Drugs / 18F-Flutemetamol

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) VIZAMYL 2025-06-23 fda.gov
Approved US (FDA) VIZAMYL 2013-10-25 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03232632 Mar 2017 → Sep 2019 amyloidosis University Hospital, Toulouse Terminated No outcome recorded
Phase 25 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 NCT02317783 Jan 2018 → Sep 2019 breast cancer University of Utah Terminated No outcome recorded
Phase 2 NCT03068442 Feb 2017 → Sep 2030 expected arterial disorder, cognitive disorder Scott Mcnally Active not recruiting No outcome recorded
Phase 2 NCT02813070 Oct 2012 → May 2013 Alzheimer disease, cognitive impairment with or without cerebellar ataxia GE Healthcare Completed No outcome recorded
Phase 2 NCT01202994 May 2011 → May 2016 Alzheimer disease University of Utah Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03291093 Feb 2018 → Dec 2019 atherosclerosis Maastricht University Medical Center Unknown No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as [18F]Flutemetamol ClinicalTrials.gov intervention name — accepted as the source's own label NCT02317783
5

NCT01202994

NCT03291093

NCT03232632

NCT02813070

NCT07012993

Known as flutemetamol F 18 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03068442
Modality Diagnostic / imaging agent “Brain scan with imaging tracer that binds to amyloid plaques” NCT02317783
Route Intravenous “open-label intravenous (i.v.) administration of Flutemetamol F 18 Injection” NCT02813070