Drugs / Gadoterate meglumine
Gadoterate meglumine
also known as
Dotarem · Dotarem (Gd-DOTA) contrast agent · Gadolinium DOTA Meglumine · Gd-DOTA · Gd-dota meglumine · Magnescope · Meglumine gadoterate · P 449
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DOTAREM | — | 2017-08-25 | fda.gov ↗ |
| Approved | US (FDA) | DOTAREM | — | 2013-03-20 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04341129 | Jul 2020 → Jun 2023 | breast cancer, breast fibroadenoma | University of Chicago | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01449266 | Nov 2011 → Mar 2012 | end stage renal failure | Guerbet | Completed | No outcome recorded |
| Phase 38 trials · 2 met primary | ||||||
| Phase 3 | NCT07348640 | Jul 2026 → Dec 2027 expected | arterial disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 3 | NCT05915728 | Jul 2023 → May 2024 | nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05915702 | Jul 2023 → May 2024 | central nervous system disorder | Bayer | Completed | Met primary |
| Phase 3 | NCT01211873 | Sep 2010 → Nov 2011 | central nervous system disorder | Guerbet | Completed | Met primary |
| Phase 3 | NCT01012674 | Oct 2009 → Dec 2010 | cerebral arterial disease | Guerbet | Completed | No outcome recorded |
| Phase 3 | NCT01010932 | Oct 2009 → Dec 2010 | cerebral arterial disease | Guerbet | Completed | No outcome recorded |
| Phase 3 | NCT00980681 | Sep 2009 → Dec 2010 | renal artery disease | Guerbet | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00845702 | Apr 2009 → Feb 2010 | renal artery disease | Guerbet | Terminated | No outcome recorded Stop: Enrollment |
| Phase 47 trials | ||||||
| Phase 4 | NCT02411201 | Mar → Oct 2015 | — | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT02034708 | Jun 2014 → Sep 2015 | primary brain neoplasm | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT02070380 | Feb 2014 → Mar 2015 | brain disorder | Bracco Diagnostics, Inc | Completed | Mixed |
| Phase 4 | NCT01806740 | May 2013 → Oct 2015 | hepatocellular carcinoma | Guerbet | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01254552 | Aug 2010 → Sep 2011 | coronary atherosclerosis, type 2 diabetes mellitus | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT01026389 | Oct 2009 → Jun 2011 | peripheral arterial disease | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT00650845 | Jan 2008 → May 2011 | chronic kidney disease | Guerbet | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03057561 | Oct 2016 → Dec 2020 | cardiomyopathy, coronary artery disorder | The Methodist Hospital Research Institute | Completed | No outcome recorded |
| — | NCT03000036 | Jul 2012 → Jan 2015 | doxorubicin induced cardiomyopathy, female breast carcinoma | University of Campinas, Brazil | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 0 | NCT02973633 Comparator | Jun 2017 → Dec 2027 expected | heart failure, myocardial infarction | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT02593370 Background | Oct → Nov 2015 | bone disorder | Thomas F. Bendtsen | Completed | No outcome recorded |
| Phase 2 | NCT07572383 Background | May 2026 → Dec 2028 expected | pulmonary fibrosis | Peter Caravan | Recruiting | No outcome recorded |
| Phase 2 | NCT06532071 Background | Jan 2025 → Dec 2028 expected | pulmonary fibrosis | Peter Caravan | Recruiting | No outcome recorded |
| Phase 2 | NCT05417776 Background | Sep 2022 → Oct 2026 expected | interstitial lung disease | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT02718976 Background | Mar → Apr 2016 | — | University of Aarhus | Completed | No outcome recorded |
| Phase 3 | NCT06057168 Comparator | Sep 2023 → Nov 2024 | brain cancer, primary brain neoplasm | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT04373564 Background | Mar 2021 → Dec 2028 expected | cognitive disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 4 | NCT03730051 Comparator | Mar 2021 → Dec 2025 | breast disorder | University of Massachusetts, Worcester | Completed | No outcome recorded |
| Phase 4 | NCT00764387 Comparator | Mar 2008 → May 2009 | central nervous system neoplasm | Bayer | Completed | No outcome recorded |
| — | NCT02364193 Background | Mar → Jun 2015 | pulmonary edema | Catharina Ziekenhuis Eindhoven | Completed | No outcome recorded |
Press releases naming this drug 2 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadoterate Meglumine | “Dotarem® (Gadoterate Meglumine)” NCT04341129 ↗ |
| Known as | Dotarem | “different doses of Gd-CA (Dotarem by Guerbet) ranging between 0.1 and 0.5 mmol will be injected intravenously” NCT02364193 ↗17“Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography” NCT07348640 ↗ “Drug: Gadoterate meglumine (Dotarem)” NCT00845702 ↗ “Dotarem” NCT04341129 ↗ |
| Known as | Dotarem (Gd-DOTA) contrast agent | “Dotarem (Gd-DOTA) contrast agent” NCT03057561 ↗ |
| Known as | Gadolinium DOTA Meglumine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02973633 ↗ |
| Known as | Gd-DOTA | “Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA)” NCT03057561 ↗ |
| Known as | Gd-dota meglumine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219415 ↗ |
| Known as | Magnescope | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219415 ↗ |
| Known as | Meglumine gadoterate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219415 ↗ |
| Known as | P 449 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219415 ↗ |
| Modality | Diagnostic / imaging agent | “in the diagnosis of clinically significant abdominal or lower limb arterial diseases” NCT01026389 ↗ |
| Route | Intravenous | “Single IV administration before MRI exam” NCT00650845 ↗ |