{"id":"tixagevimab","rwe":[],"tags":[{"label":"Monoclonal Antibody","category":"modality"},{"label":"J06BD03","category":"atc"},{"label":"Active","category":"status"},{"label":"COVID-19","category":"indication"},{"label":"AstraZeneca AB","category":"company"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"AstraZeneca","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TIXAGEVIMAB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:17:08.465042+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Tixagevimab","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:17:15.687662+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:17:14.215516+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:17:08.537154+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TIXAGEVIMAB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:17:14.637110+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Spike glycoprotein blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:17:15.687588+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4650265/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:17:15.348264+00:00"}},"allNames":"evusheld","offLabel":[],"synonyms":["tixagevimab","tixagevimab (genetical recombination)","AZD8895","COV2-2196","evusheld"],"timeline":[{"date":"2022-03-25","type":"positive","source":"DrugCentral","milestone":"EMA approval (AstraZeneca AB)"},{"date":"2022-08-30","type":"positive","source":"DrugCentral","milestone":"PMDA approval (AstraZeneca K.K.)"}],"approvals":[{"date":"2022-03-25","orphan":false,"company":"AstraZeneca AB","regulator":"EMA"},{"date":"2022-08-30","orphan":false,"company":"AstraZeneca K.K.","regulator":"PMDA"}],"brandName":"Evusheld","ecosystem":[{"indication":"COVID-19","otherDrugs":[{"name":"bamlanivimab","slug":"bamlanivimab","company":"Eli Lilly and Company"},{"name":"casirivimab","slug":"casirivimab","company":"Regeneron Pharmaceuticals, Inc."},{"name":"etesevimab","slug":"etesevimab","company":"Eli Lilly and Company"},{"name":"imdevimab","slug":"imdevimab","company":"Regeneron Pharmaceuticals, Inc."}],"globalPrevalence":null}],"mechanism":{"modality":"Monoclonal Antibody","explanation":"","oneSentence":"","technicalDetail":"Evusheld is a monoclonal antibody that targets the SARS-CoV-2 spike protein, specifically the SARS-CoV-2 spike protein variant BA.1. It binds to the spike protein, preventing the virus from fusing with host cells and initiating infection."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Tixagevimab%2Fcilgavimab","title":"Tixagevimab/cilgavimab","extract":"Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections.","wiki_society_and_culture":"== Society and culture ==\n\n=== Legal status ===\nIn October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of tixagevimab/cilgavimab, which is being developed by AstraZeneca AB, for the prevention of COVID-19 in adults. It was approved for medical use in the European Union in March 2022.\n\nIn November 2021, Bahrain authorized it for emergency use.\n\nIn December 2021, the US FDA granted emergency use authorization (EUA) of this combination to prevent COVID-19 (before exposure) in people with weakened immunity or who cannot be fully vaccinated due to a history of severe reaction to coronavirus vaccines. The EUA was revoked in January 2023. It has since been granted approval for use in the UK and in the European Union.\n\nIn January 2023, the FDA revised the EUA for Evusheld to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5683","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TIXAGEVIMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TIXAGEVIMAB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Tixagevimab%2Fcilgavimab","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T16:01:11.275668","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:17:17.051787+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"palivizumab","drugSlug":"palivizumab","fdaApproval":"1998-06-19","relationship":"same-class"},{"drugName":"ansuvimab","drugSlug":"ansuvimab","fdaApproval":"2020-12-21","relationship":"same-class"},{"drugName":"casirivimab","drugSlug":"casirivimab","fdaApproval":"2020-11-21","relationship":"same-class"},{"drugName":"imdevimab","drugSlug":"imdevimab","fdaApproval":"2020-11-21","relationship":"same-class"},{"drugName":"nirsevimab","drugSlug":"nirsevimab","fdaApproval":"2023-07-17","relationship":"same-class"}],"genericName":"tixagevimab","indications":{"approved":[{"name":"COVID-19","source":"DrugCentral","snomedId":840539006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"palivizumab","brandName":"palivizumab","genericName":"palivizumab","approvalYear":"1998","relationship":"same-class"},{"drugId":"ansuvimab","brandName":"ansuvimab","genericName":"ansuvimab","approvalYear":"2020","relationship":"same-class"},{"drugId":"casirivimab","brandName":"casirivimab","genericName":"casirivimab","approvalYear":"2020","relationship":"same-class"},{"drugId":"imdevimab","brandName":"imdevimab","genericName":"imdevimab","approvalYear":"2020","relationship":"same-class"},{"drugId":"nirsevimab","brandName":"nirsevimab","genericName":"nirsevimab","approvalYear":"2023","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07473986","phase":"","title":"REAl LIfe\" Observational Study on the Effectiveness of Evusheld Prophylaxis Against SARS-CoV-2 Omicron Variants in Vaccine Non-responder Immunocompromised Patients","status":"COMPLETED","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2022-07-08","conditions":["SARS-CoV-2 Omicron Variants"],"enrollment":88,"completionDate":"2024-12-31"},{"nctId":"NCT05041907","phase":"PHASE2","title":"Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2021-09-30","conditions":["COVID-19"],"enrollment":3800,"completionDate":"2027-01"},{"nctId":"NCT05281601","phase":"PHASE1","title":"AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-03-21","conditions":["SARS-CoV-2"],"enrollment":46,"completionDate":"2024-04-16"},{"nctId":"NCT05648110","phase":"PHASE2,PHASE3","title":"Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-12-16","conditions":["COVID-19, SARS-CoV-2"],"enrollment":3882,"completionDate":"2025-02-11"},{"nctId":"NCT05780437","phase":"PHASE3","title":"AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-02-10","conditions":["COVID-19"],"enrollment":1455,"completionDate":"2023-06-09"},{"nctId":"NCT05712096","phase":"","title":"eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-03-09","conditions":["SARS-CoV-2","COVID-19"],"enrollment":4000,"completionDate":"2023-05-30"},{"nctId":"NCT04625725","phase":"PHASE3","title":"Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-11-21","conditions":["COVID-19"],"enrollment":5197,"completionDate":"2023-12-08"},{"nctId":"NCT05166421","phase":"PHASE1","title":"Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-11-30","conditions":["Corona Virus Disease"],"enrollment":224,"completionDate":"2023-07-19"},{"nctId":"NCT05184062","phase":"PHASE2","title":"A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-12-03","conditions":["Coronavirus Disease 2019 (COVID-19)"],"enrollment":272,"completionDate":"2023-05-06"},{"nctId":"NCT05667116","phase":"","title":"eVusheld Assessment reaL wORld Effectiveness at UPMC","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-01-09","conditions":["SARS-CoV-2, COVID-19"],"enrollment":4232,"completionDate":"2023-07-24"},{"nctId":"NCT05271929","phase":"PHASE3","title":"Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19","status":"TERMINATED","sponsor":"Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen","startDate":"2022-04-01","conditions":["COVID-19"],"enrollment":120,"completionDate":"2024-06-17"},{"nctId":"NCT05375760","phase":"PHASE2","title":"A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2022-06-09","conditions":["Coronavirus Disease 2019 (COVID-19)"],"enrollment":251,"completionDate":"2023-10-04"},{"nctId":"NCT04507256","phase":"PHASE1","title":"AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-08-18","conditions":["COVID-19"],"enrollment":60,"completionDate":"2021-10-19"},{"nctId":"NCT04315948","phase":"PHASE3","title":"Trial of Treatments for COVID-19 in Hospitalized Adults","status":"COMPLETED","sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","startDate":"2020-03-22","conditions":["Corona Virus Infection"],"enrollment":1552,"completionDate":"2023-09-25"},{"nctId":"NCT05569408","phase":"","title":"eVusheld Assessment reaL wORld Effectiveness in DoD Health System","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-08-10","conditions":["COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease"],"enrollment":4724,"completionDate":"2023-12-22"},{"nctId":"NCT05663957","phase":"","title":"eVusheld Assessment reaL wORld Effectiveness in the VA Health System","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-01-04","conditions":["SARS-CoV-2, COVID-19"],"enrollment":5814,"completionDate":"2023-09-01"},{"nctId":"NCT04518410","phase":"PHASE2,PHASE3","title":"ACTIV-2: A Study for Outpatients With COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-19","conditions":["Coronavirus","Covid19"],"enrollment":4044,"completionDate":"2023-06-20"},{"nctId":"NCT05461378","phase":"","title":"PREP (Pre-Exposure Prophylaxis) of COVID-19","status":"COMPLETED","sponsor":"Ghady Haidar","startDate":"2022-07-26","conditions":["Immuno-Deficiency","COVID-19"],"enrollment":138,"completionDate":"2024-01-29"},{"nctId":"NCT06156982","phase":"","title":"An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-12-06","conditions":["COVID-19"],"enrollment":397,"completionDate":"2024-01-09"},{"nctId":"NCT05465876","phase":"PHASE2","title":"Passive Antibodies Against COVID-19 With EVUSHELD in Vaccine Non-responsive CLL","status":"WITHDRAWN","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2023-10","conditions":["Chronic Lymphocytic Leukemia","COVID-19"],"enrollment":0,"completionDate":"2025-10"},{"nctId":"NCT05847140","phase":"","title":"A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ During Pregnancy","status":"WITHDRAWN","sponsor":"AstraZeneca","startDate":"2022-06-27","conditions":["Pregnancy","Pregnant Women","Pregnancy Outcome"],"enrollment":0,"completionDate":"2024-01-31"},{"nctId":"NCT05803395","phase":"","title":"Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.","status":"UNKNOWN","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","startDate":"2023-09-12","conditions":["Chronic Lymphocytic Leukemia","Indolent B-Cell Non-Hodgkin Lymphoma","COVID-19"],"enrollment":954,"completionDate":"2024-09"},{"nctId":"NCT04625972","phase":"PHASE3","title":"Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-12-02","conditions":["COVID-19"],"enrollment":1131,"completionDate":"2022-07-25"},{"nctId":"NCT05321394","phase":"PHASE3","title":"Non-inferiority Trial on Treatments in Early COVID-19","status":"COMPLETED","sponsor":"Azienda Ospedaliera Universitaria Integrata Verona","startDate":"2022-03-07","conditions":["COVID-19"],"enrollment":536,"completionDate":"2023-10-29"},{"nctId":"NCT05438498","phase":"PHASE3","title":"Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2","status":"TERMINATED","sponsor":"MediMergent, LLC","startDate":"2022-06-03","conditions":["SARS-CoV-2 Infection"],"enrollment":550,"completionDate":"2023-06-30"},{"nctId":"NCT04501978","phase":"PHASE3","title":"ACTIV-3: Therapeutics for Inpatients With COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-04","conditions":["Covid19"],"enrollment":2753,"completionDate":"2023-07-14"},{"nctId":"NCT05982704","phase":"PHASE4","title":"Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19","status":"UNKNOWN","sponsor":"City Clinical Hospital No.52 of Moscow Healthcare Department","startDate":"2022-08-18","conditions":["Coronavirus Infections"],"enrollment":82,"completionDate":"2023-11-01"},{"nctId":"NCT04723394","phase":"PHASE3","title":"Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-01-28","conditions":["COVID-19"],"enrollment":910,"completionDate":"2022-10-19"},{"nctId":"NCT05437289","phase":"PHASE1","title":"A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-10-09","conditions":["Coronavirus Disease 2019 (COVID-19)","Healthy Volunteer"],"enrollment":61,"completionDate":"2023-01-16"},{"nctId":"NCT05629923","phase":"","title":"EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS","status":"COMPLETED","sponsor":"University of Rome Tor Vergata","startDate":"2022-02-01","conditions":["COVID-19 Pandemic","Transplant-Related Disorder"],"enrollment":306,"completionDate":"2022-11-30"},{"nctId":"NCT05234398","phase":"","title":"TIXAGEVIMAB/CILGAVIMAB Protection of Covid-19 in Transplanted Patients","status":"WITHDRAWN","sponsor":"Hospices Civils de Lyon","startDate":"2022-02","conditions":["Solid Organ Transplant Recipients"],"enrollment":0,"completionDate":"2023-08"},{"nctId":"NCT05439044","phase":"","title":"A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2020-03-01","conditions":["Immunocompromised Patients"],"enrollment":4000,"completionDate":"2022-12-31"},{"nctId":"NCT04896541","phase":"PHASE1","title":"Phase I Double-blind, Placebo-controlled Study of AZD7442","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-03-16","conditions":["COVID-19"],"enrollment":40,"completionDate":"2022-06-14"}],"_emaApprovals":[{"date":"2022-03-25","status":"Authorised","company":"AstraZeneca AB"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"MMSL":"353927","NDDF":"018902","UNII":"F0LZ415Z3B","VANDF":"4041036","INN_ID":"11776","RXNORM":"2587300","UMLSCUI":"C5432264","chemblId":"CHEMBL4650265","ChEMBL_ID":"CHEMBL4650265","KEGG_DRUG":"D11993","DRUGBANK_ID":"DB16394","IUPHAR_LIGAND_ID":"11330","MESH_SUPPLEMENTAL_RECORD_UI":"C000714167"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"AstraZeneca","relationship":"Original Developer"},{"period":"2022","companyName":"AstraZeneca K.K.","relationship":"PMDA Licensee"}],"publicationCount":361,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J06BD03","allCodes":["J06BD03"]},"biosimilarFilings":[],"originalDeveloper":"AstraZeneca AB","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"AstraZeneca","companyId":"astrazeneca","modality":"Monoclonal antibody","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2022-03-25T00:00:00.000Z","mah":"AstraZeneca AB","brand_name_local":"","application_number":""},{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2022-08-30T00:00:00.000Z","mah":"AstraZeneca K.K.","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":4,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:17:17.051787+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}