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Zovirax (ACYCLOVIR)
Acyclovir works by mimicking a building block of DNA to prevent the herpes virus from replicating.
Zovirax (Acyclovir) is a small molecule drug developed by Valeant Bermuda and currently owned by Ligand Pharmaceuticals. It targets the enzyme purine nucleoside phosphorylase and works as a nucleoside analog DNA polymerase inhibitor to treat various herpes simplex virus infections. Zovirax has been FDA-approved since 1982 for multiple indications, including encephalitis, genital herpes, and herpes zoster. The drug has a bioavailability of 22% and a half-life of 2.5 hours. It is available as a generic medication from multiple manufacturers.
At a glance
| Generic name | ACYCLOVIR |
|---|---|
| Also known as | aciclovir |
| Sponsor | Ligand Pharms |
| Drug class | Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC] |
| Target | Purine nucleoside phosphorylase |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1982 |
Mechanism of action
Mechanism of Antiviral Action:. Acyclovir is synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types (HSV-1), (HSV-2), and varicella-zoster virus (VZV).The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK.
Approved indications
- Encephalitis due to Herpesvirus
- Genital herpes simplex
- Herpes labialis
- Herpes simplex
- Herpes simplex infection of skin
- Herpes zoster
- Recurrent Mucocutaneous Herpes Simplex
- Recurrent genital herpes simplex
- Recurrent herpes simplex labialis
- Suppression of Recurrent Herpes Simplex Infection
- Varicella
Common side effects
- Inflammation or phlebitis at the injection site
- Transient elevations of serum creatinine or BUN
- Nausea and/or vomiting
- Itching, rash, or hives
- Elevation of transaminases
- Anemia
- Neutropenia
- Thrombocytopenia
- Thrombocytosis
- Leukocytosis
- Neutrophilia
- Anorexia
Drug interactions
- fosphenytoin
- phenytoin
- rifampicin
- theophylline
- tizanidine
Key clinical trials
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (PHASE2)
- Impact of Obesity on Clinical Outcomes in Patients Receiving Acyclovir for HSV Encephalitis"
- A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec (PHASE2)
- Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors (PHASE1)
- 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)
- Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir (PHASE4)
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:
- Zovirax CI brief — competitive landscape report
- Zovirax updates RSS · CI watch RSS
- Ligand Pharms portfolio CI