{"id":"imi-rel-fdc","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Phlebitis at infusion site"},{"rate":null,"effect":"Seizures"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Imipenem is a broad-spectrum beta-lactam antibiotic that inhibits bacterial cell wall synthesis. Relebactam is a non-beta-lactam beta-lactamase inhibitor that protects imipenem from degradation by serine beta-lactamases, including extended-spectrum beta-lactamases (ESBLs) and carbapenem-hydrolyzing class A beta-lactamases. This combination restores imipenem's activity against resistant gram-negative bacteria.","oneSentence":"IMI/REL is a fixed-dose combination of imipenem (a carbapenem antibiotic) and relebactam (a beta-lactamase inhibitor) that works together to overcome bacterial resistance mechanisms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:18.026Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Complicated urinary tract infections (cUTI) caused by susceptible gram-negative bacteria"},{"name":"Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible gram-negative bacteria"}]},"trialDetails":[{"nctId":"NCT03583333","phase":"PHASE3","title":"Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-09-18","conditions":"Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia","enrollment":274},{"nctId":"NCT03230916","phase":"PHASE1","title":"A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2017-11-06","conditions":"Suspected or Documented Gram-negative Bacterial Infection","enrollment":47},{"nctId":"NCT02493764","phase":"PHASE3","title":"Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-11-24","conditions":"Bacterial Pneumonia","enrollment":537}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["MK-7655A"],"phase":"phase_3","status":"active","brandName":"IMI/REL FDC","genericName":"IMI/REL FDC","companyName":"Merck Sharp & Dohme LLC","companyId":"merck-sharp-dohme-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IMI/REL is a fixed-dose combination of imipenem (a carbapenem antibiotic) and relebactam (a beta-lactamase inhibitor) that works together to overcome bacterial resistance mechanisms. Used for Complicated urinary tract infections (cUTI) caused by susceptible gram-negative bacteria, Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible gram-negative bacteria.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}