NDAORALTABLET
Approved
Apr 2010
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
4/8 — Partial
ONMEL (itraconazole) by Bel Air Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. First approved in 2010.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONMEL is an oral itraconazole tablet approved in 2010 as a cytochrome P450 3A4 inhibitor used to treat fungal infections. It works by disrupting ergosterol synthesis in fungal cell membranes, making it effective against a broad spectrum of fungal pathogens. Itraconazole is a foundational antifungal agent with decades of clinical use across multiple indications.
LOE Approaching2.3 years to LOE
Competitive pressure score of 15 indicates a saturated market with limited differentiation, suggesting smaller commercial teams focused on retention and generic mitigation strategies.
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
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
Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants
Started May 2026
28 enrolled
Healthy Volunteers (HV)
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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.