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 8h 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 various fungal infections including aspergillosis, blastomycosis, and onychomycosis. The drug is a small-molecule oral capsule approved by FDA in 1992.
LOE Approaching
As LOE approaches, commercial teams are preparing for generic erosion and focusing on niche indications and brand loyalty initiatives rather than volume growth.
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
A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants
Started Jun 2026
12 enrolled
Healthy Volunteer
A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
Started Jun 2026
30 enrolled
Healthy Volunteers
A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants
Started May 2026
14 enrolled
Healthy
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
Worked on SPORANOX at Johnson & Johnson? Share your interview experience or compensation data (+7 days Pro)
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.