Gadobutrol
As of the edition of 20 October 2026, Gadobutrol is a small molecule: marketed, first approved in 1998 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Gadavist
- First approved
- 26 February 1998 (CH)
- Approvals on record
- 11 in 6 regions
- Holder of the most recent approval
- Bayer; 2 holders in all
- Registered trials
- 57, 3 stopped early
- Disease areas
- Cancer; Nervous system; Heart and blood vessels; Urinary and reproductive; Skin and connective tissue; Digestive 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 | 18 | 11 | 4 | 1 |
| Phase 1 | 7 | 4 | 3 | 0 |
| Phase 2 | 5 | 3 | 0 | 2 |
| Phase 3 | 20 | 20 | 0 | 0 |
| Phase 4 | 7 | 5 | 2 | 0 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 1998 to now |