NDAORALTABLETPriority Review
Approved
Mar 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
VALCYTE (valganciclovir) by Hetero is dna polymerase inhibitors [moa]. First approved in 2001.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALCYTE (valganciclovir) is an oral antiviral nucleoside analog that inhibits viral DNA polymerase, used primarily to treat cytomegalovirus (CMV) infections in immunocompromised patients, particularly transplant recipients and those with HIV. It is the oral prodrug of ganciclovir, offering improved bioavailability compared to IV formulations. The drug works by being phosphorylated to its active form, which then inhibits viral DNA synthesis.
$0.318MPart D
LOE ApproachingWith LOE approaching and modest Part D spending of $318K in 2023, the VALCYTE brand team is likely in a maintenance or wind-down phase with limited growth opportunities and smaller commercial infrastructure.
Mechanism of Action
DNA Polymerase Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir (VGCV) and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma
Started Dec 2024
45 enrolled
Hepatocellular Carcinoma (HCC)
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma
Started Oct 2024
43 enrolled
Glioblastoma
Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
Started Nov 2023
70 enrolled
Transplant ComplicationCMV
Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.
Started Oct 2023
90 enrolled
Infections, Cytomegalovirus
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Started Sep 2023
30 enrolled
Kidney Transplant; ComplicationsCMV
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.