{"id":"otosynalar","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation or sensitization"},{"rate":null,"effect":"Allergic contact dermatitis"},{"rate":null,"effect":"Secondary infection"}]},"_chembl":{"chemblId":"CHEMBL989","moleculeType":"Small molecule","molecularWeight":"452.49"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formulation combines a corticosteroid (typically neomycin and dexamethasone or similar agents) to suppress inflammatory response and reduce swelling in otitis externa, paired with an antibiotic component to address bacterial infection. This dual action addresses both the infectious and inflammatory components of ear canal disease.","oneSentence":"Otosynalar is a topical corticosteroid-antibiotic combination that reduces inflammation and treats bacterial infection in the ear canal.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:25:02.780Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute otitis externa (swimmer's ear)"},{"name":"Bacterial infection of the external ear canal with inflammation"}]},"trialDetails":[{"nctId":"NCT00967317","phase":"PHASE3","title":"Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.","status":"UNKNOWN","sponsor":"Laboratorios Osorio de Moraes Ltda.","startDate":"2009-12","conditions":"Otitis, Efficacy, Tolerability","enrollment":188}],"_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":"phase_3","status":"active","brandName":"Otosynalar®","genericName":"Otosynalar®","companyName":"Laboratorios Osorio de Moraes Ltda.","companyId":"laboratorios-osorio-de-moraes-ltda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Otosynalar is a small molecule that acts as a glucocorticoid receptor agonist. It is used to evaluate the efficacy and safety in the symptomatic control of otalgia in patients with otitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}