{"id":"randomisation-to-omalizumab","safety":{"commonSideEffects":[{"rate":"45","effect":"Injection site reaction"},{"rate":"23","effect":"Viral upper respiratory tract infection"},{"rate":"13","effect":"Sinusitis"},{"rate":"12","effect":"Headache"},{"rate":"8","effect":"Arthralgia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By sequestering free IgE, omalizumab reduces the activation of mast cells and basophils, which are key effector cells in allergic and IgE-mediated inflammatory responses. This mechanism reduces the release of inflammatory mediators such as histamine and leukotrienes, thereby suppressing allergic cascade reactions. The drug is effective in conditions driven by IgE-mediated pathways, particularly moderate-to-severe allergic asthma and chronic spontaneous urticaria.","oneSentence":"Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing its interaction with high-affinity IgE receptors on mast cells and basophils.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:58.691Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate-to-severe allergic asthma"},{"name":"Chronic spontaneous urticaria"},{"name":"Nasal polyposis with eosinophilic granulomatosis with polyangiitis (EGPA)"}]},"trialDetails":[{"nctId":"NCT03476109","phase":"PHASE4","title":"Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.","status":"UNKNOWN","sponsor":"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","startDate":"2019-05-10","conditions":"Severe Asthma","enrollment":100}],"_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":["Active-controlled"],"phase":"marketed","status":"active","brandName":"Randomisation to omalizumab","genericName":"Randomisation to omalizumab","companyName":"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","companyId":"cliniques-universitaires-saint-luc-universit-catholique-de-louvain","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing its interaction with high-affinity IgE receptors on mast cells and basophils. Used for Moderate-to-severe allergic asthma, Chronic spontaneous urticaria, Nasal polyposis with eosinophilic granulomatosis with polyangiitis (EGPA).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}