OMNIPAQUE 140 (iohexol)
Omnipaque is a radiographic contrast agent used to help clinicians visualize internal body structures during various imaging procedures. It helps both adult and pediatric patients by improving the clarity of X-rays and CT scans across multiple areas of the body, including the spine, blood vessels, and digestive tract. This agent is used for diagnostic tests ranging from cardiac imaging to examinations of the joints and body cavities.
How OMNIPAQUE 140 Works
This agent works by using iodine atoms to attenuate X-rays in direct proportion to the concentration of the drug in the body. As the concentration changes over time, it provides time-dependent contrast that helps clinicians better visualize specific body structures.
Details
- Status
- Prescription
- First Approved
- 1985-12-26
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OMNIPAQUE 140 Approval History
What OMNIPAQUE 140 Treats
10 indicationsOMNIPAQUE 140 is approved for 10 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelography and CT myelography
- CT cisternography
- Cardiac ventriculography
- Aortography
- Coronary arteriography
- Cerebral arteriography
- Peripheral arteriography
- Intra-arterial digital subtraction angiography
OMNIPAQUE 140 Boxed Warning
RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyp...
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions (5.1) ]. WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 and 350 mg IODINE/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures. Intrathecal administration of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. ( 2.2 , 2.8 , 5.1 )
OMNIPAQUE 140 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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Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06709521 | 23-0013 5UM1AI104681-12 | Ph 4 | recruiting | Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI) |
| NCT03997370 | NRG-GY022 NCI-2019-04008, NRG-GY022 | Ph 1 | active not recruiting | Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol |
| NCT04649229 | 2000028712 | Ph 4 | completed | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3 |
| NCT02050269 IoxRea | PHAO13-SE / IoxRea 2013-003936-65, 2013-R49 | Ph 3 | completed | Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study |
| NCT04113109 | #191228 | Ph 4 | completed | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 |
| NCT05105009 | 19-1131 | Ph 1 | completed | Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function |
| NCT02772276 results posted | ORFM-2 | Ph 2 | completed | Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types |
| NCT05615467 | 18629 J2P-MC-LXBE | Ph 1 | completed | A Study of Effect of LY3556050 on Metformin in Healthy Participants |
| NCT05580250 | 18353 J2D-JE-CVAD | Ph 1 | withdrawn | A Study of LY3526318 in Healthy Male Japanese Participants |
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
| NCT04627831 | CE-Iohexol - Study 201 Ligand 201, CAP201 | Ph 2 | withdrawn | Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography |
| NCT04742816 | CCTG 605s | Ph 4 | completed | Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients |
| NCT01839526 | AGAL19110 2012-001966-14, MSC 12711 | Ph 1 | terminated | A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease |
| NCT04156750 | 17612 J2P-MC-LXBA | Ph 1 | completed | A Study of LY3556050 in Healthy Participants |
| NCT03826602 | SGNTUC-020 | Ph 1 | completed | A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin |
| NCT03415997 | NSHA REB 1023119 | Ph 4 | completed | Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight |
| NCT02884089 results posted | 16536 I3Y-MC-JPCK | Ph 1 | completed | A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants |
| NCT03545087 | 16007 I8D-MC-AZEN | Ph 1 | withdrawn | A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants |
| NCT02246998 results posted | GS-US-236-0140 2014-002095-93 | Ph 4 | completed | Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults |
| NCT02522338 HIVOL | 1008078 2010-022272-31 | Ph 4 | completed | Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance |
| NCT07643467 FLARE | 105008 | Ph 4 | not yet recruiting | Fluorescent Probe for Assessment of Renal Elimination |
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.
OMNIPAQUE 140 FDA Label Details
Indications & Usage
FDA Label (PDF)OMNIPAQUE 140 is indicated for the treatment of Myelography and CT myelography; CT cisternography; Cardiac ventriculography; Aortography; Coronary arteriography; Cerebral arteriography; Peripheral arteriography; Intra-arterial digital subtraction angiography; Pulmonary angiography; Excretory urography.
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNI...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.