Gadoteridol
As of the edition of 20 October 2026, Gadoteridol is a small molecule: marketed, first approved in 1992 (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 2011
- Kind
- Small molecule
- Brand name
- Prohance
- First approved
- 16 November 1992 (US)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- BRACCO IMAGING DO BRASIL IMPORTAÇÃO E DISTRIBUIÇÃO DE MEDICAMEN; 4 holders in all
- Registered trials
- 12, 1 stopped early
- Disease areas
- Nervous system; Cancer; Immune system; Digestive system; Heart and blood vessels; Hormones
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 | 4 | 3 | 0 | 0 |
| Phase 1 | 2 | 1 | 0 | 1 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bracco Diagnostics | Acquired holder and Lead sponsor of trials | 2003 to now |
| Bristol Myers Squibb | Originator | 1992 to 2003 |