NDAINJECTION, ORALSOLUTION
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
OMNIPAQUE 350 (iohexol) by GE HealthCare is x-ray contrast activity [moa]. First approved in 1985.
Drug data last refreshed 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMNIPAQUE 350 (iohexol) is a non-ionic radiographic contrast agent administered via injection or oral route as a solution. It enhances X-ray visualization in diagnostic procedures including coronary angiography and imaging in diabetic kidney disease patients. The drug works by increasing radiodensity to improve image contrast in radiological examinations.
LOE Approaching
As a mature product approaching loss of exclusivity, brand teams face declining revenue and workforce optimization; manufacturing and supply chain roles remain critical to cost leadership.
Mechanism of Action
X-Ray Contrast Activity
Pharmacologic Class:
Radiographic Contrast Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Relative Bioavailability of CE-Iohexol (Captisol-enabled™ Iohexol) Injection and Omnipaque™ Injection
Started Apr 2019
24 enrolled
Contrast-induced NephropathyCoronary Angiography
A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
Started Aug 2016
40 enrolled
Healthy
Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles
Started Feb 2013
84 enrolled
Colorectal Neoplasms
A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects
Started Oct 2010
38 enrolled
Infections, Human Immunodeficiency Virus and Tuberculosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.