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Levofloxacin oral tablets
Levofloxacin oral tablets is a Fluoroquinolone antibiotic Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Community-acquired pneumonia, Acute bacterial sinusitis, Acute bacterial exacerbation of chronic bronchitis.
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription in susceptible bacteria.
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription in susceptible bacteria. Used for Community-acquired pneumonia, Acute bacterial sinusitis, Acute bacterial exacerbation of chronic bronchitis.
At a glance
| Generic name | Levofloxacin oral tablets |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Fluoroquinolone antibiotic |
| Target | DNA gyrase, Topoisomerase IV |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
As a fluoroquinolone antibiotic, levofloxacin works by binding to and inhibiting bacterial DNA gyrase (in gram-negative bacteria) and topoisomerase IV (in gram-positive bacteria), enzymes essential for DNA unwinding and replication. This dual inhibition leads to rapid bactericidal activity against a broad spectrum of gram-positive and gram-negative organisms, as well as atypical pathogens.
Approved indications
- Community-acquired pneumonia
- Acute bacterial sinusitis
- Acute bacterial exacerbation of chronic bronchitis
- Uncomplicated skin and skin structure infections
- Complicated urinary tract infections
- Acute pyelonephritis
- Inhalational anthrax (post-exposure prophylaxis and treatment)
Common side effects
- Nausea
- Diarrhea
- Headache
- Insomnia
- Tendinitis/tendon rupture
- QT prolongation
- Photosensitivity
- Peripheral neuropathy
Key clinical trials
- A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants (PHASE1, PHASE2)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever (PHASE2)
- A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
- Linezolid for Treatment of Nontuberculous Mycobacterial Diseases (PHASE4)
- The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment (PHASE3)
- Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care (PHASE3)
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 oral tablets CI brief — competitive landscape report
- Levofloxacin oral tablets updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Levofloxacin oral tablets
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Related
- Drug class: All Fluoroquinolone antibiotic drugs
- Target: All drugs targeting DNA gyrase, Topoisomerase IV
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Acute bacterial sinusitis
- Indication: Drugs for Acute bacterial exacerbation of chronic bronchitis
- Compare: Levofloxacin oral tablets vs similar drugs
- Pricing: Levofloxacin oral tablets cost, discount & access