florbetapir
Trade name: Amyvid
Approved
Apr 6, 2012
Florbetapir (18F) (trade name AMYViD; also known as florbetapir-fluorine-18 or 18F-AV-45) is a PET scanning radiopharmaceutical compound containing the radionuclide fluorine-18, recently FDA approved as a diagnostic tool for Alzheimer's disease. Florbetapir, like Pittsburgh compound B (PiB), binds to beta-amyloid, however fluorine-18 has a half-life of 110 minutes, in contrast to PiB's radioactive half life of 20 minutes. Wong et al. found that the longer life allowed the tracer to accumulate significantly more in the brains of people with AD, particularly in the regions known to be associated with beta-amyloid deposits. A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvidis an adjunct to other diagnostic evaluations — NCATS
Clinical trial activity
73 trials · 42 clinical orgs · 2 marketing orgs
Earliest trial started Jun 1, 2007 (NCT01565291)
Timeline
2000s
- Jan 1, 2007
Avid Radiopharmaceuticals — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2008
Avid Radiopharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2008
Avid Radiopharmaceuticals — Earliest Phase 3 Sponsor(trial)
2010s
- Apr 6, 2012
Avid Radiopharmaceuticals — Earliest FDA Approval
- Apr 6, 2012
Avid Radiopharmaceuticals — NDA Secondary Org
- Apr 6, 2012
Avid Radiopharmaceuticals — NDA Organization
- Apr 6, 2012
Eli Lilly — NDA Secondary Org
Indications
Studied for
- Alzheimer Disease · Phase 4
- Amyloidosis · Phase 4
- Brain Injuries, Traumatic · Phase 2
- Chronic Traumatic Encephalopathy · Phase 2
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 2/Phase 3
- Corticobasal Degeneration · Phase 1
- Dementia · Phase 3
- Frontotemporal Dementia · Phase 2
- Glioblastoma · Phase 2
- Healthy Volunteers · Early Phase 1
- Lewy Body Disease · Phase 1/Phase 2
- Major Depressive Disorder · Phase 2
- Memory Disorders · Phase 1
- Multiple Sclerosis · Early Phase 1
- Neurodegenerative Diseases · Phase 2
- Parkinson Disease · Phase 2
- Postoperative Cognitive Complications · Phase 4
- Stroke · Phase 2
- Supranuclear Palsy, Progressive · Phase 1
Mechanism of action
- Amyloid beta A4 proteinBINDING AGENT
APP binding agent
- Unspecified targetOTHER
Diagnostic agent
Approval history
- approvedPriority reviewApr 6, 2012
Chemistry & pharmacology
SMILES
CNc1ccc(/C=C/c2ccc(OCCOCCOCCF)nc2)cc1- Mol. weight
- 360.43 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Imaging
- 18-fluorine
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL1908919 ↗
- WikipediaFlorbetapir (18F) ↗
- NCATS6W15Z5R0RU ↗
- ChEMBLCHEMBL1774461 ↗
Also known as
- 18f av45
- 18f av-45
- 18f av-45
- 18f-av-45
- 18f-av-45
- 18f-av-45
- [18f]florbetapir
- [18f]florbetapir
- 18f florbetapir
- 18f florbetapir
- 2-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)-5-(4-methylaminostyryl)pyridine
- 4-(2-(6-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)pyridin-3-yl)vinyl)-n-methylbenzamide
- 4-{(e)-2-[6-(2-{2-[2-(18f)fluoroethoxy]ethoxy}ethoxy)pyridin-3-yl]ethenyl}-n-methylaniline
- 4-{(e)-2-[6-(2-{2-[2-(18f)fluoroethoxy]ethoxy}ethoxy)pyridin-3-yl]ethenyl}-n-methylaniline
- amyvid
- amyvid
- amyvid
- amyvid
- amyvid
- av-45
- av-45
- florbetapir
- florbetapir
- florbetapir
- florbetapir
- florbetapir (18f)
- florbetapir (18f)
- florbetapir (18f)
- florbetapir (18f)
- florbetapir (18f)
- florbetapir f18
- florbetapir f18
- florbetapir f18
- florbetapir f 18
- florbetapir f 18
- florbetapir f 18
- florbetapir f 18
- florbetapir f 18
- florbetapir f 18
- florbetapir f-18
- florbetapir f-18
- florbetapir f-18
- florbetapir f-18
- florbetapir f-18
- florbetapir f 18 injection
- florbetapir-fluorine-18
- florbetapir-fluorine-18
- mni-798
- mni-952
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06600880 | Phase 1 | Oct 1, 2024 | Columbia University |
| NCT05820191 | Phase 2 | Jul 31, 2024 | Universidad Central del Caribe, University of Puerto Rico |
| NCT05164536 | Phase 1 | Aug 27, 2021 | Invicro |
| NCT04390009 | Early Phase 1 (Phase 1) | Mar 1, 2021 | Brain Health Alliance |
| NCT04118764 | N/A | Aug 6, 2020 | Columbia University, National Institute on Aging (NIA) |
| NCT04305210 | Phase 2 | Dec 1, 2019 | Chang Gung University |
| NCT03718494 | Phase 4 | Jun 30, 2019 | Columbia University, Harvard University, Mayo Clinic, National Institute on Aging (NIA), University of Arizona, University of California, San Francisco, Utah State University, Yale University |
| NCT04174287 | Phase 2 | Mar 28, 2019 | Chang Gung University |
| NCT03333551 | Phase 4 | Jan 31, 2019 | Medical College of Wisconsin |
| NCT04309253 | Phase 2 | Sep 21, 2018 | Chang Gung University |
| NCT03430869 | Phase 2 | Mar 23, 2018 | Chang Gung University |
| NCT04572477 | Phase 2 | Jun 1, 2017 | Chang Gung University |
| NCT03040713 | Phase 1 | Apr 11, 2017 | Avid Radiopharmaceuticals |
| NCT03019029 | Phase 1/Phase 2 (Phase 2) | Mar 13, 2017 | Mayo Clinic |
| NCT03019536 | Phase 1 | Jan 31, 2017 | Eli Lilly |
| NCT03040427 | Phase 4 | Jan 1, 2017 | Avid Radiopharmaceuticals, The Cleveland Clinic, University of Rochester |
| NCT03058965 | Early Phase 1 (Phase 1) | Nov 1, 2016 | Molecular NeuroImaging |
| NCT02667496 | Phase 2 | Nov 1, 2016 | National Institute on Aging (NIA), Sanofi |
| NCT02951598 | N/A | Oct 1, 2016 | Eli Lilly |
| NCT03080051 | Early Phase 1 (Phase 1) | Aug 1, 2016 | Molecular NeuroImaging |
Organizations
Research & Development (42)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Avid Radiopharmaceuticals | For profit | 36 | 32 | 5 | 2007 |
| Chang Gung University | Academic/Hospital | 9 | 9 | 2 | 2009 |
| Eli Lilly | For profit | 6 | 3 | 4 | 2011 |
| Harvard University | Academic/Hospital | 4 | 3 | 3 | 2012 |
| University of Toulouse | Academic/Hospital | 4 | 4 | 3 | 2009 |
| Columbia University | Academic/Hospital | 3 | 2 | 3 | 2019 |
| Molecular NeuroImaging | For profit | 3 | 3 | 1 | 2016 |
| National Institute on Aging (NIA) | Government | 3 | 0 | 3 | 2016 |
| General Electric | For profit | 2 | 0 | 2 | 2009 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 2 | 2017 |
| National Institutes of Health (NIH) | Government | 2 | 0 | 2 | 2009 |
| University of California, San Francisco | Academic/Hospital | 2 | 1 | 1 | 2012 |
| American College of Radiology | Academic/Hospital | 1 | 0 | 1 | 2009 |
| American Heart Association | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Biogen | For profit | 1 | 0 | 1 | 2012 |
| Boston University | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Brain Health Alliance | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Fondation Plan Alzheimer | Academic/Hospital | 1 | 0 | 1 | 2014 |
| François Rabelais University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Genentech | For profit | 1 | 1 | 1 | 2015 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Avid Radiopharmaceuticals | For profit | NDA2 | Apr 6, 2012 |
| Avid Radiopharmaceuticals | For profit | NDA | Apr 6, 2012 |
| Eli Lilly | For profit | NDA2 | Apr 6, 2012 |