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Acyclovir
Sitavig, Xerese, Zovirax (acyclovir) is a small molecule pharmaceutical. Acyclovir was first approved as Zovirax on 1982-03-29. It is used to treat aids-related opportunistic infections, chickenpox, epstein-barr virus infections, herpes genitalis, and herpes labialis amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
nervous system diseasesD009422
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Sitavig, Zovirax (generic drugs available since 1997-04-22, discontinued: Avaclyr, Zovirax)
Combinations
Xerese
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acyclovir
Tradename
Company
Number
Date
Products
ZOVIRAXBausch Health CompaniesN-018604 RX1982-03-29
1 products, RLD, RS
ZOVIRAXBausch Health CompaniesN-021478 RX2002-12-30
1 products, RLD
SITAVIGNovanN-203791 RX2013-04-12
1 products, RLD, RS
Show 4 discontinued
Acyclovir
+
Hydrocortisone
Tradename
Company
Number
Date
Products
XERESEBausch Health CompaniesN-022436 RX2009-07-31
1 products, RLD, RS
Acyclovir sodium
Tradename
Company
Number
Date
Products
ZOVIRAXGSKN-018603 DISCN1982-10-22
3 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
acyclovirANDA2023-06-20
sitavigNew Drug Application2020-06-11
xereseNew Drug Application2020-08-03
zoviraxNew Drug Application2021-02-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aids-related opportunistic infections—D017088—
chickenpoxEFO_0007204D002644B01
epstein-barr virus infectionsEFO_0000769D020031—
herpes genitalisEFO_0007282D006558A60
herpes labialisEFO_1001347D006560B00.1
herpes simplex—D006561B00
herpes simplex encephalitis—D020803B00.4
herpes zosterEFO_0006510D006562B02
herpes zoster ophthalmicusEFO_0007403D006563B02.3
Agency Specific
FDA
EMA
Expiration
Code
ACYCLOVIR, AVACLYR, FERA PHARMS LLC
2026-03-29ODE-235
Patent Expiration
Patent
Expires
Flag
FDA Information
Acyclovir, Sitavig, Epi Hlth
85924342030-06-16DPU-1460
87478962027-06-03DPU-1460
87911272027-03-23DPU-1460
ATC Codes
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06B: Chemotherapeutics for topical use
— D06BB: Antivirals, topical
— D06BB03: Aciclovir
— D06BB53: Aciclovir, combinations
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
— J05AB01: Aciclovir
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AD: Antivirals, ophthalmologic
— S01AD03: Aciclovir
HCPCS
Code
Description
J0133
Injection, acyclovir, 5 mg
Clinical
Clinical Trials
112 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2026731329
Herpes simplexD006561B0014101417
Herpes labialisD006560EFO_1001347B00.11471—13
Herpes genitalisD006558EFO_0007282A60—235212
Herpetic keratitisD016849EFO_0007308——21—3
Healthy volunteers/patients—1——1—2
Herpes zosterD006562EFO_0006510B02——11—2
Relapsing-remitting multiple sclerosisD020529EFO_0003929———1—1
Viral pneumoniaD011024EFO_0007541J12.9———1—1
Papillomavirus infectionsD030361———1—1
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G353—1——4
UlcerD014456MPATH_579—21—13
InfectionsD007239EFO_0000544——1—12
ChickenpoxD002644EFO_0007204B01—11——2
Respiratory tract infectionsD012141J06.9——1——1
Covid-19D000086382U07.1——1——1
Meniere diseaseD008575EFO_0006862H81.0—11——1
Bone marrow transplantationD016026——1——1
CytomegalovirusD003587——1——1
CoinfectionD060085—11——1
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289—1———1
Large b-cell lymphoma diffuseD016403C83.311———1
Castration-resistant prostatic neoplasmsD064129—1———1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011———1
Biphenotypic leukemia acuteD015456C95.011———1
Philadelphia chromosomeD01067711———1
Kidney diseasesD007674EFO_0003086N0811———1
Kidney transplantationD01603011———1
Critical illnessD016638—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neonatal sepsisD000071074HP_00401871————1
SimplexvirusD0181391————1
HemorrhoidsD006484EFO_0009552K641————1
ObesityD009765EFO_0001073E66.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lymphatic diseasesD008206HP_0100763————33
Aseptic meningitisD008582EFO_1000823G03.0————11
Cerebral hemorrhageD002543————11
Subarachnoid hemorrhageD013345EFO_0000713I60————11
Drug monitoringD016903————11
Facial paralysisD005158G51.0————11
Molluscum contagiosumD008976EFO_0007375B08.1————11
UveitisD014605EFO_1001231H20.9————11
Acute kidney injuryD058186HP_0001919N17————11
Repeat cesarean sectionD017604————11
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameACYCLOVIR
INNaciclovir
Description
Acyclovir is an oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections. It has a role as an antiviral drug and an antimetabolite. It is an oxopurine and a member of 2-aminopurines. It is functionally related to a guanine.
Classification
Small molecule
Drug classantivirals: antivirals (acyclovir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Identifiers
PDB—
CAS-ID59277-89-3
RxCUI281
ChEMBL IDCHEMBL184
ChEBI ID2453
PubChem CID135398513
DrugBankDB00787
UNII IDX4HES1O11F (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 24,076 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,080 adverse events reported
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