TheraRadar
Data updated: May 26, 2026

VORICONAZOLE

Cytochrome P450 3A4 Inhibitors
Infectious Disease Approved 2010-04-22

Voriconazole is a broad-spectrum triazole antifungal indicated for use in adults and pediatric patients (2 years and older). It is used for the treatment of invasive aspergillosis, esophageal candidiasis, and candidemia in non-neutropenic patients (including disseminated skin, abdomen, kidney, bladder wall, and wound infections). Additionally, it is indicated for serious fungal infections caused by *Scedosporium apiospermum* and *Fusarium* species in patients who are intolerant of, or refractory to, other therapies.

Source: FDA Label • RISING • Azole Antifungal
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How VORICONAZOLE Works

Voriconazole is a triazole antifungal that inhibits fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation. This inhibition prevents the synthesis of ergosterol, a vital component of fungal cell membranes. The resulting depletion of ergosterol and accumulation of methylated sterol precursors lead to alterations in membrane permeability and subsequent inhibition of fungal growth or cell death.

Source: FDA Label
26
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2010-04-22
Routes
ORAL, INTRAVENOUS, INJECTION
Dosage Forms
FOR SUSPENSION, POWDER, TABLET, SOLUTION, INJECTABLE

Companies

RISING ASPIRO SLATE RUN PHARMA Teva Novartis CHARTWELL RX ZYDUS PHARMS GLENMARK PHARMS LTD UBI HAINAN POLY PHARM Viatris ALMAJECT PRINSTON INC CADILA ZHEJIANG NOVUS AMNEAL PHARMS NOVEL LABS INC HETERO LABS LTD V AJANTA PHARMA LTD Aurobindo Pharma Hikma EUGIA PHARMA PHARMOBEDIENT GLAND ZHEJIANG POLY PHARM EPIC PHARMA LLC MEITHEAL
Active Ingredient: VORICONAZOLE

VORICONAZOLE Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
246 FDA actions from 2010 to 2026
May 2026 ORIGINAL
Update
Nov 2025 ORIGINAL
Update
FDA Letter
Oct 2025 SUPPL
Label · Labeling

What VORICONAZOLE Treats

5 indications

VORICONAZOLE is approved for 5 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Invasive Aspergillosis
  • Candidemia
  • Candida Infections
  • Esophageal Candidiasis
  • Scedosporiosis
Source: FDA Label

VORICONAZOLE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

MICAFUNGIN IN SODIUM CHLORIDE 0.9%
Baxter
2023 6 indic.
REZZAYO
MUNDIPHARMA
2023 4 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to VORICONAZOLE

3 of 14

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

VFEND
VORICONAZOLE
5 shared
PF PRISM CV
Shared indications:
Invasive AspergillosisCandidemiaCandida Infections +2 more
CASPOFUNGIN ACETATE
CASPOFUNGIN ACETATE
3 shared
PHARMOBEDIENT
Shared indications:
CandidemiaEsophageal CandidiasisInvasive Aspergillosis
ERAXIS
ANIDULAFUNGIN
3 shared
Pfizer
Shared indications:
CandidemiaCandida InfectionsEsophageal Candidiasis
View all 14 similar drugs Pro
📋

Clinical Trial Registry

40 trials
Trial Sponsor ID Phase Status Title
NCT07457203 BJXH-BGFN-202502 Ph 1 not yet recruiting Study on the Drug Interaction Between Buagafuran and Voriconazole
NCT07426042 Dexamethasone_cocktail Ph 1 not yet recruiting Effect of Dexamethasone on CYP Enzyme Activity in Healthy Male Subjects
NCT04294641 results posted 200058 20-C-0058 Ph 2 completed Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
NCT06493409 CA127-1072 Ph 1 completed A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
NCT04865419 results posted D8241C00001 2020-005106-25 Ph 1 terminated Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
NCT02014558 results posted 2215-CL-0101 Ph 1, Ph 2 completed Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT05458102 results posted GS-US-382-1587 Ph 1 terminated Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
NCT04551963 results posted BGB-3111-113 Ph 1 completed Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
NCT01503515 results posted ACCL1131 NCI-2012-00102, CDR0000721415 Ph 3 completed Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
NCT03672292 SCYNERGIA results posted SCY-078-206 2018-002565-18 Ph 2 terminated Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
NCT01782131 results posted P06200 5592-069, 2011-003938-14 Ph 3 completed A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)
NCT03471988 AK1820-301 Ph 3 completed Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
NCT01950507 130197 13-H-0197 Ph 1 terminated Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease
NCT02180165 results posted 5592-101 142639, MK-5592-101 Ph 3 completed Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
NCT02283905 BLASTO B2014:032 Ph 4 terminated Amphotericin-B and Voriconazole for Pulmonary Blastomycosis
NCT02576366 TacDDI151010 Ph 4 completed Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
NCT02227797 2013LS126 MT2013-37R Ph 1 completed MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients
NCT00997035 MUTTII results posted H9332-33965-02_2 U10EY018573 Ph 3 completed The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo
NCT00792246 Pro00004318 Ph 1 completed Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease
NCT00996736 MUTT I results posted H9332-33965-02 U10EY018573-01A1 Ph 3 completed Mycotic Ulcer Treatment Trial I
NCT03515382 GLPG1690-CL-106 2017-004357-16 Ph 1 completed 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
NCT01621321 ABPA/003 Ph 2, Ph 3 completed Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis
NCT02381080 CR106609 PCI-32765LYM1003, 2015-000325-36 Ph 1 completed Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
NCT00836875 results posted A1501080 2008-005275-10 Ph 3 terminated A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
NCT01787032 results posted 1314.7 2012-002538-36 Ph 1 completed Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
NCT00893555 VORI911 VORI911 Ph 3 completed Pharmacologic Optimization of Voriconazole
NCT01092832 results posted A1501085 2009-012848-16 Ph 3 terminated A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
NCT00556998 results posted A1501081 Ph 2 completed A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
NCT01383993 results posted A1501096 Ph 2 completed Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
NCT01539330 VORTarget-site KP-VOR03 2008-008524-32 Ph 4 completed Assessment of Target Site Pharmacokinetics of Voriconazole in Healthy Volunteers During Sequence Therapy
NCT00833482 results posted AI424-383 2009-009095-13 Ph 1 completed Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants
NCT00904995 results posted 2008-0443 Ph 3 completed Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
NCT01188759 A1501095 Ph 3 withdrawn Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
NCT00531479 results posted A8851009 Ph 3 completed Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
NCT01080651 SNUCPT09_Vori2C19_B Ph 1 completed Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole
NCT00689338 ICE results posted A8851019 Ph 3 completed Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
NCT00548262 results posted A8851015 Ph 4 completed This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis
NCT00855101 A1501092 Ph 1 completed A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
NCT00942773 SNUCPT09_Vori2C19_A Ph 1 completed Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
NCT00620074 results posted A8851014 Ph 4 terminated Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VORICONAZOLE FDA Label Details

Indications & Usage

FDA Label (PDF)

VORICONAZOLE is indicated for the treatment of Invasive Aspergillosis; Candidemia; Candida Infections; Esophageal Candidiasis; Scedosporiosis.

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VFEND

Full clinical data, patents, trials, and competitive landscape for voriconazole.

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Data Sources

FDA Approval: ANDA202361 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.