ULTRAVIST 370 (iopromide)
Ultravist (iopromide) is an iodinated contrast agent indicated for a wide range of radiographic procedures in adults and pediatric patients aged 2 years and older. Its intra-arterial applications include cerebral, peripheral, and coronary arteriography, as well as visceral angiography and aortography. Intravenous indications include excretory urography, contrast-enhanced CT of the head and body for the evaluation of neoplastic and non-neoplastic lesions, and contrast mammography in adults as an adjunct to standard imaging. Specific concentrations, such as Ultravist 370, are selected based on the requirements of the specific imaging procedure.
How ULTRAVIST 370 Works
Iopromide facilitates radiographic visualization by opacifying the blood vessels and attenuating photons. In most systemic tissues, the agent diffuses from the vasculature into the extravascular space. In the central nervous system, the drug remains confined to the intravascular space by an intact blood-brain barrier; it only accumulates in the extravascular space in areas where the barrier has been disrupted, allowing for the identification of pathology.
Details
- Status
- Prescription
- First Approved
- 1995-05-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ULTRAVIST 370 Approval History
What ULTRAVIST 370 Treats
10 indicationsULTRAVIST 370 is approved for 10 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cerebral arteriography
- Peripheral arteriography
- Coronary arteriography
- Left ventriculography
- Visceral angiography
- Aortography
- Radiographic evaluation of cardiac chambers and related arteries
- Excretory urography
ULTRAVIST 370 Boxed Warning
NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)...
WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)
ULTRAVIST 370 Competitive Set
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Clinical Trial Registry
3 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 |
| NCT01255722 X-ACT results posted | ISO-44-012 | Ph 4 | completed | Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography |
| 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.
ULTRAVIST 370 FDA Label Details
Indications & Usage
FDA Label (PDF)ULTRAVIST 370 is indicated for the treatment of Cerebral arteriography; Peripheral arteriography; Coronary arteriography; Left ventriculography; Visceral angiography; Aortography; Radiographic evaluation of cardiac chambers and related arteries; Excretory urography; Contrast computed tomography (CT) of the head and body; Contrast mammography.
WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seiz...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.