{"id":"recombinant-birch-pollen-allergen","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (itching, swelling, erythema)"},{"rate":null,"effect":"Oral allergy syndrome or local oral/throat symptoms"},{"rate":null,"effect":"Systemic allergic reactions"},{"rate":null,"effect":"Rhinitis or asthma exacerbation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"This recombinant allergen extract contains the major birch pollen proteins that trigger allergic reactions. When administered in gradually increasing doses, it promotes immune tolerance by shifting the immune response from IgE-mediated (allergic) to IgG-mediated (protective) antibodies and inducing regulatory T cells. This reduces allergic symptoms upon natural exposure to birch pollen.","oneSentence":"Recombinant birch pollen allergen is used in allergen immunotherapy to desensitize the immune system to birch pollen by inducing tolerance through repeated controlled exposure to the allergen.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:31:27.206Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Birch pollen-induced allergic rhinitis and/or allergic asthma"}]},"trialDetails":[{"nctId":"NCT07155499","phase":"PHASE1, PHASE2","title":"A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis.","status":"ACTIVE_NOT_RECRUITING","sponsor":"AO GENERIUM","startDate":"2024-10-07","conditions":"Rhinitis, Allergic, Seasonal","enrollment":150},{"nctId":"NCT01449786","phase":"PHASE2","title":"Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2012-03-14","conditions":"Birch Pollen Related Apple Allergy, Birch Pollen Allergy","enrollment":60},{"nctId":"NCT00841516","phase":"PHASE2","title":"Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative","status":"COMPLETED","sponsor":"Allergopharma GmbH & Co. KG","startDate":"2007-12","conditions":"Allergic Rhinoconjunctivitis","enrollment":14},{"nctId":"NCT00554983","phase":"PHASE3","title":"Efficacy and Safety From a Recombinant Folding Variant of Bet v 1","status":"COMPLETED","sponsor":"Allergopharma GmbH & Co. KG","startDate":"2007-09","conditions":"Allergy","enrollment":255},{"nctId":"NCT00309062","phase":"PHASE3","title":"Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis","status":"COMPLETED","sponsor":"Allergopharma GmbH & Co. KG","startDate":"2003-12","conditions":"Birch Pollen Allergy","enrollment":""},{"nctId":"NCT00266526","phase":"PHASE2","title":"Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV","status":"COMPLETED","sponsor":"Allergopharma GmbH & Co. KG","startDate":"2003-07","conditions":"Birch Pollen Allergy","enrollment":""},{"nctId":"NCT00410930","phase":"PHASE2","title":"Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients","status":"TERMINATED","sponsor":"Stallergenes Greer","startDate":"2002-11","conditions":"Allergy","enrollment":160}],"_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":[],"phase":"phase_3","status":"active","brandName":"recombinant birch pollen allergen","genericName":"recombinant birch pollen allergen","companyName":"Allergopharma GmbH & Co. KG","companyId":"allergopharma-gmbh-co-kg","modality":"Biologic","firstApprovalDate":"","aiSummary":"Recombinant birch pollen allergen is used in allergen immunotherapy to desensitize the immune system to birch pollen by inducing tolerance through repeated controlled exposure to the allergen. Used for Birch pollen-induced allergic rhinitis and/or allergic asthma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}