{"id":"cefepime-zidebactam-fep-zid","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Phlebitis at infusion site"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":{"chemblId":"CHEMBL186","moleculeType":"Small molecule","molecularWeight":"480.57"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cefepime acts as a beta-lactam antibiotic by inhibiting bacterial cell wall synthesis. Zidebactam is a non-beta-lactam beta-lactamase inhibitor that protects cefepime from degradation by serine beta-lactamases, including extended-spectrum beta-lactamases (ESBLs) and AmpC beta-lactamases. This combination extends cefepime's spectrum to cover resistant gram-negative pathogens including Pseudomonas aeruginosa and Enterobacteriaceae with acquired resistance mechanisms.","oneSentence":"Cefepime-zidebactam is a combination of a fourth-generation cephalosporin (cefepime) and a novel beta-lactamase inhibitor (zidebactam) that together restore cefepime's activity against beta-lactamase-producing gram-negative bacteria.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:39.521Z","_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)"},{"name":"Complicated intra-abdominal infections (cIAI)"}]},"trialDetails":[{"nctId":"NCT04979806","phase":"PHASE3","title":"Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)","status":"COMPLETED","sponsor":"Wockhardt","startDate":"2022-08-28","conditions":"Complicated Urinary Tract Infection, Acute Pyelonephritis","enrollment":530},{"nctId":"NCT06806995","phase":"PHASE1","title":"A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.","status":"COMPLETED","sponsor":"Wockhardt","startDate":"2025-01-21","conditions":"PHA1A","enrollment":30},{"nctId":"NCT03630094","phase":"PHASE1","title":"Plasma and Intrapulmonary Concentrations Study of WCK 5222","status":"COMPLETED","sponsor":"Wockhardt","startDate":"2017-03-31","conditions":"PHA1A","enrollment":36},{"nctId":"NCT02942810","phase":"PHASE1","title":"To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment","status":"COMPLETED","sponsor":"Wockhardt","startDate":"2016-10-25","conditions":"Renal Impairment","enrollment":48},{"nctId":"NCT03554304","phase":"PHASE1","title":"Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers","status":"COMPLETED","sponsor":"Wockhardt","startDate":"2017-02-09","conditions":"QT/QTc Interval in Healthy Volunteers","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Cefepime-zidebactam (FEP-ZID)","genericName":"Cefepime-zidebactam (FEP-ZID)","companyName":"Wockhardt","companyId":"wockhardt","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Cefepime-zidebactam is a combination of a fourth-generation cephalosporin (cefepime) and a novel beta-lactamase inhibitor (zidebactam) that together restore cefepime's activity against beta-lactamase-producing gram-negative bacteria. Used for Complicated urinary tract infections (cUTI) caused by susceptible gram-negative bacteria, Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), Complicated intra-abdominal infections (cIAI).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}