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Voriconazole

Generic Name
Voriconazole
Brand Names
Vfend, Voriconazole Hikma (previously Voriconazole Hospira), Voriconazole Accord
Drug Type
Small Molecule
Chemical Formula
C16H14F3N5O
CAS Number
137234-62-9
Unique Ingredient Identifier
JFU09I87TR

Overview

Voriconazole (Vfend, Pfizer) is a triazole antifungal medication used to treat serious fungal infections. It is used to treat invasive fungal infections that are generally seen in patients who are immunocompromised. These include invasive candidiasis, invasive aspergillosis, and emerging fungal infections. The increased affinity of voriconazole for 14-alpha sterol demethylase makes it useful against some fluconazole-resistant organisms. Voriconazole was approved by the FDA under the trade name Vfend on May 24, 2002.

Indication

For the treatment of esophageal candidiasis, cadidemia, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp.

Associated Conditions

  • Aspergillosis of the Central Nervous System
  • Aspergillosis of the Liver
  • Candidemia
  • Candidiasis
  • Coccidioidomycosis
  • Endocarditis caused by Aspergillus
  • Esophageal Candidiasis
  • Fungal Infections
  • Fungal meningitis caused by Exserohilum Infection
  • Fusarium infection
  • Histoplasmosis
  • Invasive Aspergillosis
  • Osteomyelitis caused by Aspergillus
  • Penicillium marneffei infection
  • Peritonitis caused by Aspergillus
  • Scedosporium Infection
  • Sinusitis aspergillus
  • Aspergillus endophthalmitis
  • Refractory Oral Candidiasis

Research Report

Published: Jul 22, 2025

Voriconazole: A Comprehensive Monograph on its Pharmacology, Clinical Use, and Risk Management

Executive Summary & Drug Profile

Overview

Voriconazole is a second-generation, broad-spectrum triazole antifungal agent, representing a cornerstone in the management of severe, life-threatening invasive fungal infections.[1] As a synthetic derivative of fluconazole, it was engineered for an expanded spectrum of activity, particularly against molds.[4] It is established as the first-line therapy for invasive aspergillosis and is a critical agent for treating infections caused by fluconazole-resistant

Candida species and rare, often refractory, molds such as Scedosporium and Fusarium.[1]

The clinical utility of voriconazole is defined by a central paradox: its potent, life-saving efficacy is counterbalanced by a highly complex pharmacological profile. This profile is characterized by highly variable, non-linear pharmacokinetics, a narrow therapeutic window, and a significant potential for drug-drug interactions and notable toxicities.[3] Consequently, the successful clinical application of voriconazole demands a sophisticated understanding of its properties and a commitment to individualized patient management, including therapeutic drug monitoring, to navigate the fine line between efficacy and toxicity.

Chemical and Physical Identity

A comprehensive chemical and physical profile is essential for the identification, formulation, and research of voriconazole.

Nomenclature and Identifiers

Voriconazole is identified by a range of names and codes that reflect its development and regulatory history.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/08
Phase 2
Not yet recruiting
2024/07/10
Phase 1
Completed
2024/04/30
N/A
Completed
2023/09/21
N/A
Completed
LI YAN
2023/06/09
N/A
NO_LONGER_AVAILABLE
2022/12/19
N/A
Completed
2022/07/14
Phase 1
Terminated
2022/05/18
Phase 4
Completed
2022/03/07
Early Phase 1
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
2022/03/03
Phase 1
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Mylan Institutional Inc.
51079-165
ORAL
200 mg in 1 1
12/23/2021
Mylan Pharmaceuticals Inc.
0378-1640
ORAL
200 mg in 1 1
6/15/2023
Major Pharmaceuticals
0904-7024
ORAL
200 mg in 1 1
11/17/2020
Fosun Pharma USA Inc.
72266-131
INTRAVENOUS
10 mg in 1 mL
1/17/2023
Hainan Poly Pharm. Co., Ltd
14335-220
ORAL
40 mg in 1 mL
1/16/2024
Lupin Pharmaceuticals,Inc.
43386-089
ORAL
200 mg in 1 1
1/31/2024
Alvogen Inc.
47781-466
INTRAVENOUS
10 mg in 1 mL
5/5/2021
Amneal Pharmaceuticals LLC
65162-913
ORAL
40 mg in 1 mL
12/20/2022
Viona Pharmaceuticals Inc
72578-062
ORAL
50 mg in 1 1
2/14/2024
Novel Laboratories, Inc.
40032-038
ORAL
40 mg in 1 mL
12/8/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
VORICONAZOLE SANDOZ FILM COATED TABLET 200MG
SIN14859P
TABLET, FILM COATED
200mg
10/6/2015
VFEND FILM-COATED TABLET 50 mg
SIN12378P
TABLET, FILM COATED
50 mg
8/5/2003
Vfend Powder for Oral Suspension 40mg/ml
SIN13033P
POWDER, FOR SUSPENSION
40mg/ml
10/28/2004
VORICA VORICONAZOLE POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL
SIN16417P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
200 mg/vial
1/10/2022
VORITROP 50 FILM COATED TABLET 50 MG
SIN15848P
TABLET, FILM COATED
50 mg
11/1/2019
VORICONAZOLE – AFT POWDER FOR INJECTION 200MG/VIAL
SIN16906P
INJECTION, POWDER, FOR SOLUTION
200MG/VIAL
12/8/2023
VORICONAZOLE KABI POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL
SIN16509P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
200 mg/vial
6/9/2022
VORITROP 200 FILM COATED TABLET 200 MG
SIN15847P
TABLET, FILM COATED
200 mg
11/1/2019
VFEND FILM-COATED TABLET 200 mg
SIN12379P
TABLET, FILM COATED
200 mg
8/5/2003
VFEND FOR INFUSION 200 mg/vial
SIN12380P
INJECTION, POWDER, FOR SOLUTION
10 mg/ml
8/5/2003

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
VORICONAZOLE NORMON POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200MG
N/A
N/A
N/A
1/31/2020
VORISAM POWDER FOR SOLUTION FOR INFUSION 200MG
N/A
i & c (hong kong) limited
N/A
N/A
3/19/2020
ZOLCYP POWDER FOR SOLUTION FOR INFUSION 200MG
N/A
N/A
N/A
9/10/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACH-VORICONAZOLE
02432005
Tablet - Oral
200 MG
N/A
SANDOZ VORICONAZOLE
02399245
Tablet - Oral
50 MG
4/2/2014
MED-VORICONAZOLE
generic medical partners inc
02457709
Tablet - Oral
200 MG
N/A
TEVA-VORICONAZOLE
teva canada limited
02396874
Tablet - Oral
200 MG
3/31/2014
TEVA-VORICONAZOLE
teva canada limited
02396866
Tablet - Oral
50 MG
3/31/2014
VORICONAZOLE FOR INJECTION
auro pharma inc
02486695
Powder For Solution - Intravenous
200 MG / VIAL
N/A
PMS-VORICONAZOLE
02436353
Powder For Solution - Intravenous
200 MG / VIAL
N/A
AURO-VORICONAZOLE
auro pharma inc
02451395
Tablet - Oral
200 MG
N/A
VORICONAZOLE FOR INJECTION
formative pharma inc.
02544350
Powder For Solution - Intravenous
200 MG / VIAL
N/A
VORICONAZOLE FOR INJECTION
pharmaris canada inc
02467852
Powder For Solution - Intravenous
200 MG / VIAL
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
VORICONAZOL NORMON 200 MG POLVO PARA SOLUCION PARA PERFUSION EFG
Laboratorios Normon S.A.
80941
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
VFEND 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
02212021
COMPRIMIDO RECUBIERTO
Uso Hospitalario
Not Commercialized
VORICONAZOL HIKMA 200 MG POLVO PARA SOLUCION PARA PERFUSION EFG
1151004001
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
VFEND 200 mg POLVO PARA SOLUCION PARA PERFUSION
02212025
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
VFEND 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
02212005
COMPRIMIDO RECUBIERTO
Uso Hospitalario
Commercialized
VORICONAZOL NORMON 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION
Laboratorios Normon S.A.
84789
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
VORICONAZOL FARMAPROJECTS 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Farmaprojects S.A.U.
80074
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized
VORICONAZOL KERN PHARMA 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
80106
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
Voriconazol Accord 200 mg comprimidos recubiertos con pelicula
113835017
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized
Voriconazol Accord 50 mg comprimidos recubiertos con pelicula
113835008
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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