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 5h ago · AI intelligence enriched 7h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZIRGAN is a topical ophthalmic gel containing ganciclovir, a nucleoside analog DNA polymerase inhibitor indicated for cytomegalovirus (CMV) infection of the eye. It works by inhibiting viral DNA synthesis, preventing CMV replication in ocular tissue. The product targets immunocompromised patients at risk for CMV keratitis.
$0.009BPart D
LOE ApproachingNiche specialty ophthalmic product with modest Medicare utilization and approaching loss of exclusivity, indicating a consolidating commercial footprint.
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)
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
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 Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Cytomegalovirus RetinitisHIV Infections
Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
240 enrolled
Cytomegalovirus RetinitisHIV Infections
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
48 enrolled
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.