NDAINTRAVENOUSPOWDER2 Generics Approved
Approved
Mar 2017
Lifecycle
Peak
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
4/8 — Partial
VORICONAZOLE (voriconazole) by Hikma is cytochrome p450 3a4 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Voriconazole is an azole antifungal agent that works by inhibiting cytochrome P450 3A4, disrupting fungal cell membrane synthesis. It is administered intravenously as a powder formulation and treats serious invasive fungal infections including aspergillosis, candidiasis, and other mycoses. This drug is indicated for critically ill immunocompromised patients requiring parenteral antifungal therapy.
Peak
Voriconazole is at peak commercial maturity with Hikma as sponsor; expect stable to declining team growth as generic pressure from VFEND (Pfizer) increases.
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)
Study on the Drug Interaction Between Buagafuran and Voriconazole
Started Apr 2026
18 enrolled
Drug Drug Interaction (DDI)
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Started Aug 2024
32 enrolled
Healthy Volunteers
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets
Started Dec 2019
16 enrolled
AnesthesiaSedation
Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
Started Jan 2019
22 enrolled
Invasive Pulmonary Aspergillosis
A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers
Started Mar 2018
18 enrolled
Healthy
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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.