Last reviewed · How we verify
Valganciclovir CMV Prophylaxis
Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits cytomegalovirus (CMV) DNA polymerase to prevent viral replication.
Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits cytomegalovirus (CMV) DNA polymerase to prevent viral replication. Used for CMV prophylaxis in immunocompromised patients (e.g., post-transplant, HIV-positive).
At a glance
| Generic name | Valganciclovir CMV Prophylaxis |
|---|---|
| Also known as | Valcyte |
| Sponsor | University of California, San Francisco |
| 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 an L-valyl ester prodrug of ganciclovir that achieves higher oral bioavailability than ganciclovir alone. Once absorbed, it is rapidly converted to ganciclovir, which is phosphorylated by viral kinases and then inhibits CMV DNA polymerase, preventing viral DNA synthesis and replication. This mechanism makes it effective for CMV prophylaxis in immunocompromised patients.
Approved indications
- CMV prophylaxis in immunocompromised patients (e.g., post-transplant, HIV-positive)
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Diarrhea
- Nausea
- Headache
- Renal impairment
Key clinical trials
- Breakthrough CMV Lung Transplant -Multicentre
- Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients (PHASE4)
- Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients (PHASE3)
- Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
- Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV) (PHASE4)
- Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study (NA)
- Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients (PHASE4)
- Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney 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: