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Vizamyl (FLUTEMETAMOL)

Ge Healthcare · FDA-approved approved Small molecule Quality 50/100

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 nameFLUTEMETAMOL
SponsorGe Healthcare
Drug classRadioactive Diagnostic Agent [EPC]
ModalitySmall molecule
Therapeutic areaImmunology
PhaseFDA-approved
First approval2013

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

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity