NDAORALCAPSULE
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
SPORANOX (itraconazole) by Johnson & Johnson is cytochrome p450 3a4 inhibitors [moa]. First approved in 1996.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPORANOX (itraconazole) is an oral triazole antifungal that inhibits fungal cytochrome P450 3A4, disrupting ergosterol synthesis in the fungal cell membrane. It treats a broad spectrum of fungal infections across multiple body systems. The drug is administered as oral capsules, offering convenient outpatient management compared to intravenous alternatives.
LOE Approaching
LOE approaching creates urgency for lifecycle extension strategies and cost management; team focus likely shifting toward generic transition planning and retained-market defense.
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants
Started Dec 2026
80 enrolled
Healthy Adult Subject
Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants
Started May 2026
28 enrolled
Healthy Volunteers (HV)
A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.
Started May 2026
14 enrolled
Healthy Participant
A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017)
Started May 2026
14 enrolled
Healthy
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole
Started Apr 2026
28 enrolled
Healthy Participants
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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.