VALTREX (valacyclovir hydrochloride) · GSK
Valtrex is an antiviral medication indicated for the treatment of cold sores (herpes labialis) in adults and pediatric patients (12 years and older) and chickenpox in pediatric patients (2 to <18 years). In adult patients, it is used to treat herpes zoster (shingles) and to manage genital herpes by treating initial or recurrent episodes, providing chronic suppressive therapy, and reducing the risk of transmission. Its efficacy and safety have not been established in immunocompromised patients, except for the suppression of genital herpes in HIV-1-infected adults.
How VALTREX Works
Valacyclovir is a deoxynucleoside analogue DNA polymerase inhibitor. As a prodrug, it is rapidly converted to acyclovir, which selectively inhibits viral DNA polymerase. This action interferes with the DNA replication of $\alpha$-herpes viruses (such as HSV and VZV), thereby preventing viral proliferation.
Details
- Status
- Prescription
- First Approved
- 1995-06-23
- Routes
- ORAL, Oral
- Dosage Forms
- TABLET, Tablet
VALTREX Approval History
What VALTREX Treats
4 indicationsVALTREX is approved for 4 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cold Sores
- Genital Herpes
- Herpes Zoster
- Chickenpox
VALTREX 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
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Key Completed Trials
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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.
VALTREX FDA Label Details
Indications & Usage
FDA Label (PDF)VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1−infected patients Reduction of transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis) Chickenpox Limitations of Use The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) VA...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.