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levofloxacin, azithromycin, amoxicillin/clavulanate
levofloxacin, azithromycin, amoxicillin/clavulanate is a Antibiotics Small molecule drug developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. It is currently in Phase 3 development for Community-acquired pneumonia, Acute bacterial sinusitis, Uncomplicated skin and skin structure infections.
Levofloxacin, azithromycin, and amoxicillin/clavulanate inhibit bacterial growth through different mechanisms, targeting DNA gyrase, protein synthesis, and cell wall synthesis, respectively.
Levofloxacin, azithromycin, and amoxicillin/clavulanate inhibit bacterial growth through different mechanisms, targeting DNA gyrase, protein synthesis, and cell wall synthesis, respectively. Used for Community-acquired pneumonia, Acute bacterial sinusitis, Uncomplicated skin and skin structure infections.
At a glance
| Generic name | levofloxacin, azithromycin, amoxicillin/clavulanate |
|---|---|
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Drug class | Antibiotics |
| Target | DNA gyrase, 50S ribosomal subunit, penicillin-binding proteins |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Levofloxacin inhibits DNA gyrase and topoisomerase IV, preventing DNA replication. Azithromycin binds to the 50S ribosomal subunit, inhibiting protein synthesis. Amoxicillin/clavulanate works by disrupting bacterial cell wall synthesis, with clavulanate protecting amoxicillin from degradation by beta-lactamases.
Approved indications
- Community-acquired pneumonia
- Acute bacterial sinusitis
- Uncomplicated skin and skin structure infections
Common side effects
- Nausea
- Diarrhea
- Headache
Key clinical trials
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- The Individualized M(X) Drug-resistant TB Treatment Strategy Study (PHASE4)
- Short-Term Use of Antibiotics and Adherence Level (NA)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis. (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, azithromycin, amoxicillin/clavulanate CI brief — competitive landscape report
- levofloxacin, azithromycin, amoxicillin/clavulanate updates RSS · CI watch RSS
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. portfolio CI
Frequently asked questions about levofloxacin, azithromycin, amoxicillin/clavulanate
What is levofloxacin, azithromycin, amoxicillin/clavulanate?
How does levofloxacin, azithromycin, amoxicillin/clavulanate work?
What is levofloxacin, azithromycin, amoxicillin/clavulanate used for?
Who makes levofloxacin, azithromycin, amoxicillin/clavulanate?
What drug class is levofloxacin, azithromycin, amoxicillin/clavulanate in?
What development phase is levofloxacin, azithromycin, amoxicillin/clavulanate in?
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What does levofloxacin, azithromycin, amoxicillin/clavulanate target?
Related
- Drug class: All Antibiotics drugs
- Target: All drugs targeting DNA gyrase, 50S ribosomal subunit, penicillin-binding proteins
- Manufacturer: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Acute bacterial sinusitis
- Indication: Drugs for Uncomplicated skin and skin structure infections
- Compare: levofloxacin, azithromycin, amoxicillin/clavulanate vs similar drugs
- Pricing: levofloxacin, azithromycin, amoxicillin/clavulanate cost, discount & access