VISIPAQUE 270 (iodixanol) · GE HEALTHCARE
VISIPAQUE 270 is FDA-approved to treat 1 condition (same as VISIPAQUE 320).
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-03-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VISIPAQUE 270 Approval History
What VISIPAQUE 270 Treats
1 indicationsVISIPAQUE 270 is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as VISIPAQUE 320 (same active ingredient).
GE HEALTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
9 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| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |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 |
| NCT00740207 results posted | IOP-113 | Ph 4 | completed | Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA |
| 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 270 FDA Label Details
Indications & Usage
FDA Label (PDF)VISIPAQUE 270 is FDA-approved to treat 1 condition — same approved indications as VISIPAQUE 320.
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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