{"id":"immunotherapy-staloral","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Oral pruritus"},{"rate":"5-15","effect":"Throat irritation"},{"rate":"5-10","effect":"Mouth edema"},{"rate":"5-10","effect":"Ear pruritus"},{"rate":"5-10","effect":"Gastrointestinal symptoms"}]},"_chembl":{"chemblId":"CHEMBL2108717","moleculeType":"Cell"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Staloral works by administering small, increasing doses of allergen extract under the tongue, which promotes a shift from Th2-mediated allergic responses to Th1/Treg-mediated tolerance. This sublingual immunotherapy (SLIT) approach allows for gradual immune system adaptation to the allergen, reducing allergic symptoms and the need for symptomatic medications over time.","oneSentence":"Staloral is a sublingual immunotherapy that desensitizes the immune system to allergens by inducing immune tolerance through repeated exposure to gradually increasing allergen doses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:48:17.016Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis and/or allergic asthma caused by grass pollen allergens"},{"name":"Allergic rhinitis and/or allergic asthma caused by tree pollen allergens"}]},"trialDetails":[{"nctId":"NCT02557269","phase":"PHASE4","title":"4\"S\" - Seasonal Symptoms Suppression Study","status":"UNKNOWN","sponsor":"Association Asthma, Bulgaria","startDate":"2015-05","conditions":"Seasonal Allergic Rhinitis","enrollment":60},{"nctId":"NCT00250263","phase":"PHASE4","title":"A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy","status":"COMPLETED","sponsor":"Bayside Health","startDate":"2005-11","conditions":"Allergic Rhinitis, Asthma","enrollment":30},{"nctId":"NCT01052610","phase":"PHASE4","title":"Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites","status":"UNKNOWN","sponsor":"Medical University of Lodz","startDate":"2010-06","conditions":"Bronchial Asthma, Allergic Rhinitis","enrollment":100},{"nctId":"NCT01785394","phase":"PHASE4","title":"POLlinosis and Exhaled Breath Temperature","status":"UNKNOWN","sponsor":"Prof. Todor Popov","startDate":"2012-02","conditions":"Pollinosis","enrollment":60},{"nctId":"NCT01731249","phase":"PHASE3","title":"Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis","status":"COMPLETED","sponsor":"Stallergenes Greer","startDate":"2010-11","conditions":"Hypersensitivity, Allergic Rhinitis, Allergic Conjunctivitis","enrollment":574},{"nctId":"NCT01605760","phase":"PHASE4","title":"House Dust Mite SLIT in Elderly Patients","status":"COMPLETED","sponsor":"Medical University of Silesia","startDate":"2008-01","conditions":"Allergic Rhinitis","enrollment":111},{"nctId":"NCT00932607","phase":"PHASE2","title":"SUBLIVAC® Birch PROBE Study","status":"COMPLETED","sponsor":"HAL Allergy","startDate":"2009-07","conditions":"Seasonal Rhinitis and/or Rhinoconjunctivitis, Birch Pollen Allergy","enrollment":74},{"nctId":"NCT00660452","phase":"PHASE3","title":"A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites","status":"COMPLETED","sponsor":"Stallergenes Greer","startDate":"2007-10","conditions":"Allergy","enrollment":484},{"nctId":"NCT00698594","phase":"PHASE4","title":"Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis","status":"COMPLETED","sponsor":"Medical University of Lodz","startDate":"2008-09","conditions":"Allergic Rhinitis","enrollment":60},{"nctId":"NCT00518518","phase":"PHASE4","title":"Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen","status":"COMPLETED","sponsor":"Medical University of Lodz","startDate":"2006-03","conditions":"Asthma","enrollment":50},{"nctId":"NCT00172341","phase":"PHASE4","title":"Sublingual Immunotherapy With House Dust Mite Extract in Asthmatic Children","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"","conditions":"Asthma","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"immunotherapy Staloral","genericName":"immunotherapy Staloral","companyName":"Medical University of Silesia","companyId":"medical-university-of-silesia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Staloral is a sublingual immunotherapy that desensitizes the immune system to allergens by inducing immune tolerance through repeated exposure to gradually increasing allergen doses. Used for Allergic rhinitis and/or allergic asthma caused by grass pollen allergens, Allergic rhinitis and/or allergic asthma caused by tree pollen allergens.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}