ANCOBON (flucytosine)
ANCOBON is indicated for the treatment of Candidiasis; Cryptococcosis; Septicemia; Endocarditis; Urinary Tract Infection; Pulmonary Infection; Meningitis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1971-11-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ANCOBON Approval History
What ANCOBON Treats
7 indicationsANCOBON is approved for 7 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidiasis
- Cryptococcosis
- Septicemia
- Endocarditis
- Urinary Tract Infection
- Pulmonary Infection
- Meningitis
ANCOBON Boxed Warning
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON....
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON.
ANCOBON 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 ANCOBON
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06414512 results posted | STUDY00017800 R01NS0863121 | Ph 2 | completed | Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis |
| NCT02015819 results posted | 13401 NCI-2013-02346, 13401 | Ph 1 | completed | Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas |
| NCT01172964 | 08002 NCI-2010-01388 | Ph 1 | completed | A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E.Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas |
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.
ANCOBON FDA Label Details
Indications & Usage
FDA Label (PDF)ANCOBON is indicated for the treatment of Candidiasis; Cryptococcosis; Septicemia; Endocarditis; Urinary Tract Infection; Pulmonary Infection; Meningitis.
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON....
Track ANCOBON with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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