NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
DOTAREM (gadoterate meglumine) by Guerbet is field. First approved in 2013.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOTAREM (gadoterate meglumine) is an intravenous gadolinium-based contrast agent used to enhance MRI imaging by shortening T1 and T2 relaxation times in target tissues. It improves visualization of normal and pathological tissue by increasing signal intensity in magnetic resonance imaging. The drug is administered as an IV solution to patients requiring enhanced diagnostic imaging.
Peak
Peak lifecycle stage indicates established market presence with mature sales infrastructure; commercial teams focus on market defense and optimization rather than launch acceleration.
Mechanism of Action
field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
Started Feb 2026
315 enrolled
Steno-occlusive Disease
Dotarem vs Gadobutrol Contrast for Breast MRI
Started Mar 2021
300 enrolled
Breast Diseases
Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
Started Jul 2020
50 enrolled
Breast NeoplasmsBreast DiseasesBreast Fibroadenoma+1 more
Dotarem Evaluation for Myocardial Perfusion CMR
Started Jul 2019
90 enrolled
Myocardial Perfusion ImagingMagnetic Resonance Imaging
Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Started Nov 2018
157 enrolled
Magnetic Resonance Imaging
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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.