Drugs / Gadoterate
Gadoterate
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02286258 | Oct 2014 → Feb 2017 | chronic kidney disease | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT03602339 | Nov 2018 → Mar 2020 | — | Bayer | Completed | Met primary |
| Phase 4 | NCT02382380 | Nov 2014 → Mar 2024 | impaired renal function disease | Loyola University | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-10-01 | Bayer | Results Bayer’s Gadovist™ (Gadobutrol) at a Reduced Dose Demonstrates Non-Inferiority Compared to a Standard Dose of Gadoterate for CNS Imaging bayer.com ↗
Bayer published today the results of its LEADER-75 (LowEr Administered Dose with highEr Relaxivity) study, demonstrating the clinical efficacy of a reduced dose of gadobutrol compared to a standard dose of gadoterate in patients undergoing a steady-state contrast-enhanced MRI of the CNS. |
| 2020-12-10 | GE Healthcare | Regulatory GE Healthcare Completes Portfolio of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) with U.S. FDA Approval of Clariscan in 5mL Glass Vials gehealthcare.com ↗
The U.S. FDA has approved 5mL glass vial packaging for Clariscan (gadoterate meglumine), completing its packaging portfolio. |
| 2020-09-15 | GE Healthcare | Regulatory GE Healthcare’s Clariscan™ (gadoterate meglumine) Becomes Only FDA-Approved MRI Contrast Agent Available in Polymer Bottle gehealthcare.com ↗
GE Healthcare’s innovative shatterproof polymer +PLUSPAK Pharmacy Bulk Package has been approved by the US FDA for use with its macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine). |
| 2019-11-04 | GE Healthcare | Regulatory GE Healthcare announces U.S. FDA approval of macrocyclic MRI contrast agent Clariscan™ (gadoterate meglumine) injection for intravenous use gehealthcare.com ↗
The U.S. Food and Drug Administration (FDA) has approved Clariscan™, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists. |
All press releases naming this drug 5 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadoterate | “Gadoterate” NCT03602339 ↗ |
| Known as | Clariscan | “Gadoterate (Dotarem/Clariscan)” NCT03602339 ↗ |
| Known as | Dotarem | “Gadoterate (Dotarem/Clariscan)” NCT03602339 ↗ |
| Known as | Gd-DOTA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02286258 ↗ |
| Modality | Diagnostic / imaging agent | “Gd-DOTA is a macrocyclic paramagnetic contrast product” NCT02286258 ↗ |
| Route | Intravenous | “Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.” NCT03602339 ↗ |