ULTRAVIST (PHARMACY BULK) (iopromide)
Ultravist is an iodinated contrast agent used to help healthcare providers visualize internal structures during diagnostic imaging. It helps patients by making blood vessels and organs appear more clearly on X-rays, CT scans, and mammograms. This agent is used for both adults and pediatric patients aged two and older to evaluate various regions including the heart, brain, and abdominal organs.
How ULTRAVIST (PHARMACY BULK) Works
This agent works by opacifying the blood vessels where it is present, which allows for radiographic visualization through the attenuation of photons. While it normally diffuses into the extravascular space in the body, it stays within the vessels of a healthy brain unless there is a disruption in the blood-brain barrier.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-09-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ULTRAVIST (PHARMACY BULK) Approval History
What ULTRAVIST (PHARMACY BULK) Treats
10 indicationsULTRAVIST (PHARMACY BULK) is approved for 10 conditions since its original approval in 2002. 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 (PHARMACY BULK) 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 (PHARMACY BULK) 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.
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Other CDER-designated drugs from the same sponsor (2016–2025).
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 (PHARMACY BULK) FDA Label Details
Indications & Usage
FDA Label (PDF)ULTRAVIST (PHARMACY BULK) 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 for breast lesions.
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.
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