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Vizamyl (Flutemetamol (18F))
Vizamyl (generic name: Flutemetamol (18F)) is a Radioactive Diagnostic Agent [EPC] Small molecule drug developed by GE HealthCare. It is currently FDA-approved (first approved 2013) for Positron emission tomography. Also known as: Flutemetamol, 18F.
Vizamyl works by binding to amyloid beta A4 protein in the brain, allowing for visualization of amyloid deposits in PET imaging.
Vizamyl (Flutemetamol (18F)) is a radioactive diagnostic agent developed by GE HEALTHCARE for positron emission tomography (PET) imaging. It targets the amyloid beta A4 protein, which is associated with Alzheimer's disease. Vizamyl is a small molecule modality that was FDA-approved in 2013 for its approved indications. The commercial status of Vizamyl is patented, and it is owned by GE HEALTHCARE. Key safety considerations include the radioactive nature of the agent, which requires proper handling and disposal.
At a glance
| Generic name | Flutemetamol (18F) |
|---|---|
| Also known as | Flutemetamol, 18F |
| Sponsor | GE HealthCare |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Target | Amyloid beta A4 protein |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Flutemetamol 18 binds to -amyloid plaques in the brain and the F-18 isotope produces positron signal that is detected by PET scanner. In in vitro binding studies using postmortem human brain homogenates containing fibrillar -amyloid, the dissociation constant (Kd) for flutemetamol was 6.7 nM.Selectivity of [3H]flutemetamol binding in post-mortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to -amyloid) correlation studies.
Approved indications
- Positron emission tomography
Common side effects
- Flushing
- Increased blood pressure
- Headache
- Nausea
- Dizziness
Key clinical trials
- Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease
- Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease (PHASE1)
- Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy (PHASE1)
- Activity of Cerebral Networks, Amyloid and Microglia in Aging and Alzheimer's Disease
- Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol (PHASE2)
- Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
- The Swedish BioFINDER 2 Study (NA)
- The Swedish BioFINDER - Preclinical AD Study
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:
- Vizamyl CI brief — competitive landscape report
- Vizamyl updates RSS · CI watch RSS
- GE HealthCare portfolio CI
Frequently asked questions about Vizamyl
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Related
- Drug class: All Radioactive Diagnostic Agent [EPC] drugs
- Target: All drugs targeting Amyloid beta A4 protein
- Manufacturer: GE HealthCare — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Positron emission tomography
- Also known as: Flutemetamol, 18F
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing