NDAORALCAPSULEPriority Review
Approved
Sep 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
SPORANOX (itraconazole) by Johnson & Johnson is cytochrome p450 3a4 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 1992.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPORANOX (itraconazole) is an oral azole antifungal that inhibits fungal cytochrome P450 3A4, disrupting ergosterol synthesis in fungal cell membranes. It is indicated for treatment of fungal infections across multiple body systems, including aspergillosis, blastomycosis, and onychomycosis. The capsule formulation allows convenient oral dosing for systemic antifungal therapy.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30/100), signaling potential downsizing or transition planning on the brand team.
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
Pharmacologic Class:
Azole Antifungal
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
Effect of a Known P-glycoprotein (P-gp) Inhibitor, Itraconazole, on the Pharmacokinetics (PK) of Engasertib
Started Sep 2026
27 enrolled
Healthy Participants
A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
Started Aug 2026
30 enrolled
Healthy Participants
A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder
Started Aug 2026
20 enrolled
Bipolar Disorder
Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants
Started Jul 2026
32 enrolled
Healthy
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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.