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 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOLSURA is an oral azole antifungal containing itraconazole, a cytochrome P450 3A4 inhibitor used to treat systemic fungal infections. The drug works by inhibiting fungal cell membrane synthesis through blockade of lanosterol 14α-demethylase. It is indicated for patients requiring oral antifungal therapy who may benefit from improved bioavailability formulations.
$0.769MPart D
Peak6.6 years to LOEProduct is in peak commercial stage with modest Part D spending (~$769K, 230 claims in 2023), indicating niche positioning within the antifungal market with limited 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
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
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.