gadoversetamide
Trade name: optimark
Small moleculeapproved
Approved
Dec 8, 1999
Gadoversetamide is a gadolinium-based MRI contrast agent, particularly for imaging of the brain, spine and liver. It is marketed under the trade name OptiMARK. — Wikipedia
Clinical trial activity
3 trials · 4 clinical orgs · 3 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
0
Phase 4
1
Earliest trial started May 1, 2002 (NCT01092754)
Timeline
1990s
- Dec 8, 1999
Mallinckrodt — Earliest FDA Approval
- Dec 8, 1999
Liebel-Flarsheim — NDA Secondary Org
- Dec 8, 1999
Mallinckrodt — NDA Organization
- Dec 8, 1999
International Minerals and Chemical Corporation — NDA Secondary Org
2000s
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Diagnostic agent
- contrast mediumRadiopaque
contrast medium radiopaque
Approval history
- approvedDec 8, 1999
Chemistry & pharmacology
- Mol. weight
- 661.77 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaGadoversetamide ↗
- ChEMBLCHEMBL1200457 ↗
Also known as
- gadoversetamid
- gadoversetamid
- gadoversetamida
- gadoversetamida
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamide
- gadoversetamidum
- gadoversetamidum
- mp 1177
- mp-1177
- mp-1177
- mp-1177
- optimark
- optimark
- optimark
- optimark
- optimark
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01949844 | N/A | May 1, 2012 | Astellas, Cedars-Sinai Medical Center |
| NCT00862459 | Phase 2 | Aug 1, 2005 | Bayer |
| NCT01092754 | Phase 4 | May 1, 2002 | Mallinckrodt |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Astellas | For profit | 1 | 0 | 1 | 2012 |
| Bayer | For profit | 1 | 1 | 1 | 2005 |
| Cedars-Sinai Medical Center | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Mallinckrodt | For profit | 1 | 1 | 1 | 2002 |
4 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| International Minerals and Chemical Corporation | For profit | NDA2 | Dec 8, 1999 |
| Liebel-Flarsheim | For profit | NDA2 | Dec 8, 1999 |
| Mallinckrodt | For profit | NDA | Dec 8, 1999 |