florbetapir

Trade name: Amyvid

Small moleculeapprovedImaging agent

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

Phase 1
23
Phase 2
28
Phase 3
8
Phase 4
9

Earliest trial started Jun 1, 2007 (NCT01565291)

Timeline

2000s

  1. Jan 1, 2007

    Avid Radiopharmaceuticals — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Avid Radiopharmaceuticals — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Avid Radiopharmaceuticals — Earliest Phase 3 Sponsor(trial)

2010s

  1. Apr 6, 2012

    Avid Radiopharmaceuticals — Earliest FDA Approval

  2. Apr 6, 2012

    Avid Radiopharmaceuticals — NDA Secondary Org

  3. Apr 6, 2012

    Avid Radiopharmaceuticals — NDA Organization

  4. Apr 6, 2012

    Eli Lilly — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedPriority reviewApr 6, 2012

Chemistry & pharmacology

Loading structure…

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

First in class

Sources

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 IDPhaseStart dateSponsor(s)
NCT06600880Phase 1Oct 1, 2024Columbia University
NCT05820191Phase 2Jul 31, 2024Universidad Central del Caribe, University of Puerto Rico
NCT05164536Phase 1Aug 27, 2021Invicro
NCT04390009Early Phase 1 (Phase 1)Mar 1, 2021Brain Health Alliance
NCT04118764N/AAug 6, 2020Columbia University, National Institute on Aging (NIA)
NCT04305210Phase 2Dec 1, 2019Chang Gung University
NCT03718494Phase 4Jun 30, 2019Columbia University, Harvard University, Mayo Clinic, National Institute on Aging (NIA), University of Arizona, University of California, San Francisco, Utah State University, Yale University
NCT04174287Phase 2Mar 28, 2019Chang Gung University
NCT03333551Phase 4Jan 31, 2019Medical College of Wisconsin
NCT04309253Phase 2Sep 21, 2018Chang Gung University
NCT03430869Phase 2Mar 23, 2018Chang Gung University
NCT04572477Phase 2Jun 1, 2017Chang Gung University
NCT03040713Phase 1Apr 11, 2017Avid Radiopharmaceuticals
NCT03019029Phase 1/Phase 2 (Phase 2)Mar 13, 2017Mayo Clinic
NCT03019536Phase 1Jan 31, 2017Eli Lilly
NCT03040427Phase 4Jan 1, 2017Avid Radiopharmaceuticals, The Cleveland Clinic, University of Rochester
NCT03058965Early Phase 1 (Phase 1)Nov 1, 2016Molecular NeuroImaging
NCT02667496Phase 2Nov 1, 2016National Institute on Aging (NIA), Sanofi
NCT02951598N/AOct 1, 2016Eli Lilly
NCT03080051Early Phase 1 (Phase 1)Aug 1, 2016Molecular NeuroImaging
Showing 20 of 73 trials
Page 1 / 4

Organizations

Research & Development (42)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Avid RadiopharmaceuticalsFor profit363252007
Chang Gung UniversityAcademic/Hospital9922009
Eli LillyFor profit6342011
Harvard UniversityAcademic/Hospital4332012
University of ToulouseAcademic/Hospital4432009
Columbia UniversityAcademic/Hospital3232019
Molecular NeuroImagingFor profit3312016
National Institute on Aging (NIA)Government3032016
General ElectricFor profit2022009
Mayo ClinicAcademic/Hospital2222017
National Institutes of Health (NIH)Government2022009
University of California, San FranciscoAcademic/Hospital2112012
American College of RadiologyAcademic/Hospital1012009
American Heart AssociationAcademic/Hospital1012016
BiogenFor profit1012012
Boston UniversityAcademic/Hospital1012015
Brain Health AllianceAcademic/Hospital1112021
Fondation Plan AlzheimerAcademic/Hospital1012014
François Rabelais UniversityAcademic/Hospital1012014
GenentechFor profit1112015
42 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
Avid RadiopharmaceuticalsFor profitNDA2Apr 6, 2012
Avid RadiopharmaceuticalsFor profitNDAApr 6, 2012
Eli LillyFor profitNDA2Apr 6, 2012