MULTIHANCE (gadobenate dimeglumine)
MultiHance is a contrast agent used to improve the clarity of diagnostic imaging in the brain, spine, and vascular system. It helps patients by highlighting lesions with abnormal blood flow or blood-brain barrier issues and is used for both adults and children, including newborn infants. In adult patients, it also assists in evaluating suspected blockages in the renal and pelvic arteries during specialized vascular scans.
How MULTIHANCE Works
This agent works by developing a magnetic moment when placed within an MRI's magnetic field, which enhances the relaxation rates of nearby water protons. This change in relaxation time increases the brightness of the tissue signal, making it easier to distinguish between normal and pathological structures. The effect is most sensitive during T1-weighted imaging sequences, where it significantly improves tissue visualization.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-11-23
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
MULTIHANCE Approval History
What MULTIHANCE Treats
3 indicationsMULTIHANCE is approved for 3 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Abnormal Blood-Brain Barrier
- Abnormal Vascularity
- Aorto-ilio-femoral Occlusive Vascular Disease
MULTIHANCE 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. MultiHance 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 dru...
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. MultiHance 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 MultiHance 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 systemic 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/1.73m 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 or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to 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. MultiHance 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 MultiHance in these patients unless the diagnostic information is essential and not available with n
MULTIHANCE 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 MULTIHANCE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04973007 | 19-1045.cc P30CA046934 | Ph 4 | terminated | Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases |
| 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 |
| NCT04910425 | NU 19U05 NCI-2021-05593, STU00212326 | Ph 2 | withdrawn | PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer |
| NCT03703492 results posted | UW18063 KL2TR000428, NCI-2018-02281 | Ph 2 | completed | Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS |
| NCT02633501 results posted | GDX-44-004 | Ph 2 | completed | P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) |
| NCT01710254 RECAD-AF results posted | REGA-12F08 | Ph 2 | completed | Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients |
| NCT01260636 VALUE | MH-137 | Ph 3 | completed | Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries |
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.
MULTIHANCE FDA Label Details
Indications & Usage
FDA Label (PDF)MULTIHANCE is indicated for the treatment of Abnormal Blood-Brain Barrier; Abnormal Vascularity; Aorto-ilio-femoral Occlusive Vascular 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. MultiHance is not appro...
Track MULTIHANCE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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