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
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.
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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/16/2013 | ||
Authorised | 5/16/2013 | ||
Authorised | 5/27/2015 | ||
Authorised | 3/19/2002 | ||
Authorised | 3/19/2002 |
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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VORICONAZOLE AN voriconazole 200 mg film-coated tablets bottle | 238274 | Medicine | A | 7/22/2016 | |
VFEND voriconazole 50mg tablet blister pack | 82507 | Medicine | A | 9/3/2002 | |
VORICONAZOLE INTERPHARMA voriconazole 200 mg powder for injection vial | 265660 | Medicine | A | 9/16/2016 | |
VORICONAZOLE AN voriconazole 200 mg powder for injection vial | 238275 | Medicine | A | 7/22/2016 | |
VORICONAZOLE GH voriconazole 200 mg film-coated tablets bottle | 238269 | Medicine | A | 7/22/2016 | |
VORICONAZOLE GPPL voriconazole 200 mg powder for injection vial | 238208 | Medicine | A | 7/22/2016 | |
VORICONAZOLE GENPAR voriconazole 200 mg film-coated tablets bottle | 238236 | Medicine | A | 7/22/2016 | |
VORCON voriconazole 50 mg tablet blister pack | 235934 | Medicine | A | 7/27/2016 | |
GenRx Voriconazole voriconazole 200mg tablet blister pack | 218360 | Medicine | A | 1/27/2016 | |
VTTACK voriconazole 50mg film coated tablet blister pack | 206983 | Medicine | A | 9/9/2015 |
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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