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Gadobutrol (Gadovist/Gadavist)
Gadobutrol (Gadovist/Gadavist) is a Gadolinium-based contrast agent (GBCA) Small molecule drug developed by Insel Gruppe AG, University Hospital Bern. It is currently FDA-approved for MRI contrast enhancement for brain imaging, MRI contrast enhancement for body imaging including liver, kidney, and other organs, MRI angiography.
Gadobutrol is a gadolinium-based contrast agent that enhances magnetic resonance imaging (MRI) by shortening the T1 relaxation time of water protons in tissues.
Gadobutrol is a gadolinium-based contrast agent that enhances magnetic resonance imaging (MRI) by shortening the T1 relaxation time of water protons in tissues. Used for MRI contrast enhancement for brain imaging, MRI contrast enhancement for body imaging including liver, kidney, and other organs, MRI angiography.
At a glance
| Generic name | Gadobutrol (Gadovist/Gadavist) |
|---|---|
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Drug class | Gadolinium-based contrast agent (GBCA) |
| Target | Water proton relaxation (T1 relaxation enhancement) |
| Modality | Small molecule |
| Therapeutic area | Diagnostic Imaging |
| Phase | FDA-approved |
Mechanism of action
Gadobutrol is a macrocyclic gadolinium chelate complex that distributes in the extracellular space and increases signal intensity on T1-weighted MRI images. The paramagnetic gadolinium ion accelerates the relaxation of nearby water protons, creating enhanced contrast that allows better visualization of tissue perfusion, vascularity, and pathological lesions during MRI examinations.
Approved indications
- MRI contrast enhancement for brain imaging
- MRI contrast enhancement for body imaging including liver, kidney, and other organs
- MRI angiography
Common side effects
- Headache
- Dizziness
- Nausea
- Injection site reactions
- Gadolinium retention (systemic)
Key clinical trials
- The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study (NA)
- Dotarem vs Gadobutrol Contrast for Breast MRI (PHASE4)
- A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients (PHASE2, PHASE3)
- Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
- Novel Imaging Technique to Assess Gynecologic Cancer (PHASE1)
- Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease (NA)
- A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions (PHASE3)
- Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gadobutrol (Gadovist/Gadavist) CI brief — competitive landscape report
- Gadobutrol (Gadovist/Gadavist) updates RSS · CI watch RSS
- Insel Gruppe AG, University Hospital Bern portfolio CI
Frequently asked questions about Gadobutrol (Gadovist/Gadavist)
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Related
- Drug class: All Gadolinium-based contrast agent (GBCA) drugs
- Target: All drugs targeting Water proton relaxation (T1 relaxation enhancement)
- Manufacturer: Insel Gruppe AG, University Hospital Bern — full pipeline
- Therapeutic area: All drugs in Diagnostic Imaging
- Indication: Drugs for MRI contrast enhancement for brain imaging
- Indication: Drugs for MRI contrast enhancement for body imaging including liver, kidney, and other organs
- Indication: Drugs for MRI angiography
- Compare: Gadobutrol (Gadovist/Gadavist) vs similar drugs
- Pricing: Gadobutrol (Gadovist/Gadavist) cost, discount & access