NDAOPHTHALMICGEL
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ZIRGAN (ganciclovir) by Bausch + Lomb is dna polymerase inhibitors [moa]. First approved in 2009.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZIRGAN is a topical ophthalmic gel containing ganciclovir, a nucleoside analog DNA polymerase inhibitor used to treat acute herpetic keratitis (dendritic ulcer) caused by herpes simplex virus. It works by inhibiting viral DNA replication in infected corneal cells. The gel formulation allows direct delivery to the eye with high local concentration.
$0.009BPart D
LOE ApproachingAs a niche ophthalmic product approaching loss of exclusivity, the brand team is likely small and focused on defending market share against generics and managing transition planning.
Mechanism of Action
DNA Polymerase Inhibitors
Pharmacologic Class:
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
194 enrolled
Cytomegalovirus RetinitisHIV Infections
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
24 enrolled
ColitisHIV Infections
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
24 enrolled
Cytomegalovirus InfectionsHIV Infections
A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
156 enrolled
Cytomegalovirus RetinitisHIV Infections
A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir
0
Cytomegalovirus RetinitisHIV 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.