Flutemetamol
As of the edition of 20 October 2026, Flutemetamol is a small molecule: marketed, first approved in 2013 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Vizamyl
- First approved
- 25 October 2013 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Nihon Medi-Physics; 3 holders in all
- Registered trials
- 17, 4 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Cancer; Inherited and neonatal; Nutrition and metabolism
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 3 | 1 | 1 | 1 |
| Phase 2 | 5 | 3 | 1 | 1 |
| Phase 3 | 8 | 6 | 0 | 2 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GE Healthcare | Originator and Lead sponsor of trials | 2009 to now |
| GE Healthcare | Applicant | 2014 to now |
| Nihon Medi-Physics | Applicant | 2017 to now |