Voriconazole - PharmaKB

Vfend(voriconazole)

Vfend, Voriconazole (voriconazole) is a small molecule pharmaceutical. Voriconazole was first approved as Vfend on 2002-03-19. It is used to treat aspergillosis, candidiasis, fusariosis, and mycoses in the USA. It has been approved in Europe to treat aspergillosis, bacterial infections and mycoses, candidiasis, and mycoses.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Vfend, Voriconazole (discontinued: Voriconazole)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Voriconazole

Tradename	Company	Number	Date	Products
VORICONAZOLE	Hikma Pharmaceuticals	N-208562 RX	2017-03-09	1 products
VFEND	CV Sciences	N-021266 RX	2002-05-24	2 products, RLD, RS
VFEND	CV Sciences	N-021267 RX	2002-05-24	1 products, RLD, RS
VFEND	CV Sciences	N-021630 RX	2003-12-19	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
vfend	New Drug Application	2025-02-12
vfender	OTC monograph not final	2020-05-30
vfender hand sanitizer gel	OTC monograph not final	2020-09-01
voriconazole	ANDA	2025-01-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
mycoses	—	D009181	B35-B49
candidiasis	—	D002177	B37
aspergillosis	EFO_0007157	D001228	B44
fusariosis	EFO_1001795	D060585	—

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J02: Antimycotics for systemic use

— J02A: Antimycotics for systemic use

— J02AC: Triazole and tetrazole derivatives

— J02AC03: Voriconazole

HCPCS

Code	Description
J3465	Injection, voriconazole, 10 mg

Clinical

Clinical Trials

195 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Mycoses	D009181	—	B35-B49	8	9	19	10	21	66
Aspergillosis	D001228	EFO_0007157	B44	4	11	14	7	7	40
Infections	D007239	EFO_0000544	—	3	7	8	3	9	29
Invasive fungal infections	D000072742	—	—	—	3	5	4	9	21
Invasive pulmonary aspergillosis	D055744	—	B44.0	1	3	4	2	6	16
Communicable diseases	D003141	—	—	2	4	4	2	4	16
Healthy volunteers/patients	—	—	—	12	—	—	3	1	16
Candidiasis	D002177	—	B37	2	2	5	3	1	13
Pulmonary aspergillosis	D055732	EFO_1001834	—	1	4	5	1	3	12
Hematologic neoplasms	D019337	—	—	2	2	2	1	2	8

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	5	8	4	—	3	16
Neoplasms	D009369	—	C80	3	7	1	—	3	13
Myeloid leukemia	D007951	—	C92	5	9	1	—	1	11
Myeloid leukemia acute	D015470	—	C92.0	5	8	1	—	1	10
Keratitis	D007634	—	H16	2	2	2	—	3	7
Hiv infections	D015658	EFO_0000764	B20	3	—	1	—	1	5
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	3	—	1	—	1	5
Corneal ulcer	D003320	—	H16.0	1	—	3	—	1	5
Neutropenia	D009503	—	D70	1	2	1	—	2	5
Syndrome	D013577	—	—	1	2	1	—	1	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myelodysplastic syndromes	D009190	—	D46	1	3	—	—	1	4
Graft vs host disease	D006086	—	D89.81	2	1	—	—	1	4
Preleukemia	D011289	—	—	1	3	—	—	—	3
Lymphoid leukemia	D007945	—	C91	3	2	—	—	—	3
Pharmacokinetics	D010599	—	—	1	1	—	—	1	3
Hematopoietic stem cell transplantation	D018380	—	—	1	1	—	—	1	3
Pain	D010146	EFO_0003843	R52	—	1	—	—	1	2
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	2	2	—	—	—	2
Multiple myeloma	D009101	—	C90.0	—	1	—	—	1	2
Recurrence	D012008	—	—	1	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Asthma	D001249	EFO_0000270	J45	1	—	—	—	1	2
Stem cell transplantation	D033581	—	—	2	—	—	—	—	2
Phototoxic dermatitis	D017484	—	—	1	—	—	—	1	2
Hiv-1	D015497	—	—	1	—	—	—	—	1
Bacterial infections	D001424	—	A49	1	—	—	—	—	1
B-cell lymphoma	D016393	—	—	1	—	—	—	—	1
Anesthesia	D000758	—	—	1	—	—	—	—	1
Meningitis	D008581	EFO_0000584	G03	1	—	—	—	—	1
Cryptococcal meningitis	D016919	EFO_0007228	B45.1	1	—	—	—	—	1
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	4	4
Covid-19	D000086382	—	U07.1	—	—	—	—	2	2
Hematologic diseases	D006402	EFO_0005803	D75.9	—	—	—	—	2	2
Bone marrow transplantation	D016026	—	—	—	—	—	—	2	2
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Heart failure	D006333	EFO_0003144	I50	—	—	—	—	1	1
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Coronavirus infections	D018352	EFO_0007224	B34.2	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Voriconazole
INN	voriconazole
Description	Voriconazole is a triazole-based antifungal agent used for the treatment of esophageal candidiasis, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp. It is an inhibitor of cytochrome P450 2C9 (CYP2C9) and CYP3A4. It has a role as a P450 inhibitor. It is a member of pyrimidines, a difluorobenzene, a tertiary alcohol, a triazole antifungal drug and a conazole antifungal drug.
Classification	Small molecule
Drug class	systemic antifungals (miconazole type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F