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voriconazole (VFEND®)
voriconazole (VFEND®) is a Azole antifungal Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Treatment of invasive aspergillosis, Treatment of candidemia and other forms of invasive candidiasis, Treatment of serious fungal infections caused by Scedosporium apiospermum and Fusarium species. Also known as: Vfend, UK-109,496; Vfend; voriconazole.
Voriconazole is an antifungal medication that inhibits the synthesis of ergosterol, an essential component of fungal cell membranes.
Voriconazole, also known as VFEND, is a small molecule inhibitor of the cytochrome P450 51 enzyme, specifically targeting lanosterol 14-alpha demethylase. It is used to treat various serious fungal infections, including invasive pulmonary aspergillosis, as indicated by clinical trials on ClinicalTrials.gov.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | voriconazole (VFEND®) |
|---|---|
| Also known as | Vfend, UK-109,496; Vfend; voriconazole |
| Sponsor | Pfizer |
| Drug class | Azole antifungal |
| Target | Lanosterol 14α-demethylase |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
It achieves this by targeting the enzyme lanosterol 14α-demethylase, which is necessary for the conversion of lanosterol to ergosterol. This action disrupts the integrity of the fungal cell membrane, ultimately leading to cell death.
Approved indications
- Treatment of invasive aspergillosis
- Treatment of candidemia and other forms of invasive candidiasis
- Treatment of serious fungal infections caused by Scedosporium apiospermum and Fusarium species
Common side effects
- Headache
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Rash
- Hypersensitivity reactions
- Liver enzyme elevations
- Renal impairment
Key clinical trials
- Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels (PHASE1)
- Phototoxicity of Frequently Prescribed Medicines (NA)
- Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients
- The Antibiogram and Outcomes of Antimicrobial Regimens in Microbial Keratitis: A Prospective Cohort Study
- A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069) (PHASE3)
- Drug-Drug Interaction Study of Voriconazole With Clarithromycin. (PHASE4)
- An Individualized Administration Research of Voriconazole Based on CYP2C19 Gene Polymorphism and TDM
- PCR Based Detection of Azole Resistance in A. Fumigatus to Improve Patient Outcome.
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- voriconazole (VFEND®) CI brief — competitive landscape report
- voriconazole (VFEND®) updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about voriconazole (VFEND®)
What is voriconazole (VFEND®)?
How does voriconazole (VFEND®) work?
What is voriconazole (VFEND®) used for?
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Is voriconazole (VFEND®) also known as anything else?
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What does voriconazole (VFEND®) target?
Related
- Drug class: All Azole antifungal drugs
- Target: All drugs targeting Lanosterol 14α-demethylase
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Treatment of invasive aspergillosis
- Indication: Drugs for Treatment of candidemia and other forms of invasive candidiasis
- Indication: Drugs for Treatment of serious fungal infections caused by Scedosporium apiospermum and Fusarium species
- Also known as: Vfend, UK-109,496; Vfend; voriconazole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing