{"id":"vonoprazan-amoxicillin-dual-therapy","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Allergic reactions (amoxicillin-related)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Vonoprazan is a potassium-competitive acid blocker (PCAB) that suppresses gastric acid production by inhibiting the H+/K+-ATPase pump, creating an environment hostile to acid-dependent pathogens and allowing antibiotics to work more effectively. Amoxicillin is a beta-lactam antibiotic that disrupts bacterial cell wall synthesis. Together, this dual therapy achieves high H. pylori eradication rates by combining acid suppression with direct bactericidal activity.","oneSentence":"Vonoprazan inhibits gastric acid secretion while amoxicillin kills Helicobacter pylori bacteria, together eradicating H. pylori infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:15:44.228Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Helicobacter pylori infection eradication"}]},"trialDetails":[{"nctId":"NCT07179159","phase":"NA","title":"Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial","status":"RECRUITING","sponsor":"Yanqing Li","startDate":"2025-09-09","conditions":"HELICOBACTER PYLORI INFECTIONS","enrollment":372},{"nctId":"NCT06412588","phase":"NA","title":"Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.","status":"COMPLETED","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2024-06-15","conditions":"Helicobacter Pylori Infection","enrollment":579},{"nctId":"NCT06340724","phase":"PHASE3","title":"Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication","status":"COMPLETED","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2024-02-15","conditions":"Helicobacter Pylori Infection","enrollment":104},{"nctId":"NCT06156085","phase":"PHASE4","title":"Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy","status":"COMPLETED","sponsor":"Fu Jen Catholic University Hospital","startDate":"2023-11-14","conditions":"Helicobacter Pylori Infection","enrollment":337},{"nctId":"NCT07352098","phase":"NA","title":"7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori","status":"NOT_YET_RECRUITING","sponsor":"Yueyue Li","startDate":"2026-02-01","conditions":"Helicobacter","enrollment":290},{"nctId":"NCT06349486","phase":"NA","title":"Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication","status":"RECRUITING","sponsor":"Kaohsiung Medical University","startDate":"2023-11-28","conditions":"Helicobacter Pylori Eradication","enrollment":390},{"nctId":"NCT07333001","phase":"","title":"Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication","status":"COMPLETED","sponsor":"Yueyue Li","startDate":"2025-11-01","conditions":"HELICOBACTER PYLORI INFECTIONS","enrollment":508},{"nctId":"NCT07306988","phase":"PHASE4","title":"Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.","status":"RECRUITING","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2025-04-17","conditions":"HELICOBACTER PYLORI INFECTIONS, Metabolic Syndrome","enrollment":120},{"nctId":"NCT07242456","phase":"PHASE2, PHASE3","title":"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","status":"RECRUITING","sponsor":"First People's Hospital of Hangzhou","startDate":"2025-02-17","conditions":"Helicobacter Pylori Infection","enrollment":240},{"nctId":"NCT07232095","phase":"PHASE4","title":"7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2025-11-30","conditions":"Helicobacter Pylori","enrollment":316},{"nctId":"NCT04728516","phase":"PHASE4","title":"The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients","status":"RECRUITING","sponsor":"Qilu Hospital of Shandong University","startDate":"2023-04-12","conditions":"Acute Coronary Syndrome, Helicobacter Pylori Infection","enrollment":2600},{"nctId":"NCT05874544","phase":"PHASE4","title":"Rescue Therapy for Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2023-05-16","conditions":"Helicobacter Pylori Infection","enrollment":360},{"nctId":"NCT07159412","phase":"NA","title":"Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis","status":"NOT_YET_RECRUITING","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2025-08-31","conditions":"Helicobacter Pylori Infection, Metabolic-associated Steatohepatitis, High-dose Dual Therapy","enrollment":286},{"nctId":"NCT07068607","phase":"PHASE4","title":"Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial","status":"RECRUITING","sponsor":"Yongquan Shi","startDate":"2025-04-01","conditions":"Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer","enrollment":400},{"nctId":"NCT06168084","phase":"PHASE4","title":"Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy","status":"COMPLETED","sponsor":"Yongquan Shi","startDate":"2023-06-06","conditions":"Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer","enrollment":688},{"nctId":"NCT06929962","phase":"PHASE4","title":"VA Dual Sequential Therapy","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2025-04-24","conditions":"Helicobacter Pylori Infection","enrollment":600},{"nctId":"NCT06292546","phase":"NA","title":"The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment","status":"COMPLETED","sponsor":"Zhongshan Hospital (Xiamen), Fudan University","startDate":"2024-01-31","conditions":"Gut Microbiota, Metabolic Disturbance, Helicobacter Pylori Eradication","enrollment":72},{"nctId":"NCT06901375","phase":"EARLY_PHASE1","title":"Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication","status":"NOT_YET_RECRUITING","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2025-05","conditions":"Helicobacter Pylori Infection","enrollment":136},{"nctId":"NCT06881524","phase":"NA","title":"Low-Dose Amoxicillin Dual-Therapy Combined with Licorice and Lotus Root Powder Helicobacter Pylori Treatment","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-04-01","conditions":"HELICOBACTER PYLORI INFECTIONS","enrollment":374},{"nctId":"NCT06811207","phase":"PHASE3","title":"Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2025-02-01","conditions":"HELICOBACTER PYLORI INFECTIONS","enrollment":300},{"nctId":"NCT05901051","phase":"PHASE4","title":"High-dose Dual Therapy with Different Administration Frequencies","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2021-03-30","conditions":"Helicobacter Pylori Infection","enrollment":327},{"nctId":"NCT06561698","phase":"PHASE4","title":"High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection","status":"RECRUITING","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2024-08-21","conditions":"Helicobacter Pylori Infection","enrollment":200},{"nctId":"NCT05649540","phase":"PHASE4","title":"Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori","status":"COMPLETED","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2023-01-20","conditions":"Helicobacter Pylori Infection","enrollment":900},{"nctId":"NCT06162949","phase":"PHASE3","title":"Vonoprazan for Helicobacter Pylori Eradication in Adolescents","status":"COMPLETED","sponsor":"Alexandria University","startDate":"2024-01-01","conditions":"Treatment Effectiveness","enrollment":242},{"nctId":"NCT05649709","phase":"PHASE4","title":"Helicobacter Pylori and Vonoprazan Dual Therapy","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Nanchang University","startDate":"2023-02-13","conditions":"Helicobacter Pylori","enrollment":504},{"nctId":"NCT06168214","phase":"PHASE4","title":"Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication","status":"RECRUITING","sponsor":"Xijing Hospital of Digestive Diseases","startDate":"2023-09-04","conditions":"the Eradication Rates of Helicobacter Pylori","enrollment":1404},{"nctId":"NCT05749081","phase":"PHASE4","title":"Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"The First Affiliated Hospital of Nanchang University","startDate":"2023-05-13","conditions":"Helicobacter Pylori Infection","enrollment":324},{"nctId":"NCT05469685","phase":"PHASE4","title":"Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication","status":"COMPLETED","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2022-08-01","conditions":"Helicobacter Pylori Infection","enrollment":914},{"nctId":"NCT06250634","phase":"NA","title":"Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"The Third Xiangya Hospital of Central South University","startDate":"2024-02-10","conditions":"Helicobacter Pylori Infection","enrollment":806},{"nctId":"NCT05719831","phase":"PHASE3","title":"Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection","status":"COMPLETED","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","startDate":"2023-02-01","conditions":"Helicobacter Pylori Eradication Rate","enrollment":516},{"nctId":"NCT04198363","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Takeda","startDate":"2020-04-30","conditions":"Helicobacter Pylori","enrollment":510},{"nctId":"NCT04753437","phase":"PHASE1","title":"A Study of Vonoprazan in Adults With Helicobacter Pylori","status":"COMPLETED","sponsor":"Takeda","startDate":"2021-04-06","conditions":"Helicobacter Pylori","enrollment":44},{"nctId":"NCT06004401","phase":"NA","title":"The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori","status":"UNKNOWN","sponsor":"Shanghai Changzheng Hospital","startDate":"2023-08-20","conditions":"The Eradication Rate of Helicobacter Pylori","enrollment":400},{"nctId":"NCT05419674","phase":"PHASE4","title":"Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2022-08-01","conditions":"Helicobacter Pylori Infection","enrollment":393},{"nctId":"NCT05658055","phase":"PHASE4","title":"The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication","status":"UNKNOWN","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2023-06-01","conditions":"Helicobacter Pylori Infection, Infections, Intestinal Bacteria Flora Disturbance","enrollment":100},{"nctId":"NCT04167670","phase":"PHASE3","title":"Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Phathom Pharmaceuticals, Inc.","startDate":"2019-12-10","conditions":"Helicobacter Pylori Infection","enrollment":1046},{"nctId":"NCT05191888","phase":"PHASE4","title":"14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy","status":"UNKNOWN","sponsor":"Kaohsiung Medical University","startDate":"2021-08-06","conditions":"Helicobacter Pylori Eradication","enrollment":906},{"nctId":"NCT04901663","phase":"PHASE4","title":"Vonoprazan in Helicobacter Pylori Treatment an RCT","status":"COMPLETED","sponsor":"Dow University of Health Sciences","startDate":"2021-06-21","conditions":"Helicobacter Pylori Infection","enrollment":179},{"nctId":"NCT03050307","phase":"PHASE3","title":"Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Takeda","startDate":"2017-04-17","conditions":"Gastric Ulcer","enrollment":234},{"nctId":"NCT03050359","phase":"PHASE3","title":"Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Takeda","startDate":"2017-04-05","conditions":"Duodenal Ulcer","enrollment":533},{"nctId":"NCT02827942","phase":"PHASE3","title":"Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication","status":"COMPLETED","sponsor":"Hamamatsu University","startDate":"2016-07-01","conditions":"Gastritis Associated With Helicobacter Pylori","enrollment":112}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":41,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Vonoprazan-Amoxicillin Dual Therapy","genericName":"Vonoprazan-Amoxicillin Dual Therapy","companyName":"Nanjing First Hospital, Nanjing Medical University","companyId":"nanjing-first-hospital-nanjing-medical-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Vonoprazan inhibits gastric acid secretion while amoxicillin kills Helicobacter pylori bacteria, together eradicating H. pylori infection. Used for Helicobacter pylori infection eradication.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}