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Xtoro (FINAFLOXACIN)
Xtoro (generic name: FINAFLOXACIN) is a Quinolone Antimicrobial Small molecule drug developed by Fonseca Biosciences. It is currently FDA-approved (first approved 2014) for Acute otitis externa.
Xtoro (Finafloxacin) is a quinolone antimicrobial small molecule developed by Alcon Res Ltd and currently owned by Fonseca Biosciences. It was FDA-approved in 2014 for the treatment of acute otitis externa. Xtoro works by inhibiting bacterial DNA replication, ultimately leading to bacterial cell death. As of now, it remains a patented product with no generic manufacturers. Key safety considerations include its potential to cause gastrointestinal side effects and photosensitivity.
At a glance
| Generic name | FINAFLOXACIN |
|---|---|
| Sponsor | Fonseca Biosciences |
| Drug class | Quinolone Antimicrobial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2014 |
Approved indications
- Acute otitis externa
Common side effects
Key clinical trials
- Effect of Age and Gender on the PK and Tolerability of Finafloxacin (PHASE1)
- Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis (PHASE2)
- Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin (PHASE1)
- Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects (PHASE1)
- Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients (PHASE2)
- 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) (PHASE2)
- First Time in Man Study of Finafloxacin Hydrochloride (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xtoro CI brief — competitive landscape report
- Xtoro updates RSS · CI watch RSS
- Fonseca Biosciences portfolio CI
Frequently asked questions about Xtoro
What is Xtoro?
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Who makes Xtoro?
What is the generic name of Xtoro?
What drug class is Xtoro in?
When was Xtoro approved?
What development phase is Xtoro in?
Related
- Drug class: All Quinolone Antimicrobial drugs
- Manufacturer: Fonseca Biosciences — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute otitis externa
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing