NEURACEQ (florbetaben f-18)
NEURACEQ (florbetaben F-18) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment. It is used to assist in the evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and to identify patients who are candidates for amyloid beta-directed therapies.
How NEURACEQ Works
Florbetaben F-18 is a radiopharmaceutical that binds to β-amyloid plaques in the brain. The Fluorine-18 isotope decays by positron emission; the resulting photons (gamma rays) are detected by a PET scanner. The intensity of the signal correlates with the density of amyloid beta neuritic plaques in the brain, allowing for visual and quantitative assessment of plaque burden.
Details
- Status
- Prescription
- First Approved
- 2014-03-19
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
NEURACEQ Approval History
What NEURACEQ Treats
2 indicationsNEURACEQ is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's Disease
- Cognitive Decline
NEURACEQ Competitive Set
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Indication competitors
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Active Pipeline
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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.
NEURACEQ FDA Label Details
Indications & Usage
FDA Label (PDF)NEURACEQ is indicated for the treatment of Alzheimer's Disease; Cognitive Decline.
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Revenue Insights
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Patent Timeline
- • Cliff: 2032
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
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- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.