NDAORALCAPSULE
Approved
Dec 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
TOLSURA (itraconazole) by Bel Air Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. Approved for hiv infection, histoplasmosis, blastomycosis and 1 more indications. First approved in 2018.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOLSURA is an oral azole antifungal containing itraconazole that works by inhibiting fungal cytochrome P450 3A4, disrupting ergosterol synthesis. It is indicated for serious fungal infections including histoplasmosis, blastomycosis, and oral candidiasis, as well as antifungal prophylaxis in immunocompromised patients. The drug also has emerging applications in oncology for conditions including non-small cell lung cancer and anaplastic large cell lymphoma.
$0.769MPart D
Peak7.1 years to LOETOLSURA is in peak lifecycle with modest Medicare Part D spending ($769K in 2023, 230 claims), indicating a niche specialty product with limited commercial team expansion potential.
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
Pharmacologic Class:
Azole Antifungal
Indications (4)
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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.