{"id":"xolair-prefilled-syringe","safety":{"commonSideEffects":[{"rate":"~45%","effect":"Injection site reaction"},{"rate":"~12%","effect":"Headache"},{"rate":"~11%","effect":"Upper respiratory tract infection"},{"rate":"~8%","effect":"Arthralgia"},{"rate":"~6%","effect":"Fatigue"},{"rate":"<0.1%","effect":"Anaphylaxis"}]},"_chembl":{"chemblId":"CHEMBL1414","moleculeType":"Small molecule","molecularWeight":"198.17"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"By sequestering free IgE, omalizumab 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 prefilled syringe formulation provides a convenient subcutaneous delivery method for this anti-IgE therapy.","oneSentence":"Xolair (omalizumab) is a monoclonal antibody that binds to circulating 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":"2026-03-28T01:41:07.782Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe allergic asthma"},{"name":"Chronic idiopathic urticaria"},{"name":"Allergic rhinitis (in some formulations)"}]},"trialDetails":[{"nctId":"NCT04976192","phase":"PHASE3","title":"Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2021-08-30","conditions":"Chronic Urticaria","enrollment":608},{"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":"NCT05332067","phase":"PHASE2","title":"Omalizumab Before Onset of Exacerbations","status":"RECRUITING","sponsor":"Children's National Research Institute","startDate":"2022-05-01","conditions":"Asthma in Children, Atopy, Viral Upper Respiratory Infection","enrollment":300},{"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":"NCT05774639","phase":"PHASE3","title":"Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria","status":"COMPLETED","sponsor":"Kashiv BioSciences, LLC","startDate":"2023-08-15","conditions":"Chronic Idiopathic Urticaria","enrollment":600},{"nctId":"NCT05564221","phase":"PHASE1","title":"A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases","status":"COMPLETED","sponsor":"Yuhan Corporation","startDate":"2022-11-01","conditions":"Atopic Healthy Subjects, Adult Subjects With Allergic Diseases","enrollment":46},{"nctId":"NCT05960708","phase":"PHASE1","title":"A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases","status":"COMPLETED","sponsor":"Yuhan Corporation","startDate":"2023-08-23","conditions":"Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria","enrollment":30},{"nctId":"NCT03964051","phase":"PHASE4","title":"Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).","status":"TERMINATED","sponsor":"Carsten Bindslev-Jensen","startDate":"2019-07-01","conditions":"Food Allergy","enrollment":7}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"Xolair Prefilled Syringe","genericName":"Xolair Prefilled Syringe","companyName":"Kashiv BioSciences, LLC","companyId":"kashiv-biosciences-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Xolair (omalizumab) is a monoclonal antibody that binds to circulating 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 formulations).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}