{"id":"dexlansoprazole-mr","safety":{"commonSideEffects":[{"rate":"12-15","effect":"Headache"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-8","effect":"Abdominal pain"},{"rate":"4-7","effect":"Nausea"},{"rate":"3-5","effect":"Upper respiratory tract infection"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dexlansoprazole is the active R-enantiomer of lansoprazole, a proton pump inhibitor (PPI). It binds to and inactivates the proton pump (H+/K+-ATPase) on the secretory surface of gastric parietal cells, reducing both basal and stimulated gastric acid production. The modified-release (MR) formulation provides dual-peak plasma concentrations to extend acid suppression throughout the day.","oneSentence":"Dexlansoprazole is a proton pump inhibitor that suppresses gastric acid secretion by irreversibly blocking the H+/K+-ATPase enzyme in parietal cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:09:18.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Gastroesophageal reflux disease (GERD)"},{"name":"Healing of erosive esophagitis"},{"name":"Maintenance of healed erosive esophagitis"}]},"trialDetails":[{"nctId":"NCT02646332","phase":"NA","title":"Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy","status":"COMPLETED","sponsor":"Kaohsiung Veterans General Hospital.","startDate":"2015-12","conditions":"Helicobacter Pylori Infection","enrollment":248},{"nctId":"NCT04311541","phase":"","title":"A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation","status":"WITHDRAWN","sponsor":"Takeda","startDate":"2020-03-15","conditions":"Gastroesophageal Reflux Disease","enrollment":""},{"nctId":"NCT03829150","phase":"NA","title":"Dexlansoprazole MR-Based Concomitant Quadruple Therapy","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2017-03-01","conditions":"Helicobacter Pylori Infection","enrollment":202},{"nctId":"NCT00255190","phase":"PHASE3","title":"Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-01","conditions":"Gastroesophageal Reflux Disease","enrollment":591},{"nctId":"NCT02541786","phase":"PHASE4","title":"Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Kaohsiung Medical University","startDate":"2015-01","conditions":"Helicobacter Pylori Infection","enrollment":177},{"nctId":"NCT02490449","phase":"NA","title":"Dexlansoprazole MR in Nonerosive Reflux Disease","status":"UNKNOWN","sponsor":"Soonchunhyang University Hospital","startDate":"2014-12","conditions":"Nonerosive Reflux Disease","enrollment":356},{"nctId":"NCT00321737","phase":"PHASE3","title":"Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-05","conditions":"Esophagitis, Reflux, Esophagitis, Peptic","enrollment":445},{"nctId":"NCT00251693","phase":"PHASE3","title":"Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-12","conditions":"Esophagitis, Reflux, Esophagitis, Peptic","enrollment":2038},{"nctId":"NCT00255151","phase":"PHASE3","title":"Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-01","conditions":"Esophagitis, Reflux, Esophagitis, Peptic","enrollment":451},{"nctId":"NCT00847808","phase":"PHASE3","title":"Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-02","conditions":"Gastroesophageal Reflux","enrollment":178},{"nctId":"NCT00251719","phase":"PHASE3","title":"Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-12","conditions":"Esophagitis, Reflux, Esophagitis, Peptic","enrollment":2054},{"nctId":"NCT00255164","phase":"PHASE3","title":"Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-01","conditions":"Esophagitis, Reflux, Esophagitis, Peptic","enrollment":451},{"nctId":"NCT00847210","phase":"PHASE1","title":"Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-05","conditions":"Gastroesophageal Reflux","enrollment":36},{"nctId":"NCT00321984","phase":"PHASE3","title":"Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-06","conditions":"Gastroesophageal Reflux Disease","enrollment":947},{"nctId":"NCT00251745","phase":"PHASE3","title":"Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-12","conditions":"Gastroesophageal Reflux Disease","enrollment":908},{"nctId":"NCT00251758","phase":"PHASE3","title":"Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-12","conditions":"Gastroesophageal Reflux Disease","enrollment":908}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":32,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["TAK-390MR","Kapidex","Dexilant"],"phase":"phase_3","status":"active","brandName":"Dexlansoprazole MR","genericName":"Dexlansoprazole MR","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Dexlansoprazole MR is a small molecule that inhibits the potassium-transporting ATPase, a mechanism that is used to treat conditions such as gastroesophageal reflux disease and peptic esophagitis. It is indicated for the treatment of heartburn and other conditions associated with gastroesophageal reflux disease, as well as Helicobacter pylori infection.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2009-01-30T00:00:00.000Z","mah":"TAKEDA PHARMS USA","brand_name_local":"DEXILANT","application_number":"NDA022287"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}