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Neuraceq (FLORBETABEN)
Neuraceq (generic name: FLORBETABEN) is a Radioactive Diagnostic Agent [EPC] Small molecule drug developed by Life Molecular. It is currently FDA-approved (first approved 2025) for Alzheimer’s disease, other causes of cognitive decline, Alzheimer’s disease.
Neuraceq (florbetaben) is a radioactive diagnostic agent used to visualize amyloid plaques in the brain, aiding in the diagnosis of Alzheimer's disease and other causes of cognitive decline. It is a small molecule that binds to amyloid beta peptides, allowing for imaging of these deposits. Neuraceq is a patented product, owned by Life Molecular, and was FDA-approved in 2025. Key safety considerations include its radioactive nature, requiring proper handling and disposal. It has a short half-life of 1 hour.
At a glance
| Generic name | FLORBETABEN |
|---|---|
| Sponsor | Life Molecular |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2025 |
Approved indications
- Alzheimer’s disease
- other causes of cognitive decline
- Alzheimer’s disease
- other causes of cognitive decline
Common side effects
- Injection site pain
- Injection site erythema
- Injection site irritation
Key clinical trials
- PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) (PHASE1)
- Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People (EARLY_PHASE1)
- Alzheimer's Disease Neuroimaging Initiative 4
- Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease
- 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)
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
- Life Molecular portfolio CI
Frequently asked questions about Neuraceq
What is Neuraceq?
What is Neuraceq used for?
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What is the generic name of Neuraceq?
What drug class is Neuraceq in?
When was Neuraceq approved?
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What are the side effects of Neuraceq?
Related
- Drug class: All Radioactive Diagnostic Agent [EPC] drugs
- Manufacturer: Life Molecular — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Alzheimer’s disease
- Indication: Drugs for other causes of cognitive decline
- Indication: Drugs for Alzheimer’s disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing