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ZILEUTON
At a glance
| Generic name | ZILEUTON |
|---|---|
| Drug class | 5-Lipoxygenase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
Common side effects
- Headache
- Dyspepsia
- Nausea
- Abdominal pain
- Asthenia
- Diarrhea
- Myalgia
- Arthralgia
- Chest pain
- Conjunctivitis
- Constipation
- Dizziness
Serious adverse events
- ALT elevations ≥3xULN
- Low white blood cell count (≤2.8 x 10^9/L)
- Symptomatic hepatitis with jaundice
- Hyperbilirubinemia
- Sleep disorders
- Behavior changes
- Rash
- Urticaria
Key clinical trials
- Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers (PHASE2)
- Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial (PHASE4)
- Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study) (PHASE3)
- Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease
- Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia (PHASE1)
- Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer (PHASE2)
- Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis (PHASE2)
- Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML. (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ZILEUTON CI brief — competitive landscape report
- ZILEUTON updates RSS · CI watch RSS