Back to discover
Drug

Voriconazole

Approved · FDA / EMA
ClassCytochrome P450 51 inhibitorEmerging researchLate-stage development
Also known as VCZ, VFEND, Voriconazol, (R-(R*,S*))-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol+1 more

VCZ, VFEND, Voriconazol, (R-(R*,S*))-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol, Voriconazolum.

RxNorm121243ChEMBLCHEMBL638ATCJ02AC03UNIIJFU09I87TR
1
Research papers
3
Active clinical trials
Lanosterol 14-alpha demethylase
Primary target
16
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Clinical Study Evaluating the Effects of Dexamethasone on the Activities of CYP2C9, CYP2C19, and CYP3A4 Substrates in Healthy Male Subjects

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

Clinical Study on the Drug Interaction Between Buagafuran Capsules and Voriconazole Tablets in Chinese Adult Healthy Participants

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

A Study of Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

Clinical trial2026-01-23Results posted · ClinicalTrials.gov

Label change: VORICONAZOLE (ANDA203503)

Regulatory2025-09-16FDA

Comparing the Efficacy of Oral 200 Milligram Voriconazole Once a Day Vs. Twice a Day in the Treatment of Resisitant Dermatophyte Infections (Tinea Corporis and Tinea Cruris)

Clinical trial2025-03-01Primary completion · ClinicalTrials.gov

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.

Clinical trial2024-12-10Results posted · ClinicalTrials.gov

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

Clinical trial2024-12-10Results posted · ClinicalTrials.gov

A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a Single Dose of Repotrectinib (BMS-986472) in Healthy Participants

Clinical trial2024-12-07Completed · ClinicalTrials.gov

Label change: VORICONAZOLE (ANDA203503)

Regulatory2022-11-29FDA

Label change: VORICONAZOLE (ANDA203503)

Regulatory2022-11-29FDA

Label change: VORICONAZOLE (ANDA203503)

Regulatory2022-06-13FDA

Defining and managing COVID-19-associated pulmonary aspergillosis: the 2020 ECMM/ISHAM consensus criteria for research and clinical guidance.

Research2020-12-14The Lancet. Infectious diseases

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Voriconazole
Aliases & brands
VCZVFENDVoriconazol(R-(R*,S*))-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanolVoriconazolum
RxNorm CUI
121243
ChEMBL ID
CHEMBL638
ATC codes
J02AC03
UNII
JFU09I87TR
Primary mechanism
Cytochrome P450 51 inhibitor
Regulatory jurisdictions
fdaemamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Lanosterol 14-alpha demethylase
ERG11 · P10613
INHIBITORCytochrome P450 51 inhibitor

Regulatory timeline

16 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2002-03-19
Latest approval
2015-09-02
Authorities
FDA · EMA · MHRA
Total events
16
fdaU.S. Food and Drug Administration· 12 events
2025-09-16Label change
Label change: VORICONAZOLE (ANDA203503)
Evidence ↗
2022-11-29Label change
Label change: VORICONAZOLE (ANDA203503)
Evidence ↗
2022-11-29Label change
Label change: VORICONAZOLE (ANDA203503)
Evidence ↗
emaEuropean Medicines Agency· 3 events
2015-05-27Approval
Approval: Voriconazole Hikma (previously Voriconazole Hospira) (EMA)
Indication: Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis;… Show full indication

Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.

Evidence ↗
2013-05-16Approval
Approval: Voriconazole Accord (EMA)
Indication: Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis;… Show full indication

Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.

Evidence ↗
2002-03-19Approval
Approval: Vfend (EMA)
Indication: Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis;… Show full indication

Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemianon-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Voriconazole: reminder of risk of liver toxicity, phototoxicity, and squamous cell carcinoma
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

87 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
87
registered trials across all phases
LATEST COMPLETION 2024
3
Active studies
3
Recruiting
48
Late-stage (III+)
64
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 87
Early Phase 11Phase 123Phase 1 / 23Phase 212Phase 2 / 32Phase 325Phase 414Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Case Series of Continuously-infused Amphotericin-B and Follow-up Voriconazole Therapy for Severe Blastomycosis Pulmonary Infections

TerminatedPH IVUniversity of Manitoban=22020

Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus

CompletedPH IVUniversitaire Ziekenhuizen KU Leuvenn=242017

Efficacy and Safety of Voriconazole for Treatment of Invasive Pulmonary Aspergillosis Secondary to COPD: a Multi-center Prospective，Open Cohort Study (VIA-COPD)

Unknown statusPH IVRed Cross Hospital, Hangzhou, Chinan=402016

A Double-Blind, Randomized Controlled Trial of Voriconazole (VFEND®) Plus Micafungin (MYCAMINE™) Versus Voriconazole Plus Placebo in the Treatment of Patients With Proven or Probable Invasive Aspergillosis

WithdrawnPH IVAstellas Pharma Inc2015

Assessment of Target Site Pharmacokinetics of Voriconazole in Healthy Volunteers During Sequence Therapy

CompletedPH IVMartin-Luther-Universität Halle-Wittenbergn=92013

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a Single Dose of Repotrectinib (BMS-986472) in Healthy Participants

CompletedPH IBristol-Myers Squibbn=322024

A Study of Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

CompletedPH IINational Cancer Institute (NCI)n=102024

A Randomized Controlled Trial to Compare the Clinical Outcomes With Six Months of Therapy With Oral Itraconazole Versus Oral Voriconazole for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis

CompletedPH IIIPost Graduate Institute of Medical Education and Research, Chandigarhn=1162024

A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

CompletedPH IBeiGenen=262022

A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFI) Following Allogeneic Hematopoietic Cell Transplantation (HCT)

CompletedPH IIIChildren's Oncology Groupn=2922021

A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis

CompletedPH IIIAsahi Kasei Therapeutics Corporationn=1032021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • The Lancet. Infectious diseases1
Leading researchers
  • Bassetti M1
  • Böll B1
  • Brüggemann R1
  • Chakrabarti A1
  • Chen SCA1
  • Colombo AL1
  • Cornely OA1
  • Gangneux JP1
Leading institutions
free-text, unnormalised
  • Center of Expertise in Mycology Radboudumc/CWZ1
  • Centre for Infectious Diseases and Microbiology Laboratory Services1
  • Clinical and Translational Fungal-Working Group and Division of Infectious Diseases and Global Public Health1
  • College of Medicine1
  • Department of Clinical Mycology1
  • Duke University Medical Center1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Amphotericin B

Studied across 3 of the same disease areas as Voriconazole in the shared literature.

3 shared diseases1 shared paper
Isavuconazole

Studied across 3 of the same disease areas as Voriconazole in the shared literature.

3 shared diseases1 shared paper
liposomal amphotericin B

Studied across 3 of the same disease areas as Voriconazole in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.