Drugs / 18F-Flutemetamol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Enrollment |
| 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 |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-06-24 | GE Healthcare | Regulatory FDA approves expanded indications for GE HealthCare’s Vizamyl PET imaging agent for beta amyloid detection, enabling more precise care for Alzheimer’s patients gehealthcare.com ↗
GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent VizamylTM (flutemetamol F 18 injection) for beta-amyloid detection. |
All press releases naming this drug 1 release
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-Flutemetamol | ClinicalTrials.gov intervention name — accepted as the source's own label 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 ↗ |