IODIXANOL
Iodixanol is a radiographic contrast agent used for diagnostic imaging in both adult and pediatric patients. It helps healthcare providers visualize internal structures during procedures like CT scans of the head and body, heart imaging, and examinations of the blood vessels. This agent is used for both intra-arterial and intravenous injections to assist in evaluating conditions such as coronary artery disease or urinary tract issues.
How IODIXANOL Works
This agent works by opacifying blood vessels along its path of flow, which allows for the clear visualization of internal structures during imaging. While it typically moves from the vascular system into the surrounding tissue in the body, it remains within the vessels of a healthy brain unless the blood-brain barrier is damaged. This accumulation in disrupted areas helps identify specific regions of concern during diagnostic procedures.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-05-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IODIXANOL Approval History
What IODIXANOL Treats
1 indicationsIODIXANOL is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
IODIXANOL Boxed Warning
NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] . WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, pa...
WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] . WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. ( 4 , 5.1 )
IODIXANOL 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 IODIXANOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
| NCT01848899 results posted | 12-02409 | Ph 4 | completed | Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography |
| NCT01475097 results posted | GE-012-098 | Ph 4 | completed | Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography |
| NCT01376089 results posted | GE-012-097 | Ph 4 | completed | Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis |
| NCT01402219 NEIHR | 2008A030201002 | Ph 4 | terminated | Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients |
| NCT01075217 results posted | IOP 119 | Ph 4 | completed | Isovue in Peripheral Digital Subtraction Angiography (DSA) |
| NCT00782639 RECARE results posted | IOP114 | Ph 4 | terminated | Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients |
| NCT00827788 CONTRAST-AMI | Arezzo001 EUDRACT 2008-008491-13 | Ph 4 | completed | Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) |
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.
IODIXANOL FDA Label Details
Indications & Usage
IODIXANOL is indicated for the treatment of Coronary Artery Disease.
WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( ...
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Full clinical data, patents, trials, and competitive landscape for iodixanol.
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