Penciclovir
Denavir, Penciclovir (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
Therapeutic Areas
Trade Name
FDA
EMA
Denavir, Penciclovir
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| denavir | New Drug Application | 2018-11-26 |
| penciclovir | ANDA | 2024-10-02 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PENCICLOVIR, PENCICLOVIR, TORRENT | |||
| 2024-02-28 | CGT | ||
Patent Expiration
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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
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Clinical
Clinical Trials
13 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 labialis | D006560 | EFO_1001347 | B00.1 | — | — | 1 | 1 | — | 2 |
| Herpes simplex | D006561 | — | B00 | — | — | 1 | 1 | — | 2 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | — | 1 | — | 1 |
| Anaphylaxis | D000707 | — | T78.2 | — | — | — | 1 | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | — | 1 |
| Food hypersensitivity | D005512 | EFO_1001890 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 1 | — | — | 1 |
| Nasal obstruction | D015508 | — | — | — | — | 1 | — | — | 1 |
| Rhinorrhea | D000086722 | — | — | — | — | 1 | — | — | 1 |
| Sneezing | D012912 | EFO_0004290 | R06.7 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood pressure | D001794 | EFO_0004325 | — | 1 | 1 | — | — | — | 1 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | 1 | 1 | — | — | — | 1 |
| Heart rate | D006339 | EFO_0004326 | — | 1 | 1 | — | — | — | 1 |
| Herpetic stomatitis | D013283 | EFO_0007307 | — | — | 1 | — | — | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | 1 | — | — | — | 1 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | 1 | — | — | — | 1 |
| Hemophilia b | D002836 | — | D67 | — | 1 | — | — | — | 1 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Eczema | D004485 | — | L30.9 | — | — | — | — | 1 | 1 |
| Dermatitis | D003872 | — | L30.9 | — | — | — | — | 1 | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 1 | 1 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | — | — | 1 | 1 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | — | — | 1 | 1 |
| Right ventricular dysfunction | D018497 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Penciclovir |
| INN | penciclovir |
| 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 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 | — |
| ChEMBL ID | CHEMBL1540 |
| ChEBI ID | 7956 |
| PubChem CID | 135398748 |
| DrugBank | DB00299 |
| UNII ID | 359HUE8FJC (ChemIDplus, GSRS) |
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Estimated US medical usage
Penciclovir
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Trends
PubMed Central
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Additional graphs summarizing 1,883 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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196 adverse events reported
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