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 22h ago · AI intelligence enriched 1mo 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)
An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
Cytomegalovirus RetinitisHIV Infections
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
48 enrolled
Cytomegalovirus RetinitisHIV Infections
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 I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
0
EncephalopathyHIV InfectionsRadiculitis
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
130 enrolled
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.