Data updated: May 26, 2026
GADOTERATE MEGLUMINE
Other
Approved 2022-04-11
2
Indications
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-04-11
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GADOTERATE MEGLUMINE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2022 to 2024
Jun 2024 ORIGINAL
Update
Apr 2022 ORIGINAL
Update
What GADOTERATE MEGLUMINE Treats
2 FDA approvalsOriginally approved for its first indication in 2022 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Apr 2022)
- • Approved indication (Jun 2024)
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07572383 | 2024P001746Aim3 R01HL171240 | Ph 2 | recruiting | Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis |
| NCT06532071 | 2024P001746 | Ph 2 | recruiting | Advanced Imaging for Pulmonary Fibrosis |
| NCT03730051 | H00020209 | Ph 4 | completed | Dotarem vs Gadobutrol Contrast for Breast MRI |
| NCT04373564 ODYSSEY | DGD-44-065 20405, GMRA-105 | Ph 4 | recruiting | Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years |
| NCT05915728 Quanti OBR | 21197 2022-501885-24-00 | Ph 3 | completed | A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems) |
| NCT05915702 Quanti CNS | 21181 2022-501884-41-00 | Ph 3 | completed | A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems |
| NCT01806740 DCE-MRI results posted | DGD-44-057 | Ph 4 | terminated | DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC |
| NCT01254552 ACCREDIT results posted | ISO-44-011 | Ph 4 | completed | Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GADOTERATE MEGLUMINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.