VFEND (voriconazole)
VFEND is an azole antifungal indicated for use in adults and pediatric patients aged two years and older. It is used to treat invasive aspergillosis, esophageal candidiasis, and candidemia in non-neutropenic patients, as well as other deep tissue Candida infections (including disseminated skin, abdominal, 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.
How VFEND Works
Voriconazole is a triazole antifungal agent. Its primary mechanism of action is the inhibition of fungal cytochrome P450-mediated 14-alpha-lanosterol demethylation, a critical step in fungal ergosterol biosynthesis. The resulting depletion of ergosterol and accumulation of methylated sterol precursors lead to alterations in the functions of the fungal cell membrane, resulting in growth inhibition or cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-05-24
- Routes
- ORAL, INTRAVENOUS, Iv (Infusion), Oral, Injection
- Dosage Forms
- TABLET, POWDER, Injectable, Tablet, FOR SUSPENSION
VFEND Approval History
What VFEND Treats
5 indicationsVFEND is approved for 5 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Invasive Aspergillosis
- Candidemia
- Candida Infections
- Esophageal Candidiasis
- Scedosporiosis
VFEND Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
41 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 |
| NCT01887457 PIVOTAL | 13_DOG06_172 2013-002578-34 | Ph 2 | suspended | Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy |
| 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) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
VFEND FDA Label Details
Indications & Usage
FDA Label (PDF)VFEND is indicated for the treatment of Invasive Aspergillosis; Candidemia; Candida Infections; Esophageal Candidiasis; Scedosporiosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment