CYTOVENE

LOE ApproachingSM

ganciclovir

Roche

NDAORALCAPSULEPriority Review

Approved

Dec 1994

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

Priority Review

CYTOVENE (ganciclovir) by Roche is [see microbiology ()] . Approved for cytomegalovirus retinitis, hiv infections, cytomegalovirus infections and 3 more indications. First approved in 1994.

Drug data last refreshed 19h ago

Mechanism of Action

[see Microbiology ()] .

Indications (6)

Cytomegalovirus Retinitis(14)HIV Infections(19)Cytomegalovirus Infections

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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.

Clinical Trials (20)

NCT00002095N/ACompleted

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

700 enrolled

Cytomegalovirus InfectionsHIV Infections

NCT00000856Phase 1Withdrawn

A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.

EncephalopathyHIV InfectionsRadiculitis

NCT00000697Phase 2Withdrawn

A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir

Cytomegalovirus RetinitisHIV Infections

NCT00002299N/ACompleted

The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Cytomegalovirus RetinitisHIV Infections

NCT00002247N/ACompleted

A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

225 enrolled

Cytomegalovirus RetinitisHIV Infections