treatment.
- || Clinical, Retrospective data, Review, Journal: Treatment of Helicobacter pylori with potassium competitive acid blockers: A systematic review and meta-analysis. (Pubmed Central) - Apr 9, 2024
VPZ-based triple therapy outperformed conventional PPI-based triple therapy in eradicating H. pylori, positioning it as a highly effective first-line regimen. Additionally, TPZ-based triple therapy was non-inferior to classical PPI triple therapy.
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Clinical, Journal: Comparison of the efficacy between the dual therapy of tegoprazan and the quadruple therapy of tegoprazan: A randomized, controlled, multicenter study. (Pubmed Central) - Apr 1, 2024
The TA dual therapy successfully eradicated H. pylori with a high eradication rate and a low incidence of adverse reactions. Therefore, this treatment is recommended as an alternative course for patients newly diagnosed with H. pylori infection.
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Journal: The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study. (Pubmed Central) - Mar 15, 2024
Other adverse events were negligible in both groups. : Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.
- K-CAB Tab (tegoprazan) / RaQualia, Sebela
CLINICAL OUTCOMES OF TEGOPRAZAN OR PPI COMBINATION THERAPY IN PATIENTS TAKING ANTIPLATELET AGENTS AFTER PERCUTANEOUS CORONARY INTERVENTION (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_7114;
The two groups did not differ significantly in the overall rates of GI and CV adverse events. CONCLUSIONS Tegoprazan was non-inferior to PPIs in terms of GI and CV adverse events in IHD patients receiving antiplatelet agents after PCI.
- K-CAB Tab (tegoprazan) / RaQualia, Sebela, Fexuclue (fexuprazan) / Daewoong Pharma, Takecab (vonoprazan) / Takeda, Phathom Pharma
IDENTIFICATION OF RD1305, A NEXT GENERATION POTASSIUM-COMPETITIVE ACID BLOCKER (P-CAB) FOR GASTROESOPHAGEAL REFLUX DISEASES (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5080;
In solubility assay, RD1305 expressed improving aqueous solubility (pH 6.8) 256-fold higher than existing P-CAB drugs. Conclusion Consequently, RD1305 is next generation P-CAB that improves the efficacy and physio-chemical properties of existing P-CABs.
- K-CAB Tab (tegoprazan) / RaQualia, Sebela, Takecab (vonoprazan) / Takeda, Phathom Pharma
COMPARISON OF LONG-TERM EFFECTS OF P-CAB AND PPI ON GASTRIC EMPTYING RATE, SERUM GASTRIN, AND SMALL INTESTINAL MICROBIOMES IN RATS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5061;
No significant differences were observed between PPIs and P-CABs in delayed gastric emptying, hypergastrinemia, and small intestinal dysbiosis after prolonged administration. These findings suggest that despite P-CABs exerting a more potent gastric acid inhibitory effect than PPIs, the adverse effects associated with long-term gastric acid inhibition are likely to be similar between the two drug classes.
- K-CAB Tab (tegoprazan) / RaQualia, Sebela
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PHASE III CLINICAL STUDY EVALUATING THE EFFICACY AND SAFETY OF BISMUTH QUADRUPLE THERAPY CONTAINING TEGOPRAZAN COMPARED TO ESOMEPRAZOLE IN ERADICATING HELICOBACTER PYLORI IN CHINA (140AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_4464;
This is the first phase III study to show that P-CAB-containing bismuth quadruple therapy was superior to PPI-containing bismuth quadruple therapy in overall study population. The bismuth quadruple therapy containing tegoprazan 50mg twice daily for 14 days was safe and well tolerated for treating H. pylori infection in Chinese patients.
- K-CAB Tab (tegoprazan) / RaQualia, Sebela, Mucosta oral (rebamipide oral) / Otsuka, Kubota, Dongkwang
COMPARISON OF EFFECTS OF TEGOPRAZAN AND REBAMIPIDE COMBINATION THERAPY AND TEGOPRAZAN MONOTHERAPY ON THE HEALING OF ENDOSCOPIC SUBMUCOSAL DISSECTION-INDUCED GASTRIC ULCER: A RANDOMIZED-CONTROLLED, MULTICENTER STUDY (154AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_4302;
A total of 132 lesions and 121 lesions were included in the modified intention-to-treat (mITT) and per-protocol analyses, respectively. The ulcer healing rate at 4 weeks (96.4 % vs. 93.5%, P=0.02 in the mITT analysis) was significantly higher in the combination group than tegoprazan monotherapy group, and combination therapy was a significant predictor for the higher than mean ulcer healing at 4 weeks (OR 2.28, 95% CI 1.04-5.02, P=0.04).
- Fexuclue (fexuprazan) / Daewoong Pharma
FEXUPRAZAN PROTECTS AGAINST HCL-INDUCED INFLAMMATION AND DAMAGE BY INHIBITING THE NLRP1/CASPASE-1/GASDERMIN D PYROPTOTIC PATHWAY IN THE ESOPHAGUS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_2971;
Esomeprazole, a representative PPI, and three currently marketed P-CABs (vonoprazan, tegoprazan, and fexuprazan) were pretreated. Fexuprazan inhibits inflammation and pyroptosis of esophageal cells caused by stomach acid, so it is presumed to have additional benefits in gastroesophageal reflux disease in addition to suppressing gastric acid secretion.
- TREATMENT OF HELICOBACTER PYLORI WITH POTASSIUM COMPETITIVE ACID BLOCKERS: A SYSTEMATIC REVIEW AND META-ANALYSIS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_993;
Vonoprazan-based triple therapy outperformed conventional PPI-based triple therapy in eradicating H. pylori, positioning it as a highly effective first-line regimen. Additionally, Tegoprazan-based triple therapy wass non-inferior to classical PPI triple therapy.
- Takecab (vonoprazan) / Takeda, Phathom Pharma
COMPARATIVE EFFICACY OF VONOPRAZAN WITH PROTON PUMP INHIBITORS AND OTHER POTASSIUM-COMPETITIVE ACID BLOCKERS FOR REFLUX ESOPHAGITIS: A NETWORK META-ANALYSIS (ePosters - DDW Online Platform) - Mar 14, 2024 - Abstract #DDW2024DDW_529;
Randomized controlled trials of (1) endoscopy-confirmed RE patients ?18 years, (2) receiving at least 2 of these intervention arms: vonoprazan, tegoprazan, kenoprazan, fexuprazan, linaprazan glurate and/or any oral PPIs, (3) reporting at least 1 clinical outcomes of healing rate at 4 weeks for vonoprazan, and 8 weeks for PPIs and other P-CABs and (4) those including >20 patients per group were considered...Specifically, ORs (95% CrI) of PPIs and other P-CABs versus vonoprazan were as follows: fexuprazan 40mg:2.0 (0.056,80.0), keverprazan 20mg:3.6 (0.96,15.0), tegoprazan 50mg:3.4 (0.76,17.0), esomeprazole 20mg:1.7 (0.69,4.1), esomeprazole 40mg:1.8 (0.94,3.4), ilaprazole 10mg:2.1 (0.91,4.8), lansoprazole 30mg:1.4 (0.76,2.4), omeprazole 20mg:1.2 (0.63,2.4), omeprazole 40mg:1.3 (0.53,3.1), pantoprazole 40mg:1.4 (0.70,2.8), and rabeprazole 20mg:1.0 (0.42, 2.3) (Figure 1)...Conclusion This is the first study showing similar efficacy of 4-week vonoprazan course to 8-week PPI course and other P-CABs in healing RE. These results may be helpful to inform clinical practice.
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Journal, HEOR, Real-world evidence, Real-world: Bismuth add-on improves the efficacy of 2-week tegoprazan-based triple therapy for first-line Helicobacter pylori eradication: a real-world evidence study. (Pubmed Central) - Mar 9, 2024
No use of bismuth was significantly associated with eradication failure (p?=?0.038). The bismuth add-on increased the first-line H. pylori eradication rate of 2-week TPZ-based triple therapy.
- || Retrospective data, Review, Journal: Acid-suppressive drugs: A systematic review and network meta-analysis of their nocturnal acid-inhibitory effect. (Pubmed Central) - Feb 19, 2024
Overall, in terms of nocturnal acid-inhibitory effect, vonoprazan and tegoprazan had an advantage against other regimens including H2RAs, isomer PPIs, traditional PPIs, AHB, and new PPIs. Even in some subgroups, such as language classification (English), types of study design (crossover-RCT), age (?40?years), BMI (18.5-24.9?kg/m2 ), continent (Asia and North America), disease status (health), the duration of therapy (2?weeks), and time of administration (at daytime or at night-time), the nocturnal acid-inhibitory effect of vonoprazan or tegoprazan were better than most regimens, even AHB and new PPIs.
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis (clinicaltrials.gov) - Feb 15, 2024
P3, N=1250, Recruiting, Sponsor: Braintree Laboratories
Even in some subgroups, such as language classification (English), types of study design (crossover-RCT), age (?40?years), BMI (18.5-24.9?kg/m2 ), continent (Asia and North America), disease status (health), the duration of therapy (2?weeks), and time of administration (at daytime or at night-time), the nocturnal acid-inhibitory effect of vonoprazan or tegoprazan were better than most regimens, even AHB and new PPIs. Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Dec 2024 --> Jun 2024
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela, Takecab (vonoprazan) / Takeda, Phathom Pharma
Retrospective data, Review, Journal: Comparative efficacy of P-CABs versus proton pump inhibitors for Grade C/D esophagitis: A systematic review and network meta-analysis. (Pubmed Central) - Feb 12, 2024
Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Dec 2024 --> Jun 2024 Vonoprazan has considerable efficacy in initial and maintained healing of grade C/D esophagitis compared with PPIs, with moderate short-term and long-term safety.
- || lansoprazole / Generic mfg.
Clinical, Retrospective data, Review: Comparative efficiency and safety of potassium competitive acid blockers versus Lansoprazole in peptic ulcer: a systematic review and meta-analysis. (Pubmed Central) - Jan 26, 2024
Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=458361 Identifier: PROSPERO (No. CRD42023458361).
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease (clinicaltrials.gov) - Jan 24, 2024
P3, N=400, Enrolling by invitation, Sponsor: Braintree Laboratories
CRD42023458361). Trial completion date: Sep 2024 --> Feb 2025 | Trial primary completion date: Mar 2024 --> Oct 2024
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease (clinicaltrials.gov) - Jan 24, 2024
P3, N=800, Active, not recruiting, Sponsor: Braintree Laboratories
Trial completion date: Sep 2024 --> Feb 2025 | Trial primary completion date: Mar 2024 --> Oct 2024 Trial completion date: May 2024 --> Nov 2024 | Trial primary completion date: Jan 2024 --> May 2024
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis (clinicaltrials.gov) - Jan 23, 2024
P3, N=1250, Recruiting, Sponsor: Braintree Laboratories
Trial completion date: May 2024 --> Nov 2024 | Trial primary completion date: Jan 2024 --> May 2024 Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Jun 2024 --> Dec 2024
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Clinical, Journal: Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: rationale and design of an open-label, multicenter, randomized controlled trial. (Pubmed Central) - Dec 26, 2023
This study will demonstrate that the 7-day or 14-day PC-BMT is well tolerated and achieve similar eradication rates to those of 14-day P-BMT. Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration.
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela, Takecab (vonoprazan) / Takeda, Phathom Pharma
Journal: The role of potassium-competitive acid blockers in the treatment of acid-related digestive diseases (Pubmed Central) - Dec 18, 2023
Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration. No abstract available
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects (clinicaltrials.gov) - Dec 11, 2023
P1, N=48, Not yet recruiting, Sponsor: HK inno.N Corporation
- ||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers (clinicaltrials.gov) - Dec 10, 2023
P1, N=87, Completed, Sponsor: HK inno.N Corporation
No abstract available Not yet recruiting --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Journal: Comparative efficacy of tegoprazan versus esomeprazole/sodium bicarbonate for the treatment of Helicobacter pylori infection. (Pubmed Central) - Nov 30, 2023
The efficacy of the esomeprazole/sodium bicarbonate-based triple therapy for H. pylori eradication was comparable with that of the tegoprazan-based triple therapy. However, esomeprazole/sodium bicarbonate-based therapy exhibited a higher risk of abdominal discomfort and diarrhea than tegoprazan-based therapy.
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open, Head-to-Head: Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori?SHARE2302) (clinicaltrials.gov) - Nov 14, 2023
P=N/A, N=254, Recruiting, Sponsor: Shandong University
However, esomeprazole/sodium bicarbonate-based therapy exhibited a higher risk of abdominal discomfort and diarrhea than tegoprazan-based therapy. Not yet recruiting --> Recruiting
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Journal: Anti-Inflammatory Effects of Tegoprazan in Lipopolysaccharide-Stimulated Bone-Marrow-Derived Macrophages. (Pubmed Central) - Nov 3, 2023
In other words, TEGO suppressed the various pro-inflammatory responses in LPS-induced BMMs. These results show that TEGO has the potential to be used as an anti-inflammatory agent.
- ||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment closed: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease (clinicaltrials.gov) - Oct 24, 2023
P3, N=800, Active, not recruiting, Sponsor: Braintree Laboratories
These results show that TEGO has the potential to be used as an anti-inflammatory agent. Recruiting --> Active, not recruiting
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Journal: Efficacy of Tegoprazan in Patients with Laryngopharyngeal Reflux Disease: A Preliminary Feasibility Study. (Pubmed Central) - Oct 14, 2023
P3
Considering the potential effectiveness of tegoprazan as an acid-suppressing therapy and the possibility of type II error due to a low number of included patients herein, prospective, large-scale, multi-center studies with a higher dose of tegoprazan for a prolonged duration are required to elucidate the efficacy of tegoprazan in patients with LPRD. (ClinicalTrials.gov: NCT05871398).
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Sep 21, 2023
P4, N=3100, Recruiting, Sponsor: Duk-Woo Park, MD
(ClinicalTrials.gov: NCT05871398). Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Sep 2025 --> Sep 2026
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Journal: Is Tegoprazan-Based Triple Therapy Effective in Regions with High Rates of Clarithromycin Resistance? (Pubmed Central) - Sep 19, 2023
Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Sep 2025 --> Sep 2026 No abstract available
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New trial, Head-to-Head: Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori?SHARE2302) (clinicaltrials.gov) - Aug 18, 2023
P=N/A, N=254, Not yet recruiting, Sponsor: Shandong University
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Preclinical, Journal: Carcinogenicity assessment of tegoprazan in Sprague-Dawley (Crl:CD) rats and ICR (Crl:CD1) mice. (Pubmed Central) - Jul 17, 2023
Overall, tegoprazan induced gastric enterochromaffin-like (ECL) cell tumors in SD rats, but did not produce any treatment-related statistically significant increase in the incidence of neoplasms relevant to humans when administered to SD rats and CD-1 mice by gavage at doses up to 300 and 150 mg/kg/day, respectively. Gastric ECL cell tumors are thought to be induced by the exaggerated indirect pharmacological effect of tegoprazan, similar to that reported for proton pump inhibitors (PPIs) and other P-CABs.
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
PK/PD data, Journal: Evaluation of pharmacokinetic drug-drug interaction between tegoprazan and clarithromycin in healthy subjects. (Pubmed Central) - Jul 13, 2023
P1
It is suggested that an in-depth analysis of the concentration-response relationship is necessary to determine whether these concentration changes warrant clinical action. ClinicalTrials.gov Identifier: NCT02052336.
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection ?SHARE2301? (clinicaltrials.gov) - Jul 12, 2023
P=N/A, N=368, Recruiting, Sponsor: Yanqing Li
ClinicalTrials.gov Identifier: NCT02052336. Not yet recruiting --> Recruiting
- K-CAB Tab (tegoprazan) / RaQualia, Sebela
EFFICACY OF TEGOPRAZAN IN PATIENTS WITH FUNCTIONAL DYSPEPSIA ; A PROSPECTIVE, MULTICENTER, SINGLE-ARM STUDY (Science Lounge) - Jul 8, 2023 - Abstract #UEGW2023UEGW_2900;
- ||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P2 trial: Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients (clinicaltrials.gov) - Jul 6, 2023
P2, N=381, Recruiting, Sponsor: HK inno.N Corporation
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
PK/PD data, Journal: Evaluation of the comparative pharmacokinetic properties of a new orally disintegrating tablet of tegoprazan in healthy Korean subjects. (Pubmed Central) - Jun 29, 2023
There was no significant difference in the safety profiles. Therefore, the novel ODT of tegoprazan that can be taken without water may improve compliance among patients with acid-related diseases.
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin (clinicaltrials.gov) - Jun 23, 2023
P1, N=22, Completed, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- |||||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease (clinicaltrials.gov) - Jun 5, 2023
P3, N=400, Enrolling by invitation, Sponsor: Braintree Laboratories
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans (clinicaltrials.gov) - May 31, 2023
P1, N=6, Completed, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New trial: Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection ?SHARE2301? (clinicaltrials.gov) - May 23, 2023
P=N/A, N=368, Not yet recruiting, Sponsor: Yanqing Li
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease (clinicaltrials.gov) - May 23, 2023
P3, N=36, Completed, Sponsor: Pusan National University Hospital
- ||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer (clinicaltrials.gov) - Apr 25, 2023
P3, N=400, Completed, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Therefore, the novel ODT of tegoprazan that can be taken without water may improve compliance among patients with acid-related diseases. Recruiting --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial initiation date, Trial primary completion date: 14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection (clinicaltrials.gov) - Feb 14, 2023
P4, N=258, Not yet recruiting, Sponsor: Shandong University
Recruiting --> Completed Trial completion date: Jun 2023 --> Dec 2023 | Initiation date: Jun 2022 --> Feb 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers (clinicaltrials.gov) - Feb 10, 2023
P1, N=76, Not yet recruiting, Sponsor: HK inno.N Corporation
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs (clinicaltrials.gov) - Jan 27, 2023
P3, N=390, Recruiting, Sponsor: HK inno.N Corporation
Trial completion date: Jun 2023 --> Dec 2023 | Initiation date: Jun 2022 --> Feb 2023 | Trial primary completion date: Dec 2022 --> Dec 2023 Trial completion date: Jan 2023 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Jun 2024