{"id":"staloral-300","safety":{"commonSideEffects":[{"rate":"30-50","effect":"Oral pruritus"},{"rate":"20-40","effect":"Throat irritation"},{"rate":"10-30","effect":"Ear pruritus"},{"rate":"5-15","effect":"Mouth edema"},{"rate":"5-10","effect":"Gastrointestinal symptoms"}]},"_chembl":{"chemblId":"CHEMBL3654060","moleculeType":"Small molecule","molecularWeight":"910.54"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Staloral is a sublingual immunotherapy (SLIT) tablet containing standardized grass pollen allergen extract. It works by gradually exposing the immune system to increasing doses of the allergen, promoting immune tolerance through induction of regulatory T cells and shift toward Th1/Treg responses. This reduces allergic symptoms and the need for symptomatic medications in patients with grass pollen-induced allergic rhinitis and asthma.","oneSentence":"Staloral 300 is an allergen immunotherapy that desensitizes the immune system to grass pollen allergens through sublingual administration.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:38:00.261Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Grass pollen-induced allergic rhinitis"},{"name":"Grass pollen-induced allergic asthma"}]},"trialDetails":[{"nctId":"NCT05668390","phase":"PHASE3","title":"Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma","status":"COMPLETED","sponsor":"Stallergenes Greer","startDate":"2023-09-20","conditions":"Allergic Rhinoconjunctivitis, Birch Pollen Allergy","enrollment":553},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"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":"Staloral 300","genericName":"Staloral 300","companyName":"Medical University of Lodz","companyId":"medical-university-of-lodz","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Staloral 300 is an allergen immunotherapy that desensitizes the immune system to grass pollen allergens through sublingual administration. Used for Grass pollen-induced allergic rhinitis, Grass pollen-induced allergic asthma.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}