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 1h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONMEL is an oral tablet formulation of itraconazole, a triazole antifungal agent approved in 2010. It works by inhibiting cytochrome P450 3A4, disrupting ergosterol synthesis in fungal cell membranes. ONMEL treats various fungal infections in patients who require systemic antifungal therapy.
LOE Approaching1.9 years to LOE
As LOE approaches in 2028, the brand team is likely contracting; roles will shift toward managing generic transition and protecting remaining market share against 15 direct competitors.
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
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Started Oct 2026
120 enrolled
DermatophytosisTinea CorporisTinea Cruris+2 more
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 Sep 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
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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.