Drugs / florbetapir F 18

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) AMYVID 2025-06-23 fda.gov
Approved EU (EMA) Amyvid 2013-01-14 europa.eu
Approved US (FDA) AMYVID 2012-04-06 fda.gov

Trials 34 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT04390009 Sep 2024 → Sep 2025 overdue multiple sclerosis Brain Health Alliance Recruiting No outcome recorded
Phase 0 NCT04926259 Nov 2021 → Dec 2024 neurodegenerative disease First Affiliated Hospital of Fujian Medical University Unknown No outcome recorded
Phase 0 NCT03080051 Aug 2016 → Mar 2017 Alzheimer disease, progressive supranuclear palsy Molecular NeuroImaging Completed No outcome recorded
Phase 0 NCT03071224 Jun 2016 → Jun 2021 Alzheimer disease Invicro Completed No outcome recorded
Phase 0 NCT01565291 Jun 2007 → Jan 2008 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 16 trials
Phase 1 NCT05164536 Aug 2021 → Nov 2022 Alzheimer disease Invicro Completed No outcome recorded
Phase 1 NCT02370524 Jan 2015 → Jan 2016 Alzheimer disease Molecular NeuroImaging Completed No outcome recorded
Phase 1 NCT01660815 Aug 2012 → Jan 2013 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 1 NCT01565343 Apr 2008 → Apr 2009 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 1 NCT01565330 Mar → Aug 2008 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 1 NCT01564706 Oct 2007 → Jan 2008 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01503944 Mar 2010 → Jul 2011 Alzheimer disease, Lewy body dementia, Parkinson disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 212 trials
Phase 2 NCT07012993 May 2025 → Jun 2030 expected Alzheimer disease, cognitive impairment with or without cerebellar ataxia Akiva Mintz Recruiting No outcome recorded
Phase 2 NCT05820191 Jul 2024 → Jul 2026 overdue glioblastoma Universidad Central del Caribe Not yet recruiting No outcome recorded
Phase 2 NCT04305210 Dec 2019 → Jan 2021 Alzheimer disease Chang Gung Memorial Hospital Unknown No outcome recorded
Phase 2 NCT04572477 Jun 2017 → Nov 2023 vascular dementia Chang Gung Memorial Hospital Unknown No outcome recorded
Phase 2 NCT02079766 Jun 2014 → Oct 2015 dementia pugilistica Avid Radiopharmaceuticals Completed No outcome recorded
Phase 2 NCT01518374 Dec 2009 → May 2017 Alzheimer disease, cognitive impairment with or without cerebellar ataxia Avid Radiopharmaceuticals Completed No outcome recorded
Phase 2 NCT01890343 Sep 2009 → Dec 2012 Alzheimer disease, frontotemporal dementia Avid Radiopharmaceuticals Completed No outcome recorded
Phase 2 NCT00855868 Mar 2009 → Jan 2011 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 2 NCT00857532 Jan 2009 → Nov 2011 Parkinson disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 2 NCT00857506 Jan 2009 → Dec 2011 Alzheimer disease, cognitive impairment with or without cerebellar ataxia Avid Radiopharmaceuticals Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01662882 Oct 2012 → Feb 2013 Alzheimer disease, cognitive impairment with or without cerebellar ataxia Avid Radiopharmaceuticals Completed No outcome recorded
Phase 33 trials
Phase 3 NCT04604587 Oct 2020 → Jul 2023 cerebral amyloid angiopathy, intracerebral hemorrhage National Taiwan University Hospital Unknown No outcome recorded
Phase 3 NCT01400425 Jul 2011 → Jul 2012 subjective cognitive decline Avid Radiopharmaceuticals Completed No outcome recorded
Phase 3 NCT00857415 Dec 2008 → Mar 2010 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 45 trials
Phase 4 NCT03040427 Jan 2017 → Aug 2019 amyloidosis The Cleveland Clinic Terminated No outcome recorded
Phase 4 NCT02051790 Mar → Aug 2014 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 4 NCT01683825 Mar 2013 → Oct 2018 amyloidosis Brigham and Women's Hospital Completed No outcome recorded
Phase 4 NCT01767493 Nov 2012 → Nov 2013 multiple sclerosis Institute for Neurodegenerative Disorders Completed No outcome recorded
Phase 4 NCT01703702 Oct 2012 → Apr 2015 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase not applicable1 trial
NCT01565356 Mar → May 2010 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04474405 Background Aug → Dec 2013 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 11 trial
Phase 1 NCT03019536 Background Jan 2017 → Jun 2019 Alzheimer disease Eli Lilly and Company Completed No outcome recorded
Phase 21 trial
Phase 2 NCT02051764 Background May 2014 → Dec 2016 Alzheimer disease Avid Radiopharmaceuticals Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT01565382 Background Feb 2011 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02107599 Background Mar → May 2014 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase 4 NCT01946243 Background Aug 2013 → Apr 2014 Alzheimer disease Avid Radiopharmaceuticals Completed No outcome recorded
Phase not applicable1 trial
NCT02029547 Background Oct 2014 → May 2015 Alzheimer disease Avid Radiopharmaceuticals Withdrawn No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 41 sources stand behind the page.

FieldValueCited text
Known as Florbetapir F-18 Florbetapir F-18 has been well tolerated in studies of more than 2000 human subjects.” NCT01683825
19

NCT02051790

NCT01565356

NCT01565382

NCT02051764

NCT01565291

NCT04474405

NCT00857415

NCT00702143

NCT01518374

NCT01946243

NCT01564706

NCT02079766

NCT01565330

NCT01565343

NCT00855868

NCT01400425

NCT03019536

NCT00857532

NCT00857506

Known as 18F-AV-45 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01503944
1

NCT04572477

Known as 18F-T807 “Dynamic PET imaging 3D acquisition will be acquired 80 minutes after injection of 10 mCi 18F-T807NCT04604587
2

NCT04926259

NCT02370524

Known as [123I]β-CIT ClinicalTrials.gov intervention name — accepted as the source's own label NCT00315250
Known as [18F]Florbetapir ClinicalTrials.gov intervention name — accepted as the source's own label NCT01767493
4

NCT04305210

NCT07012993

NCT03071224

NCT03080051

Known as Amyvid ClinicalTrials.gov intervention name — accepted as the source's own label NCT05164536
2

NCT04390009

NCT05820191

Known as AV-45 “18F-florbetapir (AV-45) PET Examination” NCT04305210
Known as F-18 labeled Florbetapir (Trade Name: Amyvid) F-18 labeled Florbetapir (Trade Name: Amyvid)NCT01683825
Known as F18-florbetapir “Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants” NCT04390009
2

NCT01683825

NCT03040427

Known as Florbetapir (18F) ClinicalTrials.gov intervention name — accepted as the source's own label NCT02029547
5

NCT01703702

NCT01660815

NCT01890343

NCT01662882

NCT02107599

Modality Diagnostic / imaging agent “positron emission tomography (PET) imaging” NCT00702143
Route Intravenous “IV injection, 370MBq (10mCi), single dose” NCT00702143