Drugs / Gadopentetate dimeglumine
Gadopentetate dimeglumine
also known as
Magnevist · BAY86-4882 · gadopentate dimeglumine · SH L 451A · Acide gadopentetique · Acido gadopentetico · BAY86-6661 · Dimeglumine gadopentetate · +4 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | MAGNEVIST | — | 1989-04-28 – 1996-02-28 | fda.gov ↗ |
| Approved | US (FDA) | MAGNEVIST | — | 1988-06-02 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00310596 | Jan → Mar 2004 | — | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT01989195 | May → Jun 2013 | cardiomyopathy | Stanford University | Completed | Met primary |
| Phase 22 trials | ||||||
| Phase 2 | NCT00310544 | Mar → Sep 2006 | myocardial infarction | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00652418 | Jul → Oct 2004 | peripheral arterial disease | Bayer | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT00937391 | Jan → Sep 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00486473 | Jul 2007 → Dec 2009 | breast cancer | Bracco Diagnostics, Inc | Completed | Met primary |
| Phase 3 | NCT00395733 | Oct 2006 → Oct 2007 | vascular disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00310609 | Dec 2003 → Oct 2004 | congenital anomaly of cardiovascular system | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00310557 | Dec 2003 → Dec 2004 | renal artery obstruction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00309075 | Dec 2003 → Nov 2004 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00185276 | Mar 2003 → Aug 2004 | peripheral vascular disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00681551 | Feb 2003 → Mar 2004 | brain neoplasm | Bayer | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT02371798 | Feb 2015 → Nov 2016 | Meniere disease | Emory University | Withdrawn | No outcome recorded |
| — | NCT02080312 | Jan 2012 → Dec 2013 | Meniere disease | University of California, San Diego | Completed | No outcome recorded |
| — | NCT01416740 | Dec 2009 → Sep 2012 | — | Milton S. Hershey Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00677963 | Jun 2009 → Apr 2010 | atherosclerosis, carotid stenosis | Maastricht University Medical Center | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 0 | NCT01996527 Background | May 2012 → Nov 2015 | adult anaplastic ependymoma, adult glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma +2 | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00375830 Background | Jan 2006 → Apr 2017 | cancer | Stanford University | Completed | No outcome recorded |
| Phase 3 | NCT01211873 Comparator | Sep 2010 → Nov 2011 | central nervous system disorder | Guerbet | Completed | Met primary |
| Phase 3 | NCT01050829 Comparator | Jan 2010 → Apr 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01260636 Comparator | Sep 2009 → Dec 2011 | arterial disorder | Bracco Diagnostics, Inc | Completed | Met primary |
| Phase 3 | NCT00408083 Comparator | Dec 2006 → Nov 2008 | peripheral vascular disease | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00395460 Comparator | Sep 2006 → Apr 2007 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02175069 Background | Dec 2013 → Jul 2014 | — | Paracelsus Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01956409 Background | Sep 2012 → Dec 2016 | female breast carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00395863 Comparator | Nov 2006 → Feb 2008 | brain neoplasm | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| — | NCT02057874 Background | Feb 2014 → Nov 2015 | adult hepatocellular carcinoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded Stop: Business |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | gadopentetate dimeglumine | “the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg)” NCT02057874 ↗17“Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD)” NCT00395460 ↗ “Magnevist (Gadopentetate dimeglumine, BAY86-4882)” NCT00310544 ↗ “gadopentetate dimeglumine” NCT01996527 ↗ |
| Known as | Acide gadopentetique | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200431 ↗ |
| Known as | Acido gadopentetico | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200431 ↗ |
| Known as | BAY86-4882 | “Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)” NCT00652418 ↗5“Gadopentetate dimeglumine (Magnevist, BAY86-4882)” NCT00310596 ↗ “Gadopentetate Dimeglumine (Magnevist, BAY86-4882)” NCT01050829 ↗ “Gadopentetate dimeglumine (Magnevist, BAY86-4882)” NCT00185276 ↗ “Magnevist (Gadopentetate dimeglumine, BAY86-4882)” NCT00310544 ↗ “Gadopentate dimeglumine (Magnevist, BAY86-4882)” NCT00395733 ↗ |
| Known as | BAY86-6661 | “Gadopentetate dimeglumine (Magnevist, BAY86-6661)” NCT00937391 ↗ |
| Known as | Dimeglumine gadopentetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200431 ↗ |
| Known as | Gadopentate | “Gadopentate dimeglumine (Magnevist, BAY86-4882)” NCT00395733 ↗ |
| Known as | gadopentate dimeglumine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00677963 ↗ |
| Known as | Gadopentetic acid dimeglumine salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200431 ↗ |
| Known as | Magnevist | “Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day” NCT00309075 ↗17“CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)” NCT01989195 ↗ “Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)” NCT00652418 ↗ “Gadopentetate dimeglumine (Magnevist, BAY86-4882)” NCT00310596 ↗ “Gadopentetate dimeglumine (Magnevist, BAY86-4882)” NCT00185276 ↗ “Gadopentetate Dimeglumine (Magnevist, BAY86-4882)” NCT01050829 ↗ “Gadopentetate dimeglumine (Magnevist, BAY86-6661)” NCT00937391 ↗ “Gadopentate dimeglumine (Magnevist, BAY86-4882)” NCT00395733 ↗ “Gadopentetate dimeglumine (Magnevist)” NCT00310557 ↗ “Gadopentetate dimeglumine (Magnevist)” NCT00310609 ↗ |
| Known as | Magnevist Injection | “Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for...” NCT00310544 ↗ |
| Known as | Meglumine gadopentetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200431 ↗ |
| Known as | SH L 451A | “Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)” NCT00652418 ↗1“Magnevist (SH L 451A)” NCT00681551 ↗ |
| Modality | Diagnostic / imaging agent | “used for MRI of the infrarenal aorta and peripheral arteries” NCT00185276 ↗ |
| Route | Intravenous | “Single intravenous injection on the study day” NCT00185276 ↗ |