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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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Clinical
Drug
Target
Variants
Financial
Trends
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Events Timeline
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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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
valacyclovirANDA2026-08-28
valacyclovir hydrochlorideANDA2026-08-13
valacyclovir valacyclovirANDA2026-02-18
valacyclovir valacyclovir hydrochlorideANDA2020-06-17
valtrexNew Drug Application2026-07-16
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
— J05AB11: Valaciclovir
HCPCS
No data
Clinical
Clinical Trials
147 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 simplexD006561—B0091311101053
Herpes zosterD006562EFO_0006510B022543822
InfectionsD007239EFO_0000544—5354520
Hiv infectionsD015658EFO_0000764B201263618
Communicable diseasesD003141——5333517
Herpes genitalisD006558EFO_0007282A60—425415
Virus diseasesD014777—B342——428
Cytomegalovirus infectionsD003586EFO_0001062B25—32217
Varicella zoster virus infectionD000073618——1——124
Herpesviridae infectionsD006566EFO_0007309B00.4———134
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
Prostatic neoplasmsD011471—C61141——5
Non-small-cell lung carcinomaD002289———31——4
ChickenpoxD002644EFO_0007204B011—1—24
Postherpetic neuralgiaD051474———12—14
Acquired immunodeficiency syndromeD000163EFO_0000765B20——3——3
NeuralgiaD009437EFO_0009430——11—13
Cognitive dysfunctionD060825—G31.84—21——3
Alzheimer diseaseD000544EFO_0000249F03—21——3
HivD006678—O98.7——1—23
PeriodontitisD010518EFO_0000649K05.31—1—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
GlioblastomaD005909EFO_0000515—64———7
GliomaD005910EFO_0000520—41———5
Lung neoplasmsD008175—C34.9023———5
Epstein-barr virus infectionsD020031EFO_0000769——2——24
AstrocytomaD001254EFO_0000271—33———4
Hepatitis cD006526—B19.221———3
Chronic hepatitis cD019698EFO_0004220B18.221———3
HepatitisD006505—K75.921———3
Hepatitis aD006506EFO_0007305B1521———3
Head and neck neoplasmsD006258——11———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
Healthy volunteers/patients———8———311
MalnutritionD044342EFO_0008572E40-E462———13
Infectious pregnancy complicationsD011251——1————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Pleural effusionD010996—J901————1
MesotheliomaD008654—C451————1
Malignant pleural effusionD016066—J91.01————1
Hepatitis bD006509——1————1
CoinfectionD060085——1————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Show 8 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
PhĀ 1
PhĀ 2
PhĀ 3
PhĀ 4
Other
Total
ParalysisD010243——————22
Acne vulgarisD000152EFO_0003894L70————11
HypertrophyD006984EFO_0002460—————11
RecurrenceD012008——————11
Bacterial vaginosisD016585EFO_0003932—————11
Vaginal diseasesD014623——————11
Immunologic deficiency syndromesD007153—D84.9————11
OncogenesD009857——————11
ElectroacupunctureD015671——————11
Periapical periodontitisD010485EFO_1001391K04.5————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
PDB—
CAS-ID124832-26-4
RxCUI—
ChEMBL IDCHEMBL1349
ChEBI ID35854
PubChem CID135398742
DrugBankDB00577
UNII IDMZ1IW7Q79D (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
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 9,602 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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24,039 adverse events reported
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