{"id":"oto-201-ciprofloxacin","safety":{"commonSideEffects":[{"rate":null,"effect":"Ear discomfort or pain"},{"rate":null,"effect":"Ear drainage"},{"rate":null,"effect":"Otorrhea"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":{"chemblId":"CHEMBL8","moleculeType":"Small molecule","molecularWeight":"331.35"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ciprofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV enzymes, which are essential for bacterial DNA replication and transcription. The sustained-release formulation of OTO-201 allows for prolonged local delivery of the antibiotic to the middle ear space, maintaining therapeutic concentrations over an extended period to treat middle ear infections.","oneSentence":"OTO-201 is a sustained-release formulation of ciprofloxacin, a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV to kill bacteria in the middle ear.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:54.476Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute otitis media with tympanostomy tubes (AOMT)"},{"name":"Chronic suppurative otitis media (CSOM)"}]},"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":"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":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["OTIPRIO"],"phase":"phase_3","status":"active","brandName":"OTO-201 (ciprofloxacin)","genericName":"OTO-201 (ciprofloxacin)","companyName":"Otonomy, Inc.","companyId":"otonomy-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OTO-201 is a sustained-release formulation of ciprofloxacin, a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV to kill bacteria in the middle ear. Used for Acute otitis media with tympanostomy tubes (AOMT), Chronic suppurative otitis media (CSOM).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}