PIXXOSCAN (gadobutrol) · GE HLTHCARE
PIXXOSCAN is FDA-approved to treat 6 conditions (same as GADAVIST).
Details
- Status
- Prescription
- First Approved
- 2026-06-29
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PIXXOSCAN Approval History
What PIXXOSCAN Treats
6 indicationsPIXXOSCAN is approved for 6 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Disrupted Blood Brain Barrier
- Abnormal Vascularity
- Malignant Breast Disease
- Supra-Aortic Artery Disease
- Renal Artery Disease
- Coronary Artery Disease
Same approved indications as GADAVIST (same active ingredient).
GE HLTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07472491 LUMINA | GE-227-203 2025-523862-25-00 | Ph 2, Ph 3 | recruiting | A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients |
| NCT04893434 | 21-038 | Ph 1 | active not recruiting | Novel Imaging Technique to Assess Gynecologic Cancer |
| 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) |
| NCT04910425 | NU 19U05 NCI-2021-05593, STU00212326 | Ph 2 | withdrawn | PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer |
| NCT06224543 | 22403 | Ph 1 | completed | MR Image Synthesis With Low Gadobutrol Dose and AI |
| 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 |
| NCT06731829 | HRS-9231-201 | Ph 2 | not yet recruiting | A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions |
| NCT03404648 results posted | 16-007897 | Ph 3 | completed | Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI |
| NCT02274246 RESTORE-HV | RESTORE-HV | Ph 1 | completed | Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV) |
| NCT01613417 TRUTH results posted | PH-107 | Ph 4 | completed | Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
PIXXOSCAN FDA Label Details
Indications & Usage
PIXXOSCAN is FDA-approved to treat 6 conditions — same approved indications as GADAVIST.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.