Drugs / Gadoxetate Disodium
Gadoxetate Disodium
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | EOVIST | — | 2015-03-27 | fda.gov ↗ |
| Approved | US (FDA) | EOVIST | — | 2008-07-03 | fda.gov ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03960788 | Jan 2018 → Jan 2020 | castration-resistant prostate carcinoma | University of Cincinnati | Unknown | No outcome recorded |
| Phase 0 | NCT01968629 | Dec 2013 → Jul 2015 | hepatocellular carcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02578602 | Oct 2010 → Nov 2014 | adult hepatocellular carcinoma | University of Southern California | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01420211 | Oct 2006 → Jul 2010 | liver disorder | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02084628 | Feb → Aug 2015 | — | Bayer | Terminated | No outcome recorded |
| Phase 3 | NCT00526188 | Aug 2007 → Aug 2008 | liver disorder | Bayer | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03215355 | Aug 2017 → Aug 2018 | liver cancer | Slawa Cwajna | Withdrawn | No outcome recorded |
| Phase 4 | NCT00908596 | May 2009 → Jul 2013 | — | Bayer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02156739 | Oct 2014 → Jun 2028 expected | hepatocellular carcinoma, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01867424 Comparator | May 2013 → May 2016 | prostate cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04373564 Background | Mar 2021 → Dec 2028 expected | cognitive disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 4 | NCT04288323 Background | Apr 2018 → Dec 2025 | carcinoma of liver and intrahepatic biliary tract, cirrhosis of liver | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT02431598 Comparator | Jun → Sep 2015 | — | Duke University | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | gadoxetate disodium | “Gadoxetate disodium (Gd-EOB-DTPA) (Eovist , Bayer HealthCare Pharmaceuticals Inc. Pittsburgh, PA) is an MR imaging agent which is FDA-approved gadolinium chelate for detecting...” NCT01867424 ↗6“the liver-specific MR imaging contrast agent gadoxetate disodium (Gd-EOB-DTPA) in Chinese patients” PMID 24322746 ↗ Dec 2013 |
| Known as | BAY86-4873 | “Gadoxetate disodium (Eovist/Primovist, BAY86-4873)” NCT02084628 ↗2“Gadoxetic acid disodium (Primovist, BAY86-4873)” NCT00908596 ↗ “Gadoxetic Acid Disodium (Primovist, BAY86-4873)” NCT00526188 ↗ |
| Known as | Eovist | “Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873)” NCT00908596 ↗ |
| Known as | gadolinium ethoxybenzyl dimeglumine | “This study will evaluate uptake of the hepatobiliary magnetic resonance imaging (MRI) contrast agent gadolinium ethoxybenzyl dimeglumine, or Eovist (Bayer Imaging, Wayne, NJ)” NCT01968629 ↗ |
| Known as | Gadolinium-ethoxybenzyl-diethylenetriamine-pentaacetic acid | “Gadolinium-ethoxybenzyl-diethylenetriamine-pentaacetic acid (Gadoxetate, Gd-EOB-DTPA, Primovist®) is a newly developed paramagnetic hepatobiliary contrast agent for magnetic...” NCT01420211 ↗ |
| Known as | Gadoxetate | “Gadolinium-ethoxybenzyl-diethylenetriamine-pentaacetic acid (Gadoxetate, Gd-EOB-DTPA, Primovist®) is a newly developed paramagnetic hepatobiliary contrast agent for magnetic...” NCT01420211 ↗ |
| Known as | Gadoxetate Sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03960788 ↗ |
| Known as | Gadoxetic acid disodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00908596 ↗ |
| Known as | Gd-EOB-DTPA | “Gadolinium-ethoxybenzyl-diethylenetriamine-pentaacetic acid (Gadoxetate, Gd-EOB-DTPA, Primovist®) is a newly developed paramagnetic hepatobiliary contrast agent for magnetic...” NCT01420211 ↗2“Gadoxetate disodium (Gd-EOB-DTPA) (Eovist , Bayer HealthCare Pharmaceuticals Inc. Pittsburgh, PA) is an MR imaging agent which is FDA-approved gadolinium chelate for detecting...” NCT01867424 ↗ “the liver-specific MR imaging contrast agent gadoxetate disodium (Gd-EOB-DTPA) in Chinese patients” PMID 24322746 ↗ Dec 2013 |
| Known as | Primovist | “Gadolinium-ethoxybenzyl-diethylenetriamine-pentaacetic acid (Gadoxetate, Gd-EOB-DTPA, Primovist®) is a newly developed paramagnetic hepatobiliary contrast agent for magnetic...” NCT01420211 ↗4“Gadoxetate disodium (Eovist/Primovist, BAY86-4873)” NCT02084628 ↗ “Gadoxetic acid disodium (Primovist, BAY86-4873)” NCT00908596 ↗ “Gadoxetic Acid Disodium (Primovist, BAY86-4873)” NCT00526188 ↗ |
| Modality | Diagnostic / imaging agent | “Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium.” NCT00526188 ↗ |
| Route | Intravenous | “after the intravenous administration of Primovist” NCT00526188 ↗ |