NDAORALTABLET
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
ZYFLO (zileuton) by Chiesi is 5-lipoxygenase inhibitors [moa]. Approved for 5-lipoxygenase inhibitor [epc]. First approved in 1996.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYFLO (zileuton) is an oral 5-lipoxygenase inhibitor approved in 1996 for asthma management. It reduces inflammatory mediators (leukotrienes) that drive airway constriction and inflammation. The drug targets patients with persistent asthma who require controller therapy.
$0.003BPart D
LOE ApproachingDeclining
Modest Part D utilization with shrinking claims volume signals a mature, niche product with limited commercial team expansion.
Mechanism of Action
5-Lipoxygenase Inhibitors
Pharmacologic Class:
5-Lipoxygenase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia
Started Jan 2014
2 enrolled
Chronic Myelogenous Leukemia
Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
Started Dec 2003
140 enrolled
Lung Cancer
Career Relevance
ZYFLO offers limited career growth prospects due to mature lifecycle, low utilization (636 Part D claims in 2023), and approaching loss of exclusivity. Roles available are primarily defensive—maintaining market share through payer negotiations and specialist engagement rather than launching new indications or expanding markets.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.