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AboutPricing
Drug ReportsValacyclovir
Valacyclovir
Valacyclovir, Valtrex (valacyclovir) is a small molecule pharmaceutical. Valacyclovir was first approved as Valtrex on 1995-06-23. It is used to treat chickenpox, herpes genitalis, herpes labialis, herpes simplex, and herpes zoster in the USA.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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
infectionsD007239
stomatognathic diseasesD009057
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Valacyclovir, Valtrex (discontinued: Valacyclovir)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Valacyclovir hydrochloride
Tradename
Company
Number
Date
Products
VALTREXGSKN-020487 RX1995-06-23
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
acyclovir valacyclovir valacyclovir hydrochlorideANDA2023-06-29
direct rxANDA2015-11-09
valacyclovirANDA2025-10-28
valacyclovir hydrochlorideANDA2025-10-30
valacyclovir valacyclovirANDA2025-10-15
valacyclovir valacyclovir hydrochlorideANDA2020-06-17
valtrexNew Drug Application2025-06-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
herpes zosterEFO_0006510D006562B02
herpes simplexā€”D006561B00
herpes labialisEFO_1001347D006560B00.1
herpes genitalisEFO_0007282D006558A60
chickenpoxEFO_0007204D002644B01
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
ā€” J05: Antivirals for systemic use
ā€” J05A: Direct acting antivirals
ā€” J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
ā€” J05AB11: Valaciclovir
HCPCS
No data
Clinical
Clinical Trials
139 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
Herpes simplexD006561ā€”B001135ā€”10
Hiv infectionsD015658EFO_0000764B20ā€”ā€”2215
Herpes genitalisD006558EFO_0007282A60ā€”ā€”ā€”415
Herpes labialisD006560EFO_1001347B00.1ā€”1ā€”1ā€”2
Facial paralysisD005158ā€”G51.0ā€”ā€”ā€”1ā€”1
Bell palsyD020330EFO_0007167G51.0ā€”ā€”ā€”1ā€”1
Virus diseasesD014777ā€”B34ā€”ā€”ā€”1ā€”1
Herpesviridae infectionsD006566EFO_0007309B00.4ā€”ā€”ā€”1ā€”1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
ChickenpoxD002644EFO_0007204B01ā€”ā€”1ā€”12
Sexually transmitted diseasesD012749ā€”A50-A64ā€”ā€”2ā€”ā€”2
Herpes zosterD006562EFO_0006510B02ā€”ā€”1ā€”ā€”1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
Hepatitis cD006526ā€”B19.211ā€”ā€”ā€”2
Chronic hepatitis cD019698EFO_0004220B18.211ā€”ā€”ā€”2
Chronic hepatitis bD019694EFO_0004239B18.111ā€”ā€”ā€”2
HepatitisD006505ā€”K75.911ā€”ā€”ā€”2
Chronic hepatitisD006521ā€”K73.911ā€”ā€”ā€”2
Hepatitis aD006506EFO_0007305B1511ā€”ā€”ā€”2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
InfectionsD007239EFO_0000544ā€”1ā€”ā€”ā€”ā€”1
Communicable diseasesD003141ā€”ā€”1ā€”ā€”ā€”ā€”1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
RecurrenceD012008ā€”ā€”ā€”ā€”ā€”ā€”11
HivD006678ā€”O98.7ā€”ā€”ā€”ā€”11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameValacyclovir
INNvalaciclovir
Description
Valacyclovir is a L-valyl ester. It has a role as an antiviral drug. It is functionally related to a guanine.
Classification
Small molecule
Drug classantivirals: antivirals (acyclovir type)
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Structure (InChI/SMILES or Protein Sequence)
CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Identifiers
PDBā€”
CAS-ID124832-26-4
RxCUIā€”
ChEMBL IDCHEMBL1349
ChEBI ID35854
PubChem CID135398742
DrugBankDB00577
UNII IDMZ1IW7Q79D (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
ā‚¬
Ā£
ā‚£
No data
Estimated US medical usage
Valacyclovir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,445 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,981 adverse events reported
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