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ACYCLOVIR SODIUM
Acyclovir Sodium is a marketed antiviral drug primarily indicated for treating Herpes Simplex in immunocompromised patients. Its key strength lies in its established use and efficacy in this patient population, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent approaches expiration.
At a glance
| Generic name | ACYCLOVIR SODIUM |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Herpes Simplex in Immunocompromised Patients
- Severe Initial Herpes Genitalis
- Herpes Simplex Encephalitis
- Neonatal Herpes Infections
- Varicella-Zoster in Immunocompromised Patients
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
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)
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:
- ACYCLOVIR SODIUM CI brief — competitive landscape report
- ACYCLOVIR SODIUM updates RSS · CI watch RSS