penciclovir
Trade name: denavir
Approved
Sep 24, 1996
Penciclovir (DENAVIR®) is a synthetic acyclic guanine derivative with antiviral activity, mainly used to treat infections from herpes simplex virus (HSV) types 1 and 2. In cells infected with HSV-1 or HSV-2, the viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted by cellular kinases to the active form penciclovir triphosphate. Biochemical studies demonstrate that penciclovir triphosphate inhibits HSV polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited. Famciclovir (FAMVIR®) is a prodrug form of penciclovir with improved oral bioavailability. — NCATS
Clinical trial activity
2 trials · 3 clinical orgs · 5 marketing orgs
Earliest trial started Dec 1, 2008 (NCT00820534)
Timeline
1990s
2010s
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
2020s
- Nov 9, 2022
Teva — Marketing Organization
- Aug 7, 2023
Torrent Pharmaceuticals Limited — Marketing Organization
- Sep 27, 2024
Padagis Us — Marketing Organization
- Aug 22, 2025
Amneal Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Human herpesvirus 1 DNA polymeraseINHIBITOR
Human herpesvirus 1 DNA polymerase inhibitor
Approval history
- approvedSep 24, 1996
Chemistry & pharmacology
SMILES
Nc1nc(O)c2ncn(CCC(CO)CO)c2n1- Mol. weight
- 253.26 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL1540 ↗
- WikipediaPenciclovir ↗
- NCATS359HUE8FJC ↗
- ChEMBLCHEMBL2079793 ↗
Also known as
- 9-[2-hydroxy-1-(hydroxymethyl)-ethoxymethyl]guanine
- 9-[2-hydroxy-1-(hydroxymethyl)-ethoxymethyl]guanine
- 9-(4-hydroxy-3-hydroxymethylbut-1-yl)guanine
- 9-(4-hydroxy-3-hydroxymethylbut-1-yl)-guanine
- 9-(4-hydroxy-3-hydroxymethylbut-1-yl)-guanine
- 9-[4-hydroxy-3-(hydroxymethyl)but-1-yl]guanine
- 9-[4-hydroxy-3-(hydroxymethyl)but-1-yl]guanine
- 9-(4-hydroxy-3-(hydroxymethyl)butyl)guanine
- 9-(4-hydroxy-3-(hydroxymethyl)butyl)guanine
- brl 39123
- brl-39123
- brl-39123
- brl-39123
- denavir
- denavir
- denavir
- denavir
- denavir
- fenistil
- novartis brand of penciclovir
- pcv
- pcv
- pe2
- pe2
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir
- penciclovir, monosodium salt
- penciclovir, monosodium salt, monohydrate
- penciclovir sodium
- penciclovirum
- penciclovirum
- penciclovir visfarm
- sb-ch brand of penciclovir
- vectavir
- vectavir
- vectavir
- visfarm brand of penciclovir
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01257074 | Phase 3 | Feb 1, 2012 | EMS S/A, Medcin Instituto da Pele |
| NCT00820534 | Phase 4 | Dec 1, 2008 | Novartis |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| EMS S/A | For profit | 1 | 1 | 1 | 2012 |
| Medcin Instituto da Pele | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Novartis | For profit | 1 | 1 | 1 | 2008 |
Marketing (7)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amneal Pharmaceuticals | For profit | MKTG | Aug 22, 2025 |
| Mylan | For profit | NDA2 | Sep 24, 1996 |
| Mylan | For profit | SYN | Sep 24, 1996 |
| Mylan | For profit | NDA | Sep 24, 1996 |
| Padagis Us | For profit | MKTG | Sep 27, 2024 |
| Teva | For profit | MKTG | Nov 9, 2022 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Aug 7, 2023 |