{"id":"biotene-mouth-care","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation or sensitivity"},{"rate":null,"effect":"Taste alteration"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Biotene is a saliva substitute and oral moisturizer system designed for patients with xerostomia (dry mouth). It contains water, sorbitol, sodium carboxymethylcellulose, and other humectants that coat oral tissues and provide lubrication. The product may also contain enzymes and antimicrobial components to help restore some protective functions of natural saliva.","oneSentence":"Biotene provides symptomatic relief of dry mouth by delivering moisturizing and lubricating agents that mimic natural saliva.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:21:11.980Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Xerostomia (dry mouth) symptomatic relief"},{"name":"Dry mouth associated with cancer therapy, Sjögren's syndrome, or other causes"}]},"trialDetails":[{"nctId":"NCT03682081","phase":"NA","title":"Interventions for Patients With Alzheimer's Disease and Dysphagia","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2020-09-25","conditions":"Dementia, Dysphagia, Alzheimer Disease","enrollment":76},{"nctId":"NCT04289051","phase":"NA","title":"Clinical Evaluation of Oral Rinse for Xerostomia","status":"COMPLETED","sponsor":"Sunstar Americas","startDate":"2020-08-19","conditions":"Xerostomia","enrollment":39},{"nctId":"NCT01314742","phase":"EARLY_PHASE1","title":"Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2010-05","conditions":"Ventilator-associated Pneumonia","enrollment":41},{"nctId":"NCT02522936","phase":"PHASE4","title":"Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use","status":"WITHDRAWN","sponsor":"University of Southern California","startDate":"2018-08-01","conditions":"Overactive Bladder, Xerostomia, Compliance","enrollment":""},{"nctId":"NCT00138827","phase":"PHASE4","title":"Mouth Care Regimes During Radiotherapy","status":"COMPLETED","sponsor":"St George Hospital, Australia","startDate":"1999-11","conditions":"Head and Neck Neoplasms","enrollment":50}],"_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":"marketed","status":"active","brandName":"Biotene (mouth care)","genericName":"Biotene (mouth care)","companyName":"St George Hospital, Australia","companyId":"st-george-hospital-australia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Biotene provides symptomatic relief of dry mouth by delivering moisturizing and lubricating agents that mimic natural saliva. Used for Xerostomia (dry mouth) symptomatic relief, Dry mouth associated with cancer therapy, Sjögren's syndrome, or other causes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}