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Neuraceq (florbetaben 18F)
Florbetaben 18F is a positron emission tomography (PET) imaging agent that binds to amyloid-beta plaques in the brain to detect Alzheimer's disease pathology.
Florbetaben 18F is a positron emission tomography (PET) imaging agent that binds to amyloid-beta plaques in the brain to detect Alzheimer's disease pathology. Used for Detection of cerebral amyloid-beta in patients with cognitive impairment or suspected Alzheimer's disease.
At a glance
| Generic name | Neuraceq (florbetaben 18F) |
|---|---|
| Also known as | FBB |
| Sponsor | Piramal Imaging Limited |
| Drug class | PET imaging agent |
| Target | Amyloid-beta plaques |
| Modality | Small molecule |
| Therapeutic area | Neurology / Diagnostic Imaging |
| Phase | FDA-approved |
Mechanism of action
Florbetaben is a fluorine-18 labeled benzofuran derivative that crosses the blood-brain barrier and selectively binds to amyloid-beta aggregates in the brain. The radioactive fluorine-18 isotope enables PET imaging to visualize and quantify amyloid burden, allowing clinicians to assess amyloid pathology in patients with cognitive impairment or suspected Alzheimer's disease.
Approved indications
- Detection of amyloid pathology in patients with cognitive impairment suspected to be due to Alzheimer's disease
Common side effects
- Injection site reactions
- Headache
- Dizziness
Key clinical trials
- Alzheimer's Disease Neuroimaging Initiative 4
- Longitudinal Early-onset Alzheimer's Disease Study Protocol
- Study of Biodistribution, Metabolism, Excretion and Brain Uptake 18F-JSS20-183A (EARLY_PHASE1)
- Test-retest Study With [18F]FBB in Cardiac Amyloidosis (PHASE1)
- Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (PHASE3)
- Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15 (EARLY_PHASE1)
- Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503 (EARLY_PHASE1)
- Imaging Inflammation in Alzheimer's Disease (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neuraceq (florbetaben 18F) CI brief — competitive landscape report
- Neuraceq (florbetaben 18F) updates RSS · CI watch RSS
- Piramal Imaging Limited portfolio CI