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Denavir (PENCICLOVIR)
Denavir works by inhibiting the DNA polymerase enzyme of the herpes virus, preventing it from replicating and causing infection.
Denavir (Penciclovir) is a small molecule Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor developed by Denco Asset and currently owned by Mylan. It was FDA approved in 1996 for the treatment of Herpes labialis. Denavir is off-patent and has multiple generic manufacturers. It has a half-life of 2.1 hours and bioavailability of 77%. As an off-patent medication, Denavir is widely available in the market.
At a glance
| Generic name | PENCICLOVIR |
|---|---|
| Sponsor | Mylan |
| Drug class | Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1996 |
Mechanism of action
Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology (12.4)].
Approved indications
- Herpes labialis
Common side effects
- Application site reaction
- Hypesthesia/Local anesthesia
- Taste perversion
- Rash (erythematous)
Key clinical trials
- Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions (PHASE2)
- Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial. (PHASE4)
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- Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery
- Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects. (PHASE1)
- Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis (PHASE3)
- A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Denavir CI brief — competitive landscape report
- Denavir updates RSS · CI watch RSS
- Mylan portfolio CI