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Levofloxacin only
Levofloxacin only is a Fluoroquinolone antibiotic Small molecule drug developed by Innocoll. It is currently in Phase 2 development for Community-acquired pneumonia, Skin and skin structure infections, Complicated urinary tract infections. Also known as: Tavanic, Levaquin.
Inhibits DNA gyrase and topoisomerase IV
Inhibits DNA gyrase and topoisomerase IV Used for Community-acquired pneumonia, Skin and skin structure infections, Complicated urinary tract infections.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Levofloxacin only |
|---|---|
| Also known as | Tavanic, Levaquin |
| Sponsor | Innocoll |
| Drug class | Fluoroquinolone antibiotic |
| Target | DNA gyrase and topoisomerase IV |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Levofloxacin is a fluoroquinolone antibiotic that works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes critical for bacterial DNA replication and transcription.
Approved indications
- Community-acquired pneumonia
- Skin and skin structure infections
- Complicated urinary tract infections
Common side effects
- Nausea
- Diarrhea
- Headache
Key clinical trials
- Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- A Platform Trial for Gram Negative Bloodstream Infections (NA)
- Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women (PHASE1)
- A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia (PHASE1)
- Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath (NA)
- Preoperative Prophylactic Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Postpercutaneous Nephrolithotomy Infectious Complications and Sepsis. (NA)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
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:
- Levofloxacin only CI brief — competitive landscape report
- Levofloxacin only updates RSS · CI watch RSS
- Innocoll portfolio CI
Frequently asked questions about Levofloxacin only
What is Levofloxacin only?
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Is Levofloxacin only also known as anything else?
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Related
- Drug class: All Fluoroquinolone antibiotic drugs
- Target: All drugs targeting DNA gyrase and topoisomerase IV
- Manufacturer: Innocoll — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Skin and skin structure infections
- Indication: Drugs for Complicated urinary tract infections
- Also known as: Tavanic, Levaquin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing