{"id":"non-sedating-h1-antihistamine","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Pharyngitis"},{"rate":null,"effect":"Somnolence (minimal)"},{"rate":null,"effect":"Dry mouth"}]},"_chembl":{"chemblId":"CHEMBL1813863","moleculeType":"Small molecule","molecularWeight":"632.75"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Non-sedating H1-antihistamines are second-generation antihistamines that competitively antagonize H1 receptors, preventing histamine binding and subsequent allergic cascade activation. Unlike first-generation antihistamines, they are highly selective for peripheral H1 receptors and have poor CNS penetration due to their larger molecular size and/or substrate for efflux transporters, thereby avoiding sedation while maintaining efficacy in allergic conditions.","oneSentence":"Selectively blocks H1 histamine receptors on mast cells and basophils without crossing the blood-brain barrier, preventing histamine-mediated allergic responses without causing sedation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:27.768Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis"},{"name":"Chronic urticaria"},{"name":"Allergic conjunctivitis"}]},"trialDetails":[{"nctId":"NCT04568902","phase":"PHASE1","title":"Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer","status":"COMPLETED","sponsor":"Eisai Co., Ltd.","startDate":"2020-09-30","conditions":"Breast Neoplasms","enrollment":33},{"nctId":"NCT04681729","phase":"PHASE3","title":"Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2020-12-10","conditions":"Cold Urticaria","enrollment":82},{"nctId":"NCT04180488","phase":"PHASE3","title":"Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2019-12-11","conditions":"Chronic Spontaneous Urticaria","enrollment":397},{"nctId":"NCT01918033","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2013-08-20","conditions":"Perennial Allergic Rhinitis","enrollment":608},{"nctId":"NCT01916967","phase":"PHASE3","title":"An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2013-08-27","conditions":"Urticaria","enrollment":239}],"_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":"phase_3","status":"active","brandName":"Non sedating H1-antihistamine","genericName":"Non sedating H1-antihistamine","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Selectively blocks H1 histamine receptors on mast cells and basophils without crossing the blood-brain barrier, preventing histamine-mediated allergic responses without causing sedation. Used for Allergic rhinitis, Chronic urticaria, Allergic conjunctivitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}