{"id":"sublivac-fix-birch","safety":{"commonSideEffects":[{"rate":null,"effect":"Oral pruritus (itching in mouth)"},{"rate":null,"effect":"Throat irritation"},{"rate":null,"effect":"Edema of mouth/lips"},{"rate":null,"effect":"Local allergic reactions at administration site"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is an allergen immunotherapy product administered sublingually (under the tongue) containing birch pollen extract. It works by inducing immune tolerance to birch allergens through repeated low-dose exposure, shifting the immune response from allergic (Th2-mediated) to tolerant (Treg-mediated), thereby reducing allergic symptoms upon natural exposure to birch pollen.","oneSentence":"SUBLIVAC FIX Birch is a sublingual immunotherapy that desensitizes the immune system to birch pollen allergens through gradual exposure under the tongue.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:36:41.232Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Birch pollen-induced allergic rhinitis and/or allergic asthma"}]},"trialDetails":[{"nctId":"NCT02231307","phase":"PHASE3","title":"SUBLIVAC FIX Birch Phase III Short-term Efficacy","status":"COMPLETED","sponsor":"HAL Allergy","startDate":"2014-09","conditions":"Birch Pollen Induced Rhinitis/Rhinoconjunctivitis","enrollment":406},{"nctId":"NCT01639768","phase":"PHASE2","title":"SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding","status":"COMPLETED","sponsor":"HAL Allergy","startDate":"2012-07","conditions":"Allergic Rhinitis, Allergic Rhinoconjunctivitis","enrollment":270}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"SUBLIVAC FIX Birch","genericName":"SUBLIVAC FIX Birch","companyName":"HAL Allergy","companyId":"hal-allergy","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SUBLIVAC FIX Birch is a small molecule intervention used to study the treatment of conditions such as Allergic Rhinitis, Allergic Rhinoconjunctivitis, and Birch Pollen Induced Rhinitis/Rhinoconjunctivitis. The mechanism of action of SUBLIVAC FIX Birch is currently unknown.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}