{"id":"eu-approved-xolair","safety":{"commonSideEffects":[{"rate":"10–15","effect":"Injection site reactions"},{"rate":"8–12","effect":"Headache"},{"rate":"5–10","effect":"Upper respiratory tract infection"},{"rate":"5–8","effect":"Arthralgia"},{"rate":"3–7","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL5857501","moleculeType":null,"molecularWeight":"542.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By sequestering circulating IgE, Xolair reduces the amount of IgE available to cross-link FcεRI receptors on mast cells and basophils. This prevents degranulation and release of inflammatory mediators (histamine, tryptase, leukotrienes) that drive allergic symptoms. The reduction in IgE-mediated activation leads to decreased allergic inflammation across multiple tissues.","oneSentence":"Xolair is a monoclonal antibody that binds to immunoglobulin E (IgE) and prevents its interaction with high-affinity IgE receptors on mast cells and basophils, thereby reducing allergic cascade activation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:47.967Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe allergic asthma"},{"name":"Chronic idiopathic urticaria"},{"name":"Allergic rhinitis (in some markets)"}]},"trialDetails":[{"nctId":"NCT04426890","phase":"PHASE3","title":"To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-12-09","conditions":"Chronic Spontaneous Urticaria","enrollment":634},{"nctId":"NCT05053334","phase":"PHASE1","title":"Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair","status":"COMPLETED","sponsor":"Syneos Health","startDate":"2022-02-16","conditions":"Healthy Volunteers","enrollment":165},{"nctId":"NCT05413161","phase":"PHASE1","title":"To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects","status":"COMPLETED","sponsor":"Kashiv BioSciences, LLC","startDate":"2022-07-07","conditions":"Healthy","enrollment":306},{"nctId":"NCT04018313","phase":"PHASE1","title":"To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-05-28","conditions":"Healthy","enrollment":176}],"_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":["Omalizumab"],"phase":"phase_3","status":"active","brandName":"EU-approved Xolair","genericName":"EU-approved Xolair","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"Xolair is a monoclonal antibody that binds to immunoglobulin E (IgE) and prevents its interaction with high-affinity IgE receptors on mast cells and basophils, thereby reducing allergic cascade activation. Used for Moderate to severe allergic asthma, Chronic idiopathic urticaria, Allergic rhinitis (in some markets).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}