DOTAREM (gadoterate meglumine)
Dotarem is a gadolinium-based contrast agent indicated for intravenous use during MRI scans of the brain (intracranial), spine, and associated tissues in adults and pediatric patients, including term neonates. It is used to detect and visualize areas where the blood-brain barrier is disrupted or where there is abnormal vascularity, assisting in the identification of various central nervous system pathologies.
How DOTAREM Works
Dotarem is a paramagnetic molecule that develops a magnetic moment when placed within an MRI's magnetic field. This interaction enhances the relaxation rates of nearby water protons, shortening both T1 and T2 relaxation times. This leads to an increase in signal intensity (brightness) of the target tissues. At recommended doses, this effect is observed with the greatest sensitivity in T1-weighted sequences, helping to highlight differences between normal and pathological tissues.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-03-20
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
DOTAREM Approval History
What DOTAREM Treats
2 indicationsDOTAREM is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Disruption of the Blood Brain Barrier
- Abnormal Vascularity
DOTAREM 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. DOTAREM 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 the drugs...
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. DOTAREM 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 the drugs. Avoid use of DOTAREM 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: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), or 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 (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.1 ). For patients at highest risk for NSF, do not exceed the recommended DOTAREM 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. DOTAREM is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of DOTAREM in these patients unless the diagnostic information is essential and not available with non-contr
DOTAREM 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.
Drugs Similar to DOTAREM
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06600880 FUS-AD | AAAV4854 | Ph 1 | not yet recruiting | Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau |
| NCT07572383 | 2024P001746Aim3 R01HL171240 | Ph 2 | recruiting | Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis |
| NCT06532071 | 2024P001746 | Ph 2 | recruiting | Advanced Imaging for Pulmonary Fibrosis |
| NCT05417776 | 2022P001087 | Ph 2 | recruiting | Collagen-targeted PET Imaging for Early Interstitial Lung Disease |
| NCT03730051 | H00020209 | Ph 4 | completed | Dotarem vs Gadobutrol Contrast for Breast MRI |
| NCT06057168 GDX-44-016 results posted | GDX-44-016 | Ph 3 | completed | Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas |
| 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) |
| 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 |
| NCT01806740 DCE-MRI results posted | DGD-44-057 | Ph 4 | terminated | DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC |
| NCT01254552 ACCREDIT results posted | ISO-44-011 | Ph 4 | completed | Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis |
| NCT02411201 results posted | DGD-44-063 2013-003215-21 | Ph 4 | completed | DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years |
| NCT02070380 BENEFIT results posted | MH-148 | Ph 4 | completed | Crossover Comparison of MultiHance and Dotarem |
| NCT01012674 results posted | DGD-44-049 | Ph 3 | completed | Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) |
| NCT01010932 results posted | DGD-44-048 | Ph 3 | completed | Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) |
| NCT00980681 results posted | DGD-44-047 | Ph 3 | terminated | Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF) |
| NCT00764387 | 91780 2007-005693-31, 312021 | Ph 4 | completed | Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions. |
| NCT01026389 DALIA results posted | DGD 44-045 | Ph 4 | completed | Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease |
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.
DOTAREM FDA Label Details
Indications & Usage
FDA Label (PDF)DOTAREM is indicated for the treatment of Disruption of the Blood Brain Barrier; Abnormal Vascularity.
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. DOTAREM is not approved...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment