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 7h 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 Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir
30 enrolled
Cytomegalovirus RetinitisHIV Infections
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
48 enrolled
Cytomegalovirus RetinitisHIV Infections
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
The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV
850 enrolled
Cytomegalovirus RetinitisHIV InfectionsGastrointestinal Diseases
Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
500 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.