{"id":"medi8897","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MEDI8897 binds to the RSV fusion (F) protein and prevents viral entry into host cells. The antibody incorporates MedImmune's proprietary half-life extension technology to provide prolonged protection against RSV infection, particularly in vulnerable populations such as infants and elderly patients.","oneSentence":"MEDI8897 is a monoclonal antibody that provides extended half-life neutralization of respiratory syncytial virus (RSV) through engineered Fc region modifications.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:31.188Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of respiratory syncytial virus (RSV) disease in infants born during RSV season"},{"name":"Prevention of RSV disease in older adults"}]},"trialDetails":[{"nctId":"NCT05110261","phase":"PHASE3","title":"Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2021-11-24","conditions":"Lower Respiratory Tract Infection","enrollment":800},{"nctId":"NCT06042049","phase":"PHASE3","title":"A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2023-07-27","conditions":"Respiratory Syncytial Virus Infections","enrollment":33},{"nctId":"NCT03979313","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2019-07-23","conditions":"Respiratory Syncytial Virus Infections","enrollment":3012},{"nctId":"NCT04484935","phase":"PHASE2","title":"Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-08-19","conditions":"RSV Infection","enrollment":100},{"nctId":"NCT04840849","phase":"PHASE1","title":"Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-06-22","conditions":"Evaluate PK Profile","enrollment":24},{"nctId":"NCT03959488","phase":"PHASE2, PHASE3","title":"A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2019-07-30","conditions":"Respiratory Syncytial Virus Infections","enrollment":925},{"nctId":"NCT02878330","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2016-11-03","conditions":"Respiratory Syncytial Virus Infections","enrollment":1453},{"nctId":"NCT02290340","phase":"PHASE1","title":"A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2015-01-13","conditions":"Respiratory Syncytial Virus","enrollment":151},{"nctId":"NCT02114268","phase":"PHASE1","title":"A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2014-04","conditions":"Respiratory Syncytial Virus Infections","enrollment":342}],"_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":[],"phase":"phase_3","status":"active","brandName":"MEDI8897","genericName":"MEDI8897","companyName":"MedImmune LLC","companyId":"medimmune-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MEDI8897 is a monoclonal antibody that provides extended half-life neutralization of respiratory syncytial virus (RSV) through engineered Fc region modifications. Used for Prevention of respiratory syncytial virus (RSV) disease in infants born during RSV season, Prevention of RSV disease in older adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}