CYTOVENE

LOE ApproachingSM

ganciclovir

Roche
NDAORALCAPSULEPriority Review
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

[see Microbiology ()] .

Indications (4)

cytomegalovirus (CMV) retinitis in immunocompromised adult patientsCMV retinitis in immunocompromised adult patientsincluding patients with acquired immunodeficiency syndrome (AIDS)CMV disease in adult transplant recipients at risk for CMV disease

Clinical Trials (5)

NCT00002096Phase 1Completed

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

24 enrolled
Cytomegalovirus InfectionsHIV Infections
NCT00002134N/ACompleted

A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

450 enrolled
Cytomegalovirus RetinitisHIV Infections
NCT00002222N/ACompleted

A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS

200 enrolled
Cytomegalovirus RetinitisHIV Infections
NCT00017784Phase 3Unknown

Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection

500 enrolled
Cytomegalovirus RetinitisHIV Infections
NCT00002024N/ACompleted

Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

Cytomegalovirus InfectionsHIV Infections
Company
Roche
Roche
STAVANGER NORWAY, Norway
1128 open jobs
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers