Gadodiamide
As of the edition of 20 October 2026, Gadodiamide is a small molecule: marketed, first approved in 1993 (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 2012
- Kind
- Small molecule
- Brand name
- Omniscan
- First approved
- 8 January 1993 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA EQUIPAMENTOS M; 2 holders in all
- Registered trials
- 4, 0 stopped early
- Disease areas
- Urinary and reproductive; Chemically induced; Heart and blood vessels; Injuries; Pregnancy and women's health; Cancer
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 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GE Healthcare | Applicant and Lead sponsor of trials | 1993 to now |