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Placebo to VGCV
VGCV (valganciclovir) is a prodrug of ganciclovir that inhibits viral DNA polymerase to suppress cytomegalovirus (CMV) replication.
VGCV (valganciclovir) is a prodrug of ganciclovir that inhibits viral DNA polymerase to suppress cytomegalovirus (CMV) replication. Used for Cytomegalovirus (CMV) infection prophylaxis and treatment in immunocompromised patients.
At a glance
| Generic name | Placebo to VGCV |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Nucleoside analog antiviral |
| Target | CMV DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Valganciclovir is rapidly converted to ganciclovir in the body, where it is phosphorylated by viral kinases and incorporated into viral DNA, causing chain termination and inhibition of CMV DNA synthesis. This mechanism is selective for CMV-infected cells because the virus expresses the kinase necessary for initial phosphorylation.
Approved indications
- Cytomegalovirus (CMV) infection prophylaxis and treatment in immunocompromised patients
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Diarrhea
- Nausea
- Headache
Key clinical trials
- Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (PHASE2, PHASE3)
- Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections (PHASE3)
- ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION (PHASE1, PHASE2)
- Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss (PHASE2)
- Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) (PHASE3)
- A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants (PHASE3)
- Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers Against Human Herpes Virus 6 (HHV-6)and Epstein-Barr Virus (EBV) (PHASE1, PHASE2)
- A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF) (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |