Gadoterate meglumine
As of the edition of 20 October 2026, Gadoterate meglumine 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 2016
- Kind
- Small molecule
- Brand name
- Dotarem
- First approved
- 20 March 2013 (US)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- Guerbet
- Registered trials
- 32, 5 stopped early
- Disease areas
- Nervous system; Cancer; Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Lungs and airways
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 | 8 | 7 | 0 | 1 |
| Phase 1 | 3 | 2 | 1 | 0 |
| Phase 2 | 4 | 0 | 3 | 1 |
| Phase 3 | 8 | 5 | 1 | 2 |
| Phase 4 | 9 | 7 | 1 | 1 |
| All trials | 32 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Guerbet | Originator and Lead sponsor of trials | 2008 to now |