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Valganciclovir/Ganciclovir
Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits viral DNA polymerase to prevent cytomegalovirus (CMV) replication.
Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits viral DNA polymerase to prevent cytomegalovirus (CMV) replication. Used for CMV retinitis in immunocompromised patients (HIV/AIDS, transplant recipients), CMV prophylaxis in high-risk transplant recipients, CMV gastroenteritis and colitis in immunocompromised patients.
At a glance
| Generic name | Valganciclovir/Ganciclovir |
|---|---|
| Sponsor | University Health Network, Toronto |
| Drug class | Nucleoside analog antiviral |
| Target | Cytomegalovirus (CMV) DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Valganciclovir is rapidly hydrolyzed to ganciclovir in the intestinal wall and liver. Ganciclovir is phosphorylated by viral kinases (particularly CMV UL97 kinase) to form active triphosphate metabolites that inhibit CMV DNA polymerase, preventing viral DNA synthesis and replication. This selective mechanism exploits the presence of viral kinases in infected cells.
Approved indications
- CMV retinitis in immunocompromised patients (HIV/AIDS, transplant recipients)
- CMV prophylaxis in high-risk transplant recipients
- CMV gastroenteritis and colitis in immunocompromised patients
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Headache
- Diarrhea
- Nausea
- Renal impairment
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)
- Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors (PHASE1)
- Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) (PHASE2)
- Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (PHASE2, PHASE3)
- Evaluation of Long-term Efficacy of 4 to 6-month Course Antiviral Therapy for Neurodevelopmental Impairments Caused by Congenital Cytomegalovirus Infection (PHASE4)
- A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections (PHASE3)
- Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients (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 |
|---|---|
| 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:
- Valganciclovir/Ganciclovir CI brief — competitive landscape report
- Valganciclovir/Ganciclovir updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI