GADOBUTROL
Gadobutrol is a gadolinium-based contrast agent used with magnetic resonance imaging (MRI) to visualize specific tissues and vascular structures. It is indicated for use in adult and pediatric patients, including term neonates, for CNS imaging to detect blood-brain barrier disruption or abnormal vascularity, and for magnetic resonance angiography (MRA) to evaluate supra-aortic or renal artery disease. In adult patients, it is also indicated to assess the presence and extent of malignant breast disease and to evaluate myocardial perfusion (stress/rest) and late gadolinium enhancement in those with known or suspected coronary artery disease.
How GADOBUTROL Works
Gadobutrol works by shortening the T1 and T2 relaxation times of protons when placed within a magnetic field. In T1-weighted sequences, this shortening increases radiofrequency signal intensity, enhancing the visualization of both normal and pathological tissues. In T2*-weighted sequences, the large magnetic moment of gadolinium induces local magnetic field inhomogeneities, which can lead to a signal decrease, particularly at high concentrations during bolus injection. The extent of signal change depends on the gadobutrol concentration, the MRI field strength, and the specific imaging sequence used.
Details
- Status
- Prescription
- First Approved
- 2022-11-17
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GADOBUTROL Approval History
What GADOBUTROL Treats
5 indicationsGADOBUTROL is approved for 5 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Disrupted Blood Brain Barrier
- Abnormal Vascularity of the Central Nervous System
- Malignant Breast Disease
- Supra-Aortic Artery Disease
- Renal Artery Disease
GADOBUTROL Boxed Warning
RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol injection is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination...
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol injection is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of drugs. Avoid use of gadobutrol injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or o Acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended gadobutrol injection dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )] . WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning • Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol injection is not approved for intrathecal use ( 5.1 ) • GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of drugs. Avoid use of gadobutrol injection in these patients unless t
GADOBUTROL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
GADOBUTROL FDA Label Details
Indications & Usage
GADOBUTROL is indicated for the treatment of Disrupted Blood Brain Barrier; Abnormal Vascularity of the Central Nervous System; Malignant Breast Disease; Supra-Aortic Artery Disease; Renal Artery Disease.
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol injection is...
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GADAVIST
Full clinical data, patents, trials, and competitive landscape for gadobutrol.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.