Gadobenate dimeglumine
As of the edition of 20 October 2026, Gadobenate dimeglumine is a small molecule: marketed, first approved in 1998 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Small molecule
- Brand name
- Multihance
- First approved
- 2 June 1998 (FR)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Bracco Diagnostics; 2 holders in all
- Registered trials
- 23, 6 stopped early
- Disease areas
- Cancer; Nervous system; Digestive system; Heart and blood vessels; Skin and connective tissue; Immune system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 6 | 0 | 3 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 4 | 2 | 1 | 1 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bracco Imaging | Applicant | 2004 to now |
| Bracco Diagnostics | Applicant and Lead sponsor of trials | 2004 to now |