XTORO
PeakSMfinafloxacin
NDAOTICSUSPENSION/DROPSPriority Review
Approved
Dec 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XTORO (finafloxacin) is a topical fluoroquinolone antibiotic delivered as an otic suspension for ear infections. It is indicated for bacterial otitis media and other ear infections caused by susceptible pathogens. The drug works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication in gram-positive and gram-negative organisms.
Peak7.4 years to LOE
Product is at peak commercial maturity in the otic antibiotic market; brand team likely maintains steady staffing to defend market position against generic and newer topical competitors.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
Started Dec 2012
225 enrolled
Urinary Tract InfectionsAcute Pyelonephritis
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
Started Jan 2012
18 enrolled
Safety and Tolerability
Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
Started Sep 2010
58 enrolled
Healthy
Effect of Age and Gender on the PK and Tolerability of Finafloxacin
Started Feb 2010
40 enrolled
Pharmacokinetic and Tolerability of Finafloxacin
Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)
Started Oct 2008
36 enrolled
Urinary Tract Infections
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.