NDAORALCAPSULE
Approved
Dec 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
TOLSURA (itraconazole) by Bel Air Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. First approved in 2018.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOLSURA (itraconazole) is an oral azole antifungal that inhibits cytochrome P450 3A4, disrupting ergosterol synthesis in fungal cell membranes. It is indicated for systemic fungal infections in patients who require oral antifungal therapy. The drug represents a formulation innovation of a well-established antifungal class.
$0.769MPart D
Peak7.0 years to LOEProduct is at peak lifecycle stage with modest Medicare spending ($769K in 2023), suggesting a niche market position that limits team expansion opportunities.
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 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)
Worked on TOLSURA at Bel Air Pharmaceuticals? 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.