U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C13H20N6O4.ClH
Molecular Weight 360.797
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of VALACYCLOVIR HYDROCHLORIDE

SMILES

Cl.CC(C)[C@H](N)C(=O)OCCOCN1C=NC2=C1N=C(N)NC2=O

InChI

InChIKey=ZCDDBUOENGJMLV-QRPNPIFTSA-N
InChI=1S/C13H20N6O4.ClH/c1-7(2)8(14)12(21)23-4-3-22-6-19-5-16-9-10(19)17-13(15)18-11(9)20;/h5,7-8H,3-4,6,14H2,1-2H3,(H3,15,17,18,20);1H/t8-;/m0./s1

HIDE SMILES / InChI

Molecular Formula ClH
Molecular Weight 36.461
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Molecular Formula C13H20N6O4
Molecular Weight 324.3357
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 1 / 1
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment: description was created based on several sources, including https://clinicaltrials.gov/ct2/show/NCT01682109 | https://www.ncbi.nlm.nih.gov/pubmed/19957998 | https://www.ncbi.nlm.nih.gov/pubmed/7625798 | https://www.ncbi.nlm.nih.gov/pubmed/11454935

Valacyclovir is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir is a nucleoside analog DNA polymerase inhibitor. Valacyclovir hydrochloride is rapidly converted to acyclovir which has demonstrated antiviral activity against HSV types 1 (HSV-1) and 2 (HSV-2) and VZV both in cell culture and in vivo. The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analog. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In biochemical assays, acyclovir triphosphate inhibits replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. The resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of VZV with reduced susceptibility to acyclovir have been recovered from patients with AIDS. Valaciclovir is indicated for the treatment of HSV and VZV infections, including Oral and genital herpes simplex (treatment and prophylaxis), Reduction of HSV transmission from people with recurrent infection to uninfected individuals, Prevention of cytomegalovirus following organ transplantation, Prophylaxis against herpesviruses in immunocompromised patients (such as patients undergoing cancer chemotherapy). Common adverse drug reactions (≥1% of patients) associated with valaciclovir therapy are the same as for aciclovir, its active metabolite, and include nausea, vomiting, diarrhea, and headache. Infrequent adverse effects (0.1–1% of patients) include agitation, vertigo, confusion, dizziness, edema, arthralgia, sore throat, constipation, abdominal pain, rash, weakness and/or renal impairment. Rare adverse effects (<0.1% of patients) include coma, seizures, neutropenia, leukopenia, tremor, ataxia, encephalopathy, psychotic symptoms, crystalluria, anorexia, fatigue, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and/or anaphylaxis.

CNS Activity

Curator's Comment: Valacyclovir hydrochloride is rapidly converted to acyclovir which was detected in CSF after oral administration of valacyclovir.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
ZOVIRAX

Approved Use

Oral ZOVIRAX® (acyclovir) is indicated for the treatment: Herpes Zoster Infections: ZOVIRAX is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: ZOVIRAX is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: ZOVIRAX is indicated for the treatment of chickenpox (varicella). Injectable ZOVIRAX® (acyclovir) is indicated for the treatment: Herpes Simplex Infections in Immunocompromised Patients: ZOVIRAX for Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Initial Episodes of Herpes Genitalis: ZOVIRAX for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients. Herpes Simplex Encephalitis: ZOVIRAX for Injection is indicated for the treatment of herpessimplex encephalitis. Neonatal Herpes Simplex Virus Infection: ZOVIRAX for Injection is indicated for the treatmentof neonatal herpes infections. Varicella-Zoster Infections in Immunocompromised Patients: ZOVIRAX for Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.

Launch Date

3.86208006E11
Primary
ZOVIRAX

Approved Use

Oral ZOVIRAX® (acyclovir) is indicated for the treatment: Herpes Zoster Infections: ZOVIRAX is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: ZOVIRAX is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: ZOVIRAX is indicated for the treatment of chickenpox (varicella). Injectable ZOVIRAX® (acyclovir) is indicated for the treatment: Herpes Simplex Infections in Immunocompromised Patients: ZOVIRAX for Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Initial Episodes of Herpes Genitalis: ZOVIRAX for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients. Herpes Simplex Encephalitis: ZOVIRAX for Injection is indicated for the treatment of herpessimplex encephalitis. Neonatal Herpes Simplex Virus Infection: ZOVIRAX for Injection is indicated for the treatmentof neonatal herpes infections. Varicella-Zoster Infections in Immunocompromised Patients: ZOVIRAX for Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.

Launch Date

3.86208006E11
Primary
VALTREX

Approved Use

INDICATIONS AND USAGE. VALTREX is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis), Genital Herpes, Treatment in immunocompetent patients (initial or recurrent episode), Suppression in immunocompetent or HIV-infected patients, Reduction of transmission, Herpes Zoster. Pediatric Patients Cold Sores (Herpes Labialis), Chickenpox Limitations of Use. The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

Launch Date

1.07896321E12
Primary
VALTREX

Approved Use

INDICATIONS AND USAGE. VALTREX is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis), Genital Herpes, Treatment in immunocompetent patients (initial or recurrent episode), Suppression in immunocompetent or HIV-infected patients, Reduction of transmission, Herpes Zoster. Pediatric Patients Cold Sores (Herpes Labialis), Chickenpox Limitations of Use. The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

Launch Date

1.07887683E12
Primary
VALTRE

Approved Use

INDICATIONS AND USAGE. VALTREX is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis), Genital Herpes, Treatment in immunocompetent patients (initial or recurrent episode), Suppression in immunocompetent or HIV-infected patients, Reduction of transmission, Herpes Zoster. Pediatric Patients Cold Sores (Herpes Labialis), Chickenpox Limitations of Use. The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

Launch Date

1.07887683E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
599.2 ng/mL
400 mg single, oral
dose: 400 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ACYCLOVIR plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
3015.7 ng × h/mL
400 mg single, oral
dose: 400 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ACYCLOVIR plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
3.9 h
400 mg single, oral
dose: 400 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ACYCLOVIR plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
79%
ACYCLOVIR plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
Drug as perpetrator​Drug as victim
PubMed

PubMed

TitleDatePubMed
Hepatic and renal effects of azidothymidine and acyclovir on pregnant rats.
2000
Guanosine analogues as anti-herpesvirus agents.
2000 Oct-Dec
Flow cytometric evaluation of antiviral agents against human herpesvirus 6.
2001
Atypical Herpes simplex keratitis (HSK) presenting as a perforated corneal ulcer with a large infiltrate in a contact lens wearer: multinucleated giant cells in the Giemsa smear offered a clue to the diagnosis.
2001
A randomized, double-blind trial of famciclovir versus acyclovir for the treatment of localized dermatomal herpes zoster in immunocompromised patients.
2001
Interventions for herpes simplex virus epithelial keratitis.
2001
Prophylaxis against herpesvirus infections in transplant recipients.
2001
Recent advances in imaging endogenous or transferred gene expression utilizing radionuclide technologies in living subjects: applications to breast cancer.
2001
Heart transplantation and the Batista operation for children with refractory heart failure.
2001 Apr
Treatment of EBV driven lymphoproliferation with erythrophagocytosis: 12 year follow up.
2001 Apr
[Peptide transporter family].
2001 Apr
Biological characterization of eugeniin as an anti-herpes simplex virus type 1 compound in vitro and in vivo.
2001 Apr
Practice parameter: Steroids, acyclovir, and surgery for Bell's palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology.
2001 Apr 10
Hydrophilic interaction chromatography using amino and silica columns for the determination of polar pharmaceuticals and impurities.
2001 Apr 13
Postherpetic neuralgia. Pathogenesis of postherpetic neuralgia should be determined.
2001 Apr 7
[Photoallergy to Zovirax cream].
2001 Feb
Pretransplant varicella vaccination is cost-effective in pediatric renal transplantation.
2001 Feb
Genetic risks of antiviral nucleoside analogues--a survey.
2001 Feb
Viral etiologies of encephalitis in Thai children.
2001 Feb
Eczema herpeticum in parthenium dermatitis.
2001 Feb
Persistent verrucous varicella as the initial manifestation of HIV infection.
2001 Feb
Meta-analysis of prophylaxis of CMV disease in solid organ transplantation: is Ganciclovir a superior agent to Acyclovir?
2001 Feb-Mar
Prophylactic antiviral therapy in CMV high-risk liver transplant recipients.
2001 Feb-Mar
Recurrent herpes labialis: efficacy of topical therapy with penciclovir compared with acyclovir (aciclovir).
2001 Jan
Aerobic bacterial and fungal infections in peripheral blood stem cell transplants.
2001 Jan
[Valaciclovir in the treatment of initial infection by genital herpes virus: comparative study].
2001 Jan
Epstein-Barr virus-related lymphoproliferative disease complicating childhood acute lymphoblastic leukemia: no recurrence after unrelated donor bone marrow transplantation.
2001 Jan
Substantially improved in vivo radiosensitization of rat glioma with mutant HSV-TK and acyclovir.
2001 Jan
8-[18F]Fluoropenciclovir: an improved reporter probe for imaging HSV1-tk reporter gene expression in vivo using PET.
2001 Jan
Aseptic meningitis related to valacyclovir.
2001 Jan
Herpetic folliculitis and syringitis simulating acne excoriée.
2001 Jan
Management of the neonate whose mother received suppressive acyclovir therapy during late pregnancy.
2001 Jan
Successful outcome with a "quintuple approach" of posttransplant lymphoproliferative disorder.
2001 Jan 15
Virological, clinical, and ophthalmologic features of cytomegalovirus retinitis after hematopoietic stem cell transplantation.
2001 Jan 15
Novel synthesis of seco type of acyclo C-nucleosides of 1,2,4-triazole and 1,2,4-triazol.
2001 Jan-Feb
Neonatal herpes simplex and incontinentia pigmenti.
2001 Jan-Feb
Selection and characterization of varicella-zoster virus variants resistant to (R)-9-[4-hydroxy-2-(hydroxymethy)butyl]guanine.
2001 Jun
Mild herpes simplex encephalitis worsening despite acyclovir treatment.
2001 Mar
A pilot study of treatment of herpes labialis with 1072 nm narrow waveband light.
2001 Mar
[Neurologic toxicity caused by zelitrex (valaciclovir) in 3 patients with renal failure. Is overdose associated with improvement of product bioavailability improvement?].
2001 Mar
A 35-year-old man with recurrent aseptic meningitis.
2001 Mar
Predictors of recurrent herpes simplex virus keratitis. Herpetic Eye Disease Study Group.
2001 Mar
Long-term high-dose acyclovir and AIDS-related non-Hodgkins lymphoma.
2001 Mar 15
The management of varicella-zoster virus exposure and infection in pregnancy and the newborn period. Australasian Subgroup in Paediatric Infectious Diseases of the Australasian Society for Infectious Diseases.
2001 Mar 19
Neurotoxicity of valacyclovir in peritoneal dialysis: a pharmacokinetic study.
2001 Mar-Apr
Coexpression of guanylate kinase with thymidine kinase enhances prodrug cell killing in vitro and suppresses vascular smooth muscle cell proliferation in vivo.
2001 May
Oral recurrent human herpes virus infection and bone marrow transplantation survival.
2001 May
Chemical stability, enzymatic hydrolysis, and nasal uptake of amino acid ester prodrugs of acyclovir.
2001 May
Enhancement of the anti-herpetic effect of trichosanthin by acyclovir and interferon.
2001 May 11
Synthesis and biological evaluation of purine-containing butenolides.
2001 May 24
Patents

Sample Use Guides

Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
Route of Administration: Other
In Vitro Use Guide
Penciclovir (PCV) and acyclovir are acyclic guanine analogs which inhibit herpes simplex virus (HSV) DNA polymerase. Their 50% infective doses were 0.5 to 0.8 microgram/ml for clinical isolates of HSV-1 and 1.3 to 2.2 micrograms/ml for HSV-2.
Substance Class Chemical
Created
by admin
on Wed Jul 05 23:06:44 UTC 2023
Edited
by admin
on Wed Jul 05 23:06:44 UTC 2023
Record UNII
G447S0T1VC
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
VALACYCLOVIR HYDROCHLORIDE
MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF  
USAN  
Official Name English
VALACICLOVIR HYDROCHLORIDE [MART.]
Common Name English
L-VALINE, 2-((2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9-YL)METHOXY)ETHYL ESTER, MONOHYDROCHLORIDE
Common Name English
BW-256
Code English
VALTREX
Brand Name English
NSC-759101
Code English
VALACYCLOVIR HYDROCHLORIDE [USP MONOGRAPH]
Common Name English
L-VALINE, ESTER WITH 9-((2-HYDROXYETHOXY)METHYL)GUANINE, MONOHYDROCHLORIDE
Common Name English
VALACYCLOVIR HYDROCHLORIDE [ORANGE BOOK]
Common Name English
VALACYCLOVIR HYDROCHLORIDE [USAN]
Common Name English
VALACICLOVIR HYDROCHLORIDE [JAN]
Common Name English
VALACYCLOVIR HYDROCHLORIDE [MI]
Common Name English
VALACYCLOVIR HYDROCHLORIDE [VANDF]
Common Name English
Valaciclovir hydrochloride [WHO-DD]
Common Name English
256U
Code English
VALACYCLOVIR HYDROCHLORIDE [USP-RS]
Common Name English
VALACICLOVIR HYDROCHLORIDE ANHYDROUS
Common Name English
256-U-87 HYDROCHLORIDE
Code English
BW-256U87
Code English
VALACICLOVIR HYDROCHLORIDE
JAN   MART.   WHO-DD  
Common Name English
VALACYCLOVIR HCL
Common Name English
VALACICLOVIR (AS HYDROCHLORIDE)
Common Name English
256U87 HYDROCHLORIDE
Code English
VALACICLOVIR HYDROCHLORIDE [EP MONOGRAPH]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C281
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
NCI_THESAURUS C29575
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
NCI_THESAURUS C1556
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
Code System Code Type Description
FDA UNII
G447S0T1VC
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
SMS_ID
100000090390
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
NCI_THESAURUS
C29535
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
RS_ITEM_NUM
1707839
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
NSC
759101
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
MERCK INDEX
M11355
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY Merck Index
ChEMBL
CHEMBL1349
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
RXCUI
236081
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY RxNorm
CAS
124832-27-5
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
DRUG BANK
DBSALT000289
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
USAN
EE-13
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
PUBCHEM
135398741
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
DAILYMED
G447S0T1VC
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
EPA CompTox
DTXSID2044210
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
EVMPD
SUB15679MIG
Created by admin on Wed Jul 05 23:06:44 UTC 2023 , Edited by admin on Wed Jul 05 23:06:44 UTC 2023
PRIMARY
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