Drugs / Flutemetamol
Flutemetamol
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05374564 | Aug 2022 → Nov 2024 | cardiomyopathy | Yale University | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT02353949 | May 2015 → Dec 2019 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | University of Zurich | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02164643 | Jun 2014 → Oct 2019 | Alzheimer disease | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 3 | NCT01265394 | Dec 2010 → Mar 2011 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01165554 | May 2010 → Nov 2011 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01092546 | Mar 2010 → Apr 2011 | normal pressure hydrocephalus | GE Healthcare | Terminated | No outcome recorded |
| Phase 3 | NCT01028053 | Dec 2009 → Jan 2014 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01053312 | Dec 2009 → Jul 2010 | normal pressure hydrocephalus | GE Healthcare | Completed | 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 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flutemetamol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01165554 ↗ |
| Known as | [18F] Flutemetamol | “Drug: [18F] Flutemetamol” NCT01165554 ↗ |
| Known as | Flutemetamol (18F) | “Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.” NCT01165554 ↗1“Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.” NCT01265394 ↗ |
| Known as | flutemetamol F 18 | “Post-mortem histopathology underlying β-amyloid PET imaging following flutemetamol F 18 injection.” PMID 27955679 ↗ Dec 2016 |
| Known as | Vizamyl | “PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose” NCT02353949 ↗ |
| Modality | Diagnostic / imaging agent | “Flutemetamol (18F) Injection PET tracer” NCT01028053 ↗ |
| Route | Intravenous | “All subjects will receive an i.v. dose of (18F) flutemetamol” NCT01028053 ↗ |