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VALACYCLOVIR
Valacyclovir is an antiviral drug that inhibits viral DNA polymerase to treat herpes simplex and varicella-zoster viruses.
At a glance
| Generic name | VALACYCLOVIR |
|---|---|
| Also known as | valaciclovir |
| Drug class | Nucleoside analogue |
| Target | Viral DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1995 |
Mechanism of action
Valacyclovir is a prodrug that is rapidly converted to acyclovir in the body. Acyclovir selectively inhibits viral DNA polymerase, which is essential for the replication of herpes viruses. By blocking this enzyme, acyclovir prevents the synthesis of viral DNA, thereby halting the viral replication process. This mechanism is highly selective for viral enzymes, minimizing effects on host cells.
Approved indications
- Cold Sores (Herpes Labialis) — any
- Genital Herpes (Initial Episode) — any
- Genital Herpes (Recurrent Episodes) — any
- Suppression of Genital Herpes — any
- Reduction of Transmission of Genital Herpes — any
- Herpes Zoster (Shingles) — any
- Chickenpox (Varicella) — any
Pipeline indications
- Congenital Cytomegalovirus Infection — Phase 3
- Mild Cognitive Impairment — Phase 2
- Alzheimer's Disease — Phase 2
Common side effects
- Headache
- Nausea
- Abdominal pain
- Dizziness
- Fatigue
- Rash
- Dysmenorrhea
- Depression
- Arthralgia
- Vomiting
- Nasopharyngitis
- Upper respiratory tract infection
Drug interactions
- None known
Key clinical trials
- A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec (PHASE2)
- Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors (PHASE1)
- Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia (PHASE2)
- Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma (PHASE1, PHASE2)
- Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) (PHASE2)
- Neonatal Phase 1 Valacyclovir Study (PHASE1)
- Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (PHASE3)
- Electroacupuncture Regulation of Immune Cells in Herpes Zoster (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VALACYCLOVIR CI brief — competitive landscape report
- VALACYCLOVIR updates RSS · CI watch RSS