NDAINTRAVENOUSSOLUTION
Approved
Mar 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GADAVIST (gadobutrol) by Bayer is magnetic resonance contrast activity [moa]. Approved for gadolinium-based contrast agent [epc]. First approved in 2011.
Drug data last refreshed 6h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GADAVIST (gadobutrol) is a gadolinium-based contrast agent administered intravenously to enhance MRI imaging by improving visualization of tissues and lesions. It works through magnetic resonance contrast activity, enabling clearer diagnostic imaging across multiple anatomical regions. This small-molecule contrast agent is indicated for diagnostic MRI procedures requiring contrast enhancement.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team consolidation and shift toward defending market share.
Mechanism of Action
Magnetic Resonance Contrast Activity
Pharmacologic Class:
Gadolinium-based Contrast Agent
Indications (1)
Clinical Trials (20)
MR Image Synthesis With Low Gadobutrol Dose and AI
Started Jun 2023
60 enrolled
Enhancing Brain Lesions
A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting
Started Nov 2022
1,602 enrolled
Contrast Enhancement in Magnetic Resonance Imaging
Dotarem vs Gadobutrol Contrast for Breast MRI
Started Mar 2021
300 enrolled
Breast Diseases
Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Started Jun 2014
279 enrolled
Primary Brain Tumor
Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Started Aug 2013
478 enrolled
Coronary Artery Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.