PENCICLOVIR
Penciclovir is a topical cream used for recurrent cold sores, also known as herpes labialis. It helps patients who are 12 years of age or older manage these viral outbreaks. This medication is prescribed to address the symptoms and progression of the sores caused by the herpes virus.
How PENCICLOVIR Works
This medication works by targeting the DNA polymerase of the herpes simplex virus. As a deoxynucleoside analog, it inhibits this specific enzyme to interfere with the virus's ability to replicate. This action helps control the activity of alpha herpes viruses within the body.
Details
- Status
- Prescription
- First Approved
- 2022-11-09
- Routes
- TOPICAL
- Dosage Forms
- CREAM
PENCICLOVIR Approval History
What PENCICLOVIR Treats
1 indicationsPENCICLOVIR is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Herpes Labialis
PENCICLOVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00820534 results posted | FPP4-DE-401 | Ph 4 | completed | A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PENCICLOVIR FDA Label Details
Indications & Usage
PENCICLOVIR is indicated for the treatment of Herpes Labialis.
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DENAVIR
Full clinical data, patents, trials, and competitive landscape for penciclovir.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.