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
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 |
|---|---|---|---|---|
| DENAVIR | Mylan | N-020629 RX | 1996-09-24 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| denavir | New Drug Application | 2018-11-26 |
| penciclovir | NDA authorized generic | 2019-09-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epstein-barr virus infections | EFO_0000769 | D020031 | — |
| herpes labialis | EFO_1001347 | D006560 | B00.1 |
| herpesviridae infections | EFO_0007309 | D006566 | B00.4 |
Agency Specific
FDA
EMA
No data
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
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gout | D006073 | EFO_0004274 | M10 | — | 4 | 2 | 6 | — | 12 |
| Tumor lysis syndrome | D015275 | E88.3 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | — | — | — | 1 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Diabetes complications | D048909 | — | 1 | — | — | — | 1 | ||
| Hyperuricemia | D033461 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PENCICLOVIR |
| INN | penciclovir |
| Description | Penciclovir is a guanosine analogue antiviral drug used for the treatment of various herpesvirus infections. It is a nucleoside analogue which exhibits low toxicity and good selectivity. Because penciclovir is absorbed poorly when given orally (by mouth) it is more often used as a topical treatment. It is the active ingredient in the cold sore medications Denavir (NDC 0135-0315-52), Vectavir and Fenivir. Famciclovir is a prodrug of penciclovir with improved oral bioavailability.
|
| Classification | Small molecule |
| Drug class | antivirals: antivirals (acyclovir type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc(O)c2ncn(CCC(CO)CO)c2n1 |
Identifiers
| PDB | — |
| CAS-ID | 39809-25-1 |
| RxCUI | 59839 |
| ChEMBL ID | CHEMBL1540 |
| ChEBI ID | 7956 |
| PubChem CID | 4725 |
| DrugBank | DB00299 |
| UNII ID | 359HUE8FJC (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:
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Additional graphs summarizing 1,441 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,629 adverse events reported
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