ZYMAXID (gatifloxacin)
ZYMAXID is indicated for the treatment of Bacterial Conjunctivitis.
How ZYMAXID Works
Gatifloxacin is a 8-methoxyfluoroquinolone antimicrobial. It exerts its action by inhibiting DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This inhibition leads to bacterial cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-05-18
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
ZYMAXID Approval History
What ZYMAXID Treats
1 indicationsZYMAXID is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Conjunctivitis
ZYMAXID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ZYMAXID
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00410891 results posted | 96803 (eProtocol 4384) | Ph 4 | completed | Topical Antibiotics and Intravitreous Injections |
| NCT01421693 | 03NP | Ph 4 | completed | Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever |
| NCT01330355 results posted | 646 | Ph 3 | terminated | Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis |
| NCT00824070 results posted | 575 | Ph 1 | completed | Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects |
| NCT00905762 | 608 | Ph 1 | completed | Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYMAXID FDA Label Details
Indications & Usage
FDA Label (PDF)ZYMAXID is indicated for the treatment of Bacterial Conjunctivitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment