{"id":"omalizumab","brandName":"Xolair","genericName":"omalizumab","companyId":"roche","companyName":"Roche","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":1,"mechanism":{"target":"Ig epsilon chain C region","drugClass":"Anti-IgE [EPC]","_target_confidence":0.5},"administration":{"route":"Subcutaneous"},"safety":{"boxedWarnings":["WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. Initiate XOLAIR therapy in a healthcare setting, closely observe patients for an appropriate period of time after XOLAIR administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis. ( 2.6 , 5.1 , 6.1 , 6.2 )"],"safetySignals":[{"date":"","signal":"ASTHMA","source":"FDA FAERS","actionTaken":"11601 reports"},{"date":"","signal":"URTICARIA","source":"FDA FAERS","actionTaken":"10326 reports"},{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"10204 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"9929 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"9877 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"7779 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"6767 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"5943 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"5824 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"5429 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Injection site reaction","drugRate":"45%","severity":"common","organSystem":""},{"effect":"Viral infections","drugRate":"23%","severity":"common","organSystem":""},{"effect":"Upper respiratory tract infection","drugRate":"20%","severity":"common","organSystem":""},{"effect":"Sinusitis","drugRate":"16%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Pharyngitis","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Severe injection site reactions","drugRate":"12%","severity":"common","organSystem":""}],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Anaphylaxis","drugRate":"0.2%","severity":"serious"}]},"trials":["NCT06438757","NCT06437171","NCT00226200","NCT00787917","NCT01155700","NCT04045301","NCT00180011","NCT04665141","NCT04998604","NCT05424523","NCT01040598","NCT04976192","NCT01007149","NCT05405478","NCT05157087","NCT01287117","NCT00219323","NCT00949078","NCT05972213","NCT00555971","NCT01713725","NCT04361812","NCT04489121","NCT00382148","NCT00046748","NCT00968110","NCT05564611","NCT02166151","NCT00691873","NCT04018313","NCT06316414","NCT02570984","NCT01723072","NCT00401596","NCT00639691","NCT02161562","NCT01292473","NCT01701583","NCT00189228","NCT04607629","NCT01264939","NCT03580369","NCT00670930","NCT01781637","NCT03361111","NCT01584687","NCT00117611","NCT02300701","NCT02402231","NCT04601389"],"indications":{"approved":[{"name":"Asthma","diseaseId":"asthma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic idiopathic urticaria","diseaseId":"chronic-idiopathic-urticaria","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Seasonal allergic rhinitis","diseaseId":"seasonal-allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"commercial":{"revenueYear":2024,"annualRevenue":3200,"revenueSource":"Verified: Roche AR","revenueCurrency":"USD","revenueConfidence":"verified"},"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT06438757","phase":"Phase 2","title":"Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Jemincare","isPivotal":false,"enrollment":69,"indication":"Allergic Asthma","completionDate":"2025-10-31"},{"nctId":"NCT06437171","phase":"Phase 4","title":"The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies","status":"ACTIVE_NOT_RECRUITING","sponsor":"AAADRS Clinical Research Center","isPivotal":false,"enrollment":20,"indication":"Food Allergy","completionDate":"2026-12"},{"nctId":"NCT00226200","phase":"NA","title":"Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab","status":"TERMINATED","sponsor":"University of Mississippi Medical Center","isPivotal":false,"enrollment":80,"indication":"Asthma","completionDate":"2007-10"},{"nctId":"NCT00787917","phase":"Phase 4","title":"An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABP","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","isPivotal":false,"enrollment":14,"indication":"Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis","completionDate":"2010-07"},{"nctId":"NCT01155700","phase":"Phase 3","title":"A 24 Week, Open Label, Multi-center Evaluation of Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 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