Valganciclovir - PharmaKB

Valganciclovir

Valcyte, Valganciclovir (valganciclovir) is a small molecule pharmaceutical. Valganciclovir was first approved as Valcyte on 2001-03-29. It is used to treat aids-related opportunistic infections, cytomegalovirus infections, and cytomegalovirus retinitis in the USA.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
eye diseases	D005128
immune system diseases	D007154

Trade Name

FDA

EMA

Valcyte, Valganciclovir (discontinued: Valganciclovir)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Valganciclovir hydrochloride

Tradename	Company	Number	Date	Products
VALCYTE	CHEPLAPHARM Arzneimittel	N-021304 RX	2001-03-29	1 products, RLD, RS
VALCYTE	CHEPLAPHARM Arzneimittel	N-022257 RX	2009-08-28	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
valcyte	New Drug Application	2025-01-10
valganciclovir	ANDA	2025-03-10
valganciclovir hydrochloride	ANDA	2024-05-27
valganciclovir hydrochloride for oral	ANDA	2023-10-17

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cytomegalovirus infections	EFO_0001062	D003586	B25
aids-related opportunistic infections	—	D017088	—
cytomegalovirus retinitis	EFO_1001302	D017726	—

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag
Valganciclovir Hydrochloride, Valcyte, Cheplapharm
8889109	2027-12-11	DP
9642911	2027-12-11	DP

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors

— J05AB14: Valganciclovir

HCPCS

No data

Clinical

Clinical Trials

124 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cytomegalovirus infections	D003586	EFO_0001062	B25	4	14	24	9	11	58
Infections	D007239	EFO_0000544	—	1	7	9	5	4	25
Communicable diseases	D003141	—	—	—	3	8	3	1	15
Kidney transplantation	D016030	—	—	2	3	4	2	1	10
Hiv infections	D015658	EFO_0000764	B20	—	2	4	1	1	7
Castleman disease	D005871	EFO_1001332	D47.Z2	—	2	—	1	—	3
Leukemia	D007938	—	C95	—	1	—	1	1	3
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	—	1	—	1	1	3
Lymphoid leukemia	D007945	—	C91	—	1	—	1	1	3
Viremia	D014766	—	B34.9	—	1	—	1	1	3

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cytomegalovirus	D003587	—	—	—	2	6	—	1	8
Deafness	D003638	EFO_0001063	H91.9	—	3	3	—	—	5
Hearing loss	D034381	EFO_0004238	H91.9	—	2	2	—	—	4
Kidney diseases	D007674	EFO_0003086	N08	2	2	1	—	—	3
Cytomegalovirus retinitis	D017726	EFO_1001302	—	—	—	2	—	1	3
Retinitis	D012173	—	H30.9	—	—	2	—	1	3
Sensorineural hearing loss	D006319	—	H90.5	—	1	2	—	—	3
Hematopoietic stem cell transplantation	D018380	—	—	—	—	2	—	—	2
Pneumonia	D011014	EFO_0003106	J18	—	1	1	—	—	1
Tuberculosis	D014376	EFO_0000774	A15-A19	—	1	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoproliferative disorders	D008232	Orphanet_2442	D47.9	1	6	—	—	1	7
Lymphoma	D008223	—	C85.9	1	5	—	—	1	6
Epstein-barr virus infections	D020031	EFO_0000769	—	2	6	—	—	—	6
Neoplasms	D009369	—	C80	3	2	—	—	—	5
Carcinoma	D002277	—	C80.0	5	2	—	—	—	5
Glioblastoma	D005909	EFO_0000515	—	1	2	—	—	2	4
Human herpesvirus 8	D019288	—	—	—	3	—	—	—	3
Syndrome	D013577	—	—	1	2	—	—	1	3
Hepatocellular carcinoma	D006528	—	C22.0	3	2	—	—	—	3
Stomach neoplasms	D013274	EFO_0003897	C16	1	1	—	—	1	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Liver transplantation	D016031	EFO_0010682	—	1	—	—	—	1	2
Nasopharyngeal carcinoma	D000077274	—	—	2	—	—	—	—	2
Nasopharyngeal neoplasms	D009303	—	—	2	—	—	—	—	2
Healthy volunteers/patients	—	—	—	2	—	—	—	—	2
Fibrosis	D005355	—	—	1	—	—	—	—	1
Idiopathic pulmonary fibrosis	D054990	—	J84.112	1	—	—	—	—	1
Pulmonary fibrosis	D011658	—	J84.10	1	—	—	—	—	1
Cystic fibrosis	D003550	EFO_0000390	E84	1	—	—	—	—	1
Non-small-cell lung carcinoma	D002289	—	—	1	—	—	—	—	1
Lung neoplasms	D008175	—	C34.90	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Death	D003643	PATO_0001422	—	—	—	—	—	2	2
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	—	—	—	1	1
Renal insufficiency	D051437	—	N19	—	—	—	—	1	1
Mycoses	D009181	—	B35-B49	—	—	—	—	1	1
Myelodysplastic syndromes	D009190	—	D46	—	—	—	—	1	1
Myeloid leukemia acute	D015470	—	C92.0	—	—	—	—	1	1
Hematologic neoplasms	D019337	—	—	—	—	—	—	1	1
Recurrence	D012008	—	—	—	—	—	—	1	1
Myeloproliferative disorders	D009196	—	D47.1	—	—	—	—	1	1
Extranodal nk-t-cell lymphoma	D054391	—	C86.0	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Valganciclovir
INN	valganciclovir
Description	Valganciclovir is the L-valinyl ester of ganciclovir, into which it is rapidly converted by intestinal and hepatic esterases. It is a synthetic analogue of 2'-deoxyguanosine. It has a role as a prodrug and an antiviral drug. It is a member of purines and a L-valyl ester. It is functionally related to a guanine and a ganciclovir.
Classification	Small molecule
Drug class	antivirals: antivirals (acyclovir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)[C@H](N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21