Product Description
Florbetapir (18F) is a radiopharmaceutical compound containing the radionuclide fluorine-18 bound to the compound florbetapir, a molecule that binds with high affinity to beta amyloid plaque, a peptide that plays a key role in Alzheimer's Disease pathogenesis. Marketed as the product Amyvid, florbetapir 18F is indicated for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Florbetapir-_18F)
Mechanisms of Action: APP Imaging Agent
Novel Mechanism: No
Modality: Diagnostic Agent
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Italy | Japan | Latvia | Lithuania | Netherlands | Poland | Portugal | Slovakia | Spain | Sweden | Switzerland | United States
Approved Indications: Alzheimer Disease | Dementia
Known Adverse Events: Headache | Pain Unspecified | Musculoskeletal Pain | Pregnancy Outcomes
Company: Avid Radiopharmaceuticals
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Alzheimer Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CTR20221832 | P3 |
Completed |
Alzheimer Disease |
2023-03-20 |
|
| CTR20211942 | P1 |
Not yet recruiting |
Alzheimer Disease |
None |