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Amyvid (FLORBETAPIR)
Amyvid (generic name: FLORBETAPIR) is a Radioactive Diagnostic Agent [EPC] Small molecule drug developed by Avid Radiopharms Inc. It is currently FDA-approved (first approved 2013) for Alzheimer's disease, other causes of cognitive decline, Alzheimer's disease.
Amyvid binds to beta-amyloid plaques in the brain, allowing for visualization of these plaques through PET imaging.
Amyvid is a small molecule diagnostic agent used to detect conditions such as Cardiac Amyloidosis, Alzheimer's Disease, and Mild Cognitive Impairment. It is labeled as F-18 florbetapir and is used in imaging studies to help diagnose these conditions.
At a glance
| Generic name | FLORBETAPIR |
|---|---|
| Sponsor | Avid Radiopharms Inc |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Florbetapir F 18 binds to amyloid beta plaques 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 amyloid beta plaques, the dissociation constant (Kd) for florbetapir was 3.7 ± 0.3 nM. The binding of florbetapir F 18 to amyloid beta aggregates was demonstrated in postmortem human brain sections using autoradiographic methods, thioflavin S and traditional silver staining correlation studies as well as immunohistochemistry (monoclonal antibody to amyloid beta) correlation studies. Florbetapir binding to tau protein and a battery of neuroreceptors was not detected in in vitro studies.
Approved indications
- Alzheimer's disease
- other causes of cognitive decline
- Alzheimer's disease
- other causes of cognitive decline
Common side effects
- Headache
- Musculoskeletal pain
- Blood pressure increased
- Nausea
- Fatigue
- Injection site reaction
- Anxiety
- Back pain
- Claustrophobia
- Dizziness
- Feeling cold
- Insomnia
Key clinical trials
- Alzheimer's Disease Neuroimaging Initiative 4
- Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis (PHASE1,PHASE2)
- Biomarker Exploration in Aging, Cognition and Neurodegeneration (PHASE3)
- Study to Understand Novel Biomarkers in Researching Dementia
- Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography (PHASE4)
- Molecular Imaging of Primary Amyloid Cardiomyopathy (NA)
- A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
- Aβ PET and Tau PET Imaging in the Diagnosis and Progression Assessment of Alzheimer's Disease (NA)
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:
- Amyvid CI brief — competitive landscape report
- Amyvid updates RSS · CI watch RSS
- Avid Radiopharms Inc portfolio CI
Frequently asked questions about Amyvid
What is Amyvid?
How does Amyvid work?
What is Amyvid used for?
Who makes Amyvid?
What is the generic name of Amyvid?
What drug class is Amyvid in?
When was Amyvid approved?
What development phase is Amyvid in?
What are the side effects of Amyvid?
Related
- Drug class: All Radioactive Diagnostic Agent [EPC] drugs
- Manufacturer: Avid Radiopharms Inc — full pipeline
- Therapeutic area: All drugs in Immunology
- 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