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Vizamyl (FLUTEMETAMOL)
Vizamyl works by binding to amyloid plaques in the brain, allowing for visualization through positron emission tomography (PET) imaging.
Vizamyl (flutemetamol) is a radioactive diagnostic agent used to help diagnose Alzheimer's disease and other causes of cognitive decline. It is a small molecule developed by GE Healthcare and approved by the FDA in 2013. Vizamyl is used to visualize amyloid plaques in the brain, which are a hallmark of Alzheimer's disease. The commercial status of Vizamyl is patented, and it is not yet available as a generic product. Key safety considerations include radiation exposure and potential allergic reactions.
At a glance
| Generic name | FLUTEMETAMOL |
|---|---|
| Sponsor | Ge Healthcare |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Flutemetamol F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. In in vitro binding studies using postmortem human brain homogenates containing fibrillar amyloid beta, the dissociation constant (Kd) for flutemetamol was 6.7 nM. Selectivity of 3 H-flutemetamol binding in postmortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to amyloid beta) correlation studies.
Approved indications
- Alzheimer's disease
- other causes of cognitive decline
- Alzheimer's disease
- other causes of cognitive decline
Common side effects
- Flushing
- Increased blood pressure
- Headache
- Nausea
- Dizziness
- Anaphylactic reactions
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
- Amyloid-β Clearance Mechanisms in Alzheimer's Disease
- Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol (PHASE2)
- Study of the Indications for Amyloid Positon Emission Tomography (PET) Scans and Their Usefulness for Patients With Suspected Alzheimer's Disease (AD)
- Brain Characterization of Amyloid Protein and Glucose Metabolism of ALFA Project Participants
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 |