VISIPAQUE 320 (iodixanol)
Visipaque 320 is an iso-osmolar, nonionic radiographic contrast agent used to visualize internal structures and blood vessels during diagnostic imaging. It is indicated for intra-arterial procedures (such as angiocardiography, peripheral arteriography, and cerebral arteriography) in adults and pediatric patients of all ages. For intravenous procedures, including CT imaging of the head and body, excretory urography, and coronary CT angiography (CCTA), it is indicated for adults and pediatric patients 12 years of age and older. By enhancing image clarity, it assists in the diagnostic evaluation of vascular and organ-related health concerns.
How VISIPAQUE 320 Works
Iodixanol provides radiographic opacification of blood vessels in the path of flow, allowing for the visualization of internal structures until significant hemodilution occurs. In general body imaging, the agent diffuses from the vascular space into the extravascular space. While it does not cross an intact blood-brain barrier, the agent will accumulate in the interstitial space of the brain in regions where the barrier has been disrupted by pathology.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-03-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VISIPAQUE 320 Approval History
What VISIPAQUE 320 Treats
1 indicationsVISIPAQUE 320 is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
VISIPAQUE 320 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 )
VISIPAQUE 320 Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00558142 results posted | NAC0606 NRES reference: 07/MRE00/64, EudraCT reference: 2006 | Ph 4 | completed | Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material |
| 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 |
| NCT02171247 results posted | Pro00004492 | Ph 3 | completed | Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA) |
| 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.
VISIPAQUE 320 FDA Label Details
Indications & Usage
FDA Label (PDF)VISIPAQUE 320 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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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