{"id":"oto-201","safety":{"commonSideEffects":[{"rate":null,"effect":"Ear pain or discomfort"},{"rate":null,"effect":"Otorrhea (ear drainage)"},{"rate":null,"effect":"Conductive hearing loss"},{"rate":null,"effect":"Tympanic membrane perforation"}]},"_chembl":{"chemblId":"CHEMBL3663495","moleculeType":"Small molecule","molecularWeight":"404.48"},"_fixedAt":"2026-03-30T18:34:29.082591","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OTO-201 consists of dexamethasone suspended in a thermosensitive hydrogel that is injected into the middle ear space, where it provides prolonged local anti-inflammatory effects. The formulation allows for sustained drug release over weeks, reducing the need for systemic corticosteroids or repeated dosing. This localized delivery approach minimizes systemic exposure while targeting the site of inflammation in otitis media with effusion.","oneSentence":"OTO-201 is a sustained-release corticosteroid formulation designed to deliver dexamethasone directly into the middle ear to reduce inflammation and fluid accumulation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:55.857Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Otitis media with effusion in pediatric patients"}]},"_fixedFields":["pubmed(8)"],"trialDetails":[{"nctId":"NCT02511561","phase":"PHASE2","title":"OTO-201 for the Treatment of Otitis Externa","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2015-07","conditions":"Otitis Externa","enrollment":75},{"nctId":"NCT02801370","phase":"PHASE3","title":"Phase 3 Study of OTO-201 in Acute Otitis Externa","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2016-06","conditions":"Acute Otitis Externa, Swimmer's Ear","enrollment":262},{"nctId":"NCT02600559","phase":"PHASE3","title":"Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2015-10","conditions":"Otitis Media","enrollment":501},{"nctId":"NCT02719158","phase":"PHASE2","title":"Dose Ranging Study of OTO-201 in AOMT","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2016-02","conditions":"Acute Otitis Media, AOMT","enrollment":95},{"nctId":"NCT02408796","phase":"PHASE2","title":"Open-Label Study of OTO-201 for Treatment of AOMT","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2015-03","conditions":"Acute Otitis Media, AOMT","enrollment":39},{"nctId":"NCT02350998","phase":"PHASE3","title":"Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2015-01","conditions":"Bilateral Middle Ear Effusion","enrollment":33},{"nctId":"NCT01949155","phase":"PHASE3","title":"OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2013-11","conditions":"Otitis Media With Effusion","enrollment":266},{"nctId":"NCT01949142","phase":"PHASE3","title":"OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2013-11","conditions":"Otitis Media With Effusion","enrollment":266},{"nctId":"NCT01755286","phase":"PHASE1","title":"OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement","status":"COMPLETED","sponsor":"Otonomy, Inc.","startDate":"2012-12","conditions":"Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement","enrollment":83}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"recentPublications":[{"date":"2019 Jun","pmid":"30829050","title":"OTO-201 for the Treatment of Acute Otitis Externa: Results from a Phase 3 Randomized Clinical Study.","journal":"The Annals of otology, rhinology, and laryngology"},{"date":"2018 Oct","pmid":"30084766","title":"Microbial otitis media: recent advancements in treatment, current challenges and opportunities.","journal":"Journal of medical microbiology"},{"date":"2018 Jul-Aug","pmid":"29631747","title":"Tube patency: Is there a difference following otic drop administration?","journal":"American journal of otolaryngology"},{"date":"2018 Mar-Apr","pmid":"29395279","title":"Safety and efficacy of intratympanic ciprofloxacin otic suspension post-tubes in a real-world pediatric population.","journal":"American journal of otolaryngology"},{"date":"2016 Aug","pmid":"27188702","title":"Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes.","journal":"Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ciprofloxacin"],"phase":"phase_3","status":"active","brandName":"OTO-201","genericName":"OTO-201","companyName":"Otonomy, Inc.","companyId":"otonomy-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OTO-201 is a sustained-release corticosteroid formulation designed to deliver dexamethasone directly into the middle ear to reduce inflammation and fluid accumulation. Used for Otitis media with effusion in pediatric patients.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}