NDAOTICINJECTABLE, SUSPENSION
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
OTIPRIO (ciprofloxacin) by Hikma is [see ] . First approved in 2015.
Drug data last refreshed 48m ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTIPRIO is a ciprofloxacin otic suspension approved in 2015 for treating ear infections via direct otic administration. The formulation combines ciprofloxacin (fluoroquinolone antibiotic) with dexamethasone (corticosteroid) to provide dual antimicrobial and anti-inflammatory action. It suppresses inflammation by inhibiting cytokines, reducing edema, fibrin deposition, and inflammatory cell migration.
Peak12.2 years to LOE
Product is in peak commercial phase with Hikma as sponsor; team focus is on maximizing market penetration and defending market position through 2038.
Mechanism of Action
[see ] . Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Started Apr 2025
2,627 enrolled
Neisseria Gonorrheae Infection
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
Started Apr 2023
64 enrolled
Healthy Subjects
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
Started Jun 2022
313 enrolled
Acute Lymphoblastic Leukaemia - Category
A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)
Started Nov 2020
600 enrolled
Acute Otitis Externa
Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
Started Nov 2019
85 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.