{"id":"vimovo-500-20","safety":{"commonSideEffects":[{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Gastric ulcer (reduced vs. NSAID alone)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Esomeprazole suppresses gastric acid secretion by inhibiting the H+/K+-ATPase pump, protecting the gastric mucosa from NSAID-related damage and ulceration.","oneSentence":"VIMOVO combines naproxen (an NSAID) with esomeprazole (a proton pump inhibitor) to reduce pain and inflammation while protecting the stomach from NSAID-induced ulcers.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:39:33.696Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients at risk for NSAID-induced gastric ulcers"}]},"trialDetails":[{"nctId":"NCT01544114","phase":"PHASE4","title":"A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-04","conditions":"Juvenile Idiopathic Arthritis (JIA)","enrollment":46},{"nctId":"NCT00664560","phase":"PHASE3","title":"Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-04","conditions":"Osteoarthritis","enrollment":614},{"nctId":"NCT00665431","phase":"PHASE3","title":"Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-04","conditions":"Osteoarthritis","enrollment":610},{"nctId":"NCT01331993","phase":"PHASE1","title":"A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-09","conditions":"Healthy Volunteers, Bioequivalence","enrollment":36},{"nctId":"NCT01129011","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen","status":"COMPLETED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":420},{"nctId":"NCT00527787","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen","status":"COMPLETED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":434},{"nctId":"NCT00594854","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec","status":"TERMINATED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":20},{"nctId":"NCT00527904","phase":"PHASE3","title":"A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)","status":"COMPLETED","sponsor":"POZEN","startDate":"2007-03","conditions":"Gastric Ulcer","enrollment":239},{"nctId":"NCT00992381","phase":"PHASE1","title":"Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-09","conditions":"Healthy","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["naproxen/esomeprazole"],"phase":"marketed","status":"active","brandName":"VIMOVO 500/20","genericName":"VIMOVO 500/20","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"VIMOVO combines naproxen (an NSAID) with esomeprazole (a proton pump inhibitor) to reduce pain and inflammation while protecting the stomach from NSAID-induced ulcers. Used for Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients at risk for NSAID-induced gastric ulcers.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}