ELUCIREM (gadopiclenol)
Elucirem (gadopiclenol) is a gadolinium-based contrast agent (GBCA) indicated for use with magnetic resonance imaging (MRI) in adults and pediatric patients aged 2 years and older. It is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and other body regions, including the head and neck, thorax, abdomen, pelvis, and musculoskeletal system.
How ELUCIREM Works
Gadopiclenol is a paramagnetic, macrocyclic, non-ionic gadolinium complex. When placed within a magnetic field, it develops a magnetic moment that alters the relaxation rates of water protons in its vicinity. This leads to an increase in signal intensity (brightness) in the affected tissues, enhancing the visualization of lesions and vascular structures during MRI.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-09-21
- Patent Cliff
- 2040
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
ELUCIREM Approval History
What ELUCIREM Treats
1 indicationsELUCIREM is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lesions with Abnormal Vascularity
ELUCIREM 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. ELUCIREM 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 drug...
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. ELUCIREM 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 ELUCIREM 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. For patients at highest risk for NSF, do not exceed the recommended ELUCIREM 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. ELUCIREM 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 ELUCIREM in these patients unless the diagnostic information is essential and not available with non-contrast
ELUCIREM 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 ELUCIREM
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06846853 MRI | 25-175-1 | Ph 4 | recruiting | Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging) |
| NCT06057168 GDX-44-016 results posted | GDX-44-016 | Ph 3 | completed | Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas |
| NCT07348640 | GDX-102 - GDX-44-017 2024-518835-13-00 | Ph 3 | not yet recruiting | 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 |
| NCT07040865 IRAF-WORKUP | BASEC 2025-00253 BASEC 2025-00253 | Ph 4 | recruiting | Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings |
| NCT05590884 results posted | GDX-44-015 | Ph 2 | completed | Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age |
| NCT03986138 PROMISE results posted | GDX-44-011 | Ph 3 | completed | Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) |
| NCT06226129 | AAAV5623 | Ph 4 | recruiting | Gadopiclenol in Contrast Enhanced MRI of the Prostate |
| NCT03996447 PICTURE results posted | GDX-44-010 | Ph 3 | completed | Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) |
| NCT06010173 | GDX-44-014 - GDX-101 | Ph 3 | completed | Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children |
| NCT04906005 | GDX-44-013 jRCT2071210029 | Ph 1 | completed | Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers |
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.
ELUCIREM FDA Label Details
Indications & Usage
FDA Label (PDF)ELUCIREM is indicated for the treatment of Lesions with 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. ELUCIREM is not approve...
ELUCIREM Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ELUCIREM
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 189 active patents
Trial Analysis
- • 11 total trials
- • Stage: Expansion
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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