{"id":"am-101","safety":{"commonSideEffects":[{"rate":null,"effect":"Ear pain or discomfort"},{"rate":null,"effect":"Temporary hearing changes"},{"rate":null,"effect":"Ear fullness sensation"},{"rate":null,"effect":"Vertigo or dizziness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AM-101 works by modulating glutamatergic neurotransmission in the cochlea and auditory pathways, specifically targeting NMDA receptors involved in tinnitus generation. The drug is administered directly into the middle ear via intratympanic injection, allowing it to reach the inner ear and suppress abnormal neural activity associated with tinnitus perception.","oneSentence":"AM-101 is an intratympanic injection that delivers a small-molecule NMDA receptor antagonist to the inner ear to reduce tinnitus perception.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:28.985Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute noise-induced tinnitus"},{"name":"Sudden sensorineural hearing loss with tinnitus"}]},"trialDetails":[{"nctId":"NCT02040207","phase":"PHASE3","title":"AM-101 in the Treatment of Post-Acute Tinnitus 2","status":"COMPLETED","sponsor":"Auris Medical AG","startDate":"2014-06","conditions":"Tinnitus","enrollment":487},{"nctId":"NCT02040194","phase":"PHASE3","title":"AM-101 in the Treatment of Acute Tinnitus 3","status":"COMPLETED","sponsor":"Auris Medical AG","startDate":"2014-01","conditions":"Tinnitus","enrollment":893},{"nctId":"NCT01803646","phase":"PHASE3","title":"AM-101 in the Treatment of Acute Tinnitus 2","status":"COMPLETED","sponsor":"Auris Medical, Inc.","startDate":"2014-02","conditions":"Tinnitus","enrollment":343},{"nctId":"NCT01934010","phase":"PHASE3","title":"AM-101 in the Treatment of Post-Acute Tinnitus 1","status":"COMPLETED","sponsor":"Auris Medical, Inc.","startDate":"2014-06","conditions":"Tinnitus","enrollment":260},{"nctId":"NCT01270282","phase":"PHASE2","title":"Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus","status":"COMPLETED","sponsor":"Auris Medical, Inc.","startDate":"2011-02","conditions":"Tinnitus","enrollment":82},{"nctId":"NCT00860808","phase":"PHASE2","title":"Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus","status":"COMPLETED","sponsor":"Auris Medical AG","startDate":"2009-03","conditions":"Tinnitus","enrollment":248}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"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":"AM-101","genericName":"AM-101","companyName":"Auris Medical AG","companyId":"auris-medical-ag","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AM-101 is an intratympanic injection that delivers a small-molecule NMDA receptor antagonist to the inner ear to reduce tinnitus perception. Used for Acute noise-induced tinnitus, Sudden sensorineural hearing loss with tinnitus.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}