FLUCYTOSINE · NOVEL LABS INC
Flucytosine Capsules USP is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus . Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively.
Details
- Status
- Prescription
- First Approved
- 1971-11-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FLUCYTOSINE Approval History
What FLUCYTOSINE Treats
7 indicationsFLUCYTOSINE is approved for 7 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidiasis
- Cryptococcosis
- Septicemia
- Endocarditis
- Urinary Tract Infection
- Pulmonary Infection
- Meningitis
FLUCYTOSINE 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 Flucytosine Capsules USP....
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 Flucytosine Capsules USP.
FLUCYTOSINE 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 FLUCYTOSINE
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.
FLUCYTOSINE FDA Label Details
Indications & Usage
Flucytosine Capsules USP is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus . Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported. Flucytosine Capsules USP should be used in combination with amphotericin B for the trea...
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 Flucytosine Capsules USP....
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Full clinical data, patents, trials, and competitive landscape for flucytosine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.