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OTO-201 (ciprofloxacin)
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.
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).
At a glance
| Generic name | OTO-201 (ciprofloxacin) |
|---|---|
| Also known as | OTIPRIO |
| Sponsor | Otonomy, Inc. |
| Drug class | Fluoroquinolone antibiotic |
| Target | Bacterial DNA gyrase and topoisomerase IV |
| Modality | Small molecule |
| Therapeutic area | Otology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Acute otitis media with tympanostomy tubes (AOMT)
- Chronic suppurative otitis media (CSOM)
Common side effects
- Ear discomfort or pain
- Ear drainage
- Otorrhea
- Hypersensitivity reactions
Key clinical trials
- OTO-201 for the Treatment of Otitis Externa (PHASE2)
- Phase 3 Study of OTO-201 in Acute Otitis Externa (PHASE3)
- Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes (PHASE3)
- Dose Ranging Study of OTO-201 in AOMT (PHASE2)
- OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement (PHASE3)
- OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement (PHASE3)
- OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OTO-201 (ciprofloxacin) CI brief — competitive landscape report
- OTO-201 (ciprofloxacin) updates RSS · CI watch RSS
- Otonomy, Inc. portfolio CI