Drugs / Gadoversetamide
Gadoversetamide
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Optimark | — | 2017-07-25 | europa.eu ↗ |
| Approved | EU (EMA) | Optimark | — | 2007-07-23 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | OPTIMARK | — | 2003-01-31 – 2006-08-04 | fda.gov ↗ |
| Approved | US (FDA) | OPTIMARK | — | 1999-12-08 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00862459 | Aug 2005 → Mar 2007 | brain disorder, spinal cord disorder | Bayer | Completed | Mixed |
| Phase 41 trial | ||||||
| Phase 4 | NCT01092754 | May 2002 → Dec 2003 | — | Guerbet | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT01949844 Background | May 2014 → Jan 2017 | coronary artery disorder | Daniel S. Berman | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadoversetamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01092754 ↗ |
| Known as | Gadoversetamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200457 ↗ |
| Known as | MP-1177 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200457 ↗ |
| Known as | OptiMARK | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00862459 ↗ |
| Modality | Diagnostic / imaging agent | “the contrast agent, Optimark®” NCT01949844 ↗ |
| Route | Intravenous | “a bolus thru a peripheral IV line” NCT01092754 ↗ |