FLUORODOPA F18 (fluorodopa f-18)
Fluorodopa F 18 is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging. It is approved for the evaluation of adult patients with suspected Parkinsonian syndromes. The agent serves as a diagnostic adjunct to other clinical evaluations by visualizing dopaminergic nerve terminals in the striatum.
How FLUORODOPA F18 Works
Fluorodopa F 18 is an aromatic amino acid analog of L-DOPA that crosses the blood-brain barrier. It is taken up by presynaptic dopaminergic neurons in the striatum, where it is decarboxylated by the enzyme aromatic L-amino acid decarboxylase (AADC) into Fluorodopamine F 18. The resulting Fluorodopamine F 18 is then stored in presynaptic vesicles. PET imaging detects the positron emission from the F 18 isotope, allowing for the visualization and quantification of functional dopaminergic nerve terminals. In Parkinsonian syndromes, there is a characteristic loss of these dopaminergic neurons in the striatum.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-10
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FLUORODOPA F18 Approval History
What FLUORODOPA F18 Treats
1 indicationsFLUORODOPA F18 is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinsonian Syndromes
FLUORODOPA F18 Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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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.
FLUORODOPA F18 FDA Label Details
Indications & Usage
FDA Label (PDF)FLUORODOPA F18 is indicated for the treatment of Parkinsonian Syndromes.
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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