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Drug ReportsPenciclovir
Penciclovir
Denavir (penciclovir) is a small molecule pharmaceutical. Penciclovir was first approved as Denavir on 1996-09-24. It is used to treat epstein-barr virus infections, herpes labialis, and herpesviridae infections 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
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Denavir (generic drugs available since 2022-11-09)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Penciclovir
Tradename
Company
Number
Date
Products
DENAVIRMylanN-020629 RX1996-09-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
denavirNew Drug Application2018-11-26
penciclovirANDA2024-10-02
Agency Specific
FDA
EMA
Expiration
Code
PENCICLOVIR, PENCICLOVIR, TORRENT
2024-02-28CGT
Patent Expiration
No data
ATC Codes
D: Dermatologicals
D06: Antibiotics and chemotherapeutics for dermatological use
D06B: Chemotherapeutics for topical use
D06BB: Antivirals, topical
D06BB06: Penciclovir
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB13: Penciclovir
HCPCS
No data
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Herpes labialisD006560EFO_1001347B00.11113
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Herpes simplexD006561B00112
Respiratory tract infectionsD012141J06.911
Nasal obstructionD015508HP_000174211
RhinorrheaD00008672211
SneezingD012912EFO_0004290R06.711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood pressureD001794EFO_0004325111
Cardiac arrhythmiasD001145EFO_0004269I49.9111
Heart rateD006339EFO_0004326111
Herpetic stomatitisD013283EFO_000730711
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L2011
EczemaD004485HP_0000964L30.911
DermatitisD003872HP_0011123L30.911
Post-traumatic stress disordersD013313EFO_0001358F43.111
Traumatic stress disordersD04092111
CataractD002386HP_0000518H26.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePenciclovir
INNpenciclovir
Description
Penciclovir is a member of the class of 2-aminopurines that is guanine in which the hydrogen at position 9 is substituted by a 4-hydroxy-3-(hydroxymethyl)but-1-yl group. An antiviral drug, it is administered topically for treatment of herpes labialis. A prodrug, famciclovir, is used for oral administration. It has a role as an antiviral drug. It is a member of 2-aminopurines and a member of propane-1,3-diols. 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)
Nc1nc(O)c2ncn(CCC(CO)CO)c2n1
Identifiers
PDB
CAS-ID39809-25-1
RxCUI
ChEMBL IDCHEMBL1540
ChEBI ID7956
PubChem CID135398748
DrugBankDB00299
UNII ID359HUE8FJC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Penciclovir
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 1,609 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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193 adverse events reported
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