{"id":"recombinant-birch-pollen","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (erythema, swelling, pruritus)"},{"rate":null,"effect":"Systemic allergic reactions"},{"rate":null,"effect":"Oral allergy syndrome"},{"rate":null,"effect":"Rhinitis symptoms"}]},"_chembl":{"chemblId":"CHEMBL4650246","moleculeType":"Small molecule"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This recombinant allergen immunotherapy product contains engineered birch pollen proteins designed to induce immune tolerance. By administering gradually increasing doses of the recombinant allergen, the therapy shifts the immune response from IgE-mediated (allergic) to regulatory T cell-mediated tolerance, thereby reducing symptoms upon natural birch pollen exposure.","oneSentence":"Recombinant birch pollen allergen extract desensitizes the immune system to birch pollen through repeated controlled exposure, reducing allergic responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:31:26.301Z","_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":"NCT02098551","phase":"","title":"Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments","status":"COMPLETED","sponsor":"Stefan Woehrl","startDate":"2011-02","conditions":"Atopic Dermatitis","enrollment":30},{"nctId":"NCT01490411","phase":"PHASE2","title":"Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis","status":"COMPLETED","sponsor":"Allergopharma GmbH & Co. KG","startDate":"2010-10","conditions":"Allergic Rhinoconjunctivitis","enrollment":37},{"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":"NCT00396149","phase":"PHASE1","title":"Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1","status":"COMPLETED","sponsor":"Stallergenes Greer","startDate":"2006-11","conditions":"Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal","enrollment":57},{"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":"NCT00889460","phase":"PHASE1","title":"Safety and Tolerability Study of rBet v1 SLIT Tablets","status":"COMPLETED","sponsor":"Stallergenes Greer","startDate":"2007-11","conditions":"Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal","enrollment":55},{"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":34,"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","genericName":"Recombinant birch pollen","companyName":"Allergopharma GmbH & Co. KG","companyId":"allergopharma-gmbh-co-kg","modality":"Biologic","firstApprovalDate":"","aiSummary":"Recombinant birch pollen is being studied as a potential treatment for various allergic conditions, including seasonal allergic rhinitis and birch pollen-related rhinoconjunctivitis. The recombinant birch pollen, known as GNR-127, is administered in different doses (20 mcg, 40 mcg, and 80 mcg) to evaluate its efficacy, safety, and immunogenicity.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}