flutemetamol F-18
Trade name: vizamyl
Small moleculeapprovedImaging agent
Approved
Oct 25, 2013
Flutemetamol F 18 is a radioactive molecular agent that is intended for use with PET imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia. Flutemetamol F 18 consists of flutemetamol, a thioflavin derivative of Pittsburgh compound B (PiB) labeled with the radioisotope fluorine F18 and it selectively binds to cerebral fibrillar beta-amyloid, a peptide involved in Alzheimer's disease. — NCATS
Clinical trial activity
17 trials · 17 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
13
Phase 3
9
Phase 4
0
Earliest trial started Sep 1, 2008 (NCT00785759)
Timeline
2000s
- Jan 1, 2008
General Electric — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2009
General Electric — Earliest Phase 3 Sponsor(trial)
2010s
- Oct 25, 2013
General Electric — Earliest FDA Approval
- Oct 25, 2013
General Electric — NDA Secondary Org
- Oct 25, 2013
General Electric — NDA Organization
- Jan 1, 2017
Earliest Phase 1 Sponsor(trial)
Indications
Studied for
- Alzheimer Disease · Phase 3
- Amyloidosis · Early Phase 1
- Atherosclerosis · Phase 2/Phase 3
- Brain Diseases · Phase 3
- Cardiomyopathies · Phase 1
- Carotid Stenosis · Phase 2
- Cognition Disorders · Phase 2
- Cognitive Dysfunction · Phase 3
- Dementia · Phase 3
- Healthy Volunteers · Phase 3
- Hydrocephalus, Normal Pressure · Phase 3
- Inflammation · Phase 2
Mechanism of action
- Amyloid beta A4 proteinBINDING AGENT
APP binding agent
- Unspecified targetOTHER
Diagnostic agent
Binds to β-amyloid plaques in the brain, used in PET scans
Approval history
- approvedOct 25, 2013
Chemistry & pharmacology
Loading structure…
SMILES
CNc1ccc(-c2nc3ccc(O)cc3s2)cc1F- Mol. weight
- 274.32 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
Sources
- ChEMBLCHEMBL579205 ↗
- WikipediaFlutemetamol (18F) ↗
- NCATSL49M066S0O ↗
- ChEMBLCHEMBL2042122 ↗
Also known as
- [18f]ah110690
- [18f]ah110690
- 18f flutametamol
- (18f)flutemetamol
- [18f]-flutemetamol
- [18f]-flutemetamol
- 18f flutemetamol
- 18f flutemetamol
- 18f-flutemetamol
- 18f-flutemetamol
- 18f-flutemetamol
- [18f]-flutemetamol f18
- [18f]-flutemetamol f18
- 2-[3-(18f)fluoro-4-(methylamino)phenyl]-1,3-benzothiazol-6-ol
- 2-[3-(18f)fluoro-4-(methylamino)phenyl]-1,3-benzothiazol-6-ol
- [3h]-flutemetamol
- [3h]-flutemetamol
- ah110690
- ah110690
- flutemetamol
- flutemetamol
- flutemetamol
- flutemetamol
- flutemetamol (18f)
- flutemetamol (18f)
- flutemetamol (18f)
- flutemetamol (18f)
- flutemetamol (18f)
- flutemetamol (18f)
- flutemetamol (18f)
- flutemetamol f18
- flutemetamol f18
- flutemetamol f18
- flutemetamol f18
- flutemetamol f 18
- flutemetamol f 18
- flutemetamol f 18
- flutemetamol f-18
- flutemetamol f-18
- flutemetamol f-18
- flutemetamol f-18
- flutemetamol f-18
- flutemetamol f 18 injection
- flutemetamol f 18 injection
- flutemetamol f 18 injection
- vizamyl
- vizamyl
- vizamyl
- vizamyl
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05374564 | Phase 1 | Aug 16, 2022 | Yale University |
| NCT03291093 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2018 | Maastricht University |
| NCT03232632 | Early Phase 1 (Phase 1) | Mar 15, 2017 | University of Toulouse |
| NCT03068442 | Phase 2 | Feb 17, 2017 | American Heart Association, University of Utah |
| NCT02317783 | N/A | Dec 1, 2015 | University of Utah |
| NCT02353949 | Phase 3 | May 1, 2015 | University of Zurich |
| NCT02164643 | Phase 3 | Jun 1, 2014 | Avid Radiopharmaceuticals, Fondation Plan Alzheimer, General Electric, University of Bordeaux, University of Lille |
| NCT02813070 | Phase 2 | Oct 1, 2012 | General Electric |
| NCT01672827 | Phase 3 | Jul 1, 2012 | General Electric |
| NCT01607476 | Phase 2 | Jul 1, 2012 | Mayo Clinic |
| NCT01202994 | Phase 2 | May 1, 2011 | University of Utah |
| NCT01265394 | Phase 3 | Dec 1, 2010 | General Electric, Medpace, Inc., Optum |
| NCT01165554 | Phase 3 | May 1, 2010 | Covance, General Electric, Optum |
| NCT01092546 | Phase 3 | Mar 1, 2010 | General Electric, Optum |
| NCT01053312 | Phase 3 | Dec 1, 2009 | General Electric, Optum |
| NCT01028053 | Phase 3 | Dec 1, 2009 | General Electric, IQVIA, Medpace, Inc., Optum |
| NCT00785759 | Phase 2 | Sep 1, 2008 | General Electric, Medpace, Inc., Optum, University of Copenhagen |
Showing 17 of 17 trials
Page 1 / 1
Organizations
Research & Development (17)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| General Electric | For profit | 9 | 8 | 2 | 2008 |
| Optum | For profit | 6 | 0 | 2 | 2008 |
| Medpace, Inc. | For profit | 3 | 0 | 2 | 2008 |
| University of Utah | Academic/Hospital | 3 | 3 | 2 | 2011 |
| American Heart Association | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Avid Radiopharmaceuticals | For profit | 1 | 0 | 1 | 2014 |
| Covance | For profit | 1 | 0 | 1 | 2010 |
| Fondation Plan Alzheimer | Academic/Hospital | 1 | 0 | 1 | 2014 |
| IQVIA | For profit | 1 | 0 | 1 | 2009 |
| Maastricht University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2012 |
| University of Bordeaux | Academic/Hospital | 1 | 1 | 1 | 2014 |
| University of Copenhagen | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Lille | Academic/Hospital | 1 | 0 | 1 | 2014 |
| University of Toulouse | Academic/Hospital | 1 | 1 | 1 | 2017 |
| University of Zurich | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Yale University | Academic/Hospital | 1 | 1 | 1 | 2022 |
17 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| General Electric | For profit | NDA2 | Oct 25, 2013 |
| General Electric | For profit | NDA | Oct 25, 2013 |