VALACYCLOVIR HYDROCHLORIDE
Valacyclovir hydrochloride is an antiviral deoxynucleoside analogue used to treat infections caused by herpes viruses. In adults, it is indicated for cold sores (herpes labialis), shingles (herpes zoster), and the treatment, suppression, and reduction of transmission of genital herpes. In pediatric patients, it is indicated for cold sores and chickenpox (varicella). Usage in immunocompromised patients is limited; efficacy and safety have only been established for the suppression of genital herpes in HIV-1-infected patients and not for other indications in the immunocompromised population.
How VALACYCLOVIR HYDROCHLORIDE Works
Valacyclovir is a prodrug that is rapidly and nearly completely converted to acyclovir. Acyclovir is a deoxynucleoside analogue that selectively inhibits viral DNA polymerase. Once phosphorylated by viral thymidine kinase, it competes with deoxyguanosine triphosphate for viral DNA polymerase, leading to DNA chain termination. This process effectively blocks the replication of α-herpes viruses, including herpes simplex virus (HSV) and varicella-zoster virus (VZV).
Details
- Status
- Prescription
- First Approved
- 2007-01-31
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
VALACYCLOVIR HYDROCHLORIDE Approval History
What VALACYCLOVIR HYDROCHLORIDE Treats
6 indicationsVALACYCLOVIR HYDROCHLORIDE is approved for 6 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cold sores (Herpes labialis)
- Genital herpes
- Suppression of genital herpes
- Reduction of genital herpes transmission
- Herpes zoster (Shingles)
- Chickenpox
VALACYCLOVIR HYDROCHLORIDE 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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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.
VALACYCLOVIR HYDROCHLORIDE FDA Label Details
Indications & Usage
VALACYCLOVIR HYDROCHLORIDE is indicated for the treatment of Cold sores (Herpes labialis); Genital herpes; Suppression of genital herpes; Reduction of genital herpes transmission; Herpes zoster (Shingles); Chickenpox.
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Full clinical data, patents, trials, and competitive landscape for valacyclovir hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.