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Neuraceq (FLORBETABEN F18)
Neuraceq (Florbetaben F18) is a radioactive diagnostic agent developed by Piramal Imaging for positron emission tomography (PET) imaging. It targets the amyloid beta A4 protein, which is associated with Alzheimer's disease. Neuraceq is used to visualize amyloid plaques in the brain, helping diagnose Alzheimer's disease. The commercial status of Neuraceq is patented, and it was FDA-approved in 2014. Key safety considerations include radiation exposure and potential allergic reactions.
At a glance
| Generic name | FLORBETABEN F18 |
|---|---|
| Sponsor | Piramal Imaging |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Target | Amyloid beta A4 protein |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2014 |
Approved indications
- Positron emission tomography
Common side effects
- Injection site pain
- Injection site irritation
- Injection site erythema
Key clinical trials
- Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People (EARLY_PHASE1)
- PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) (PHASE1)
- Alzheimer's Disease Neuroimaging Initiative 4
- Longitudinal Early-onset Alzheimer's Disease Study Protocol
- PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease (PHASE1)
- 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neuraceq CI brief — competitive landscape report
- Neuraceq updates RSS · CI watch RSS
- Piramal Imaging portfolio CI