Gadoversetamide
As of the edition of 20 October 2026, Gadoversetamide is a small molecule: marketed, first approved in 1999 (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 1999
- Kind
- Small molecule
- Brand name
- Optimark
- First approved
- 8 December 1999 (US)
- Approvals on record
- 9 in 1 region
- Holder of the most recent approval
- Liebel-Flarsheim
- Withdrawn from market
- 25 July 2017 (in some regions)
- Registered trials
- 2, 0 stopped early
- Disease areas
- Heart and blood vessels
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 4 | 1 | 1 | 0 | 0 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Liebel-Flarsheim | Acquired holder | 2015 to now |
| Byk-Mallinckrodt CIL | Originator | 1999 to 2015 |