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Avelox
At a glance
| Generic name | Avelox |
|---|---|
| Sponsor | Novartis Pharmaceuticals |
| Target | DNA gyrase, DNA gyrase subunit A, DNA topoisomerase 4 subunit A |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
- Abdominal abscess
- Acute bacterial sinusitis
- Acute exacerbation of chronic bronchitis
- Bacterial conjunctivitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial pneumonia
- Chlamydial pneumonia
- Complicated Skin and Skin Structure E. Coli Infection
- Complicated Skin and Skin Structure Infection
- Complicated Skin and Skin Structure Staphylococcus Aureus Infection
- Haemophilus Influenzae Chronic Bronchitis
- Haemophilus Parainfluenzae Chronic Bronchitis
- Haemophilus influenzae pneumonia
- Infection due to Enterobacteriaceae
- Infection due to Staphylococcus aureus
- Infection of skin AND/OR subcutaneous tissue
- Infectious disease of abdomen
- Klebsiella Pneumoniae Chronic Bronchitis
- Moraxella Catarrhalis Chronic Bronchitis
- Moraxella Catarrhalis Pneumonia
Common side effects
- Nausea
- Diarrhea
- Headache
- Dizziness
Serious adverse events
- Hepatic failure (including fatal cases)
- Anaphylactic shock
- Anaphylactic reaction
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Tendon rupture
- Angioedema (including laryngeal edema)
- Acute hepatic necrosis
- Hepatitis (predominantly cholestatic)
- Pancytopenia
Key clinical trials
- Shortened Regimen for Drug-susceptible TB in Children (PHASE3)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Study to Evaluate the Effect of BMS-986278 on Cardiac Repolarization in Healthy Participants (PHASE1)
- A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity (PHASE1)
- A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) (PHASE1)
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD. (PHASE1)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |