Overview
Iodixanol is a nonionic hydrophilic compound commonly used as a contrast agent during coronary angiography, particularly in individuals with renal dysfunction, as it is believed to be less toxic to the kidneys than most other intravascular contrast agents.
Indication
Iodixanol is a contrast agent during coronary angiography.
Associated Conditions
No associated conditions information available.
Research Report
An Expert Report on Iodixanol (Visipaque®): Pharmacology, Clinical Use, and Comparative Safety
Executive Summary
Iodixanol is a third-generation, non-ionic, dimeric, hexa-iodinated radiographic contrast agent representing a significant development in medical imaging.[1] Marketed principally under the brand name Visipaque®, its defining physicochemical characteristic is its iso-osmolality. At all clinically relevant concentrations, it is isotonic to human blood, with an osmolality of approximately 290 mOsm/kg H₂O, a feature unique among intravascular contrast media.[3] This property was engineered to improve the safety and tolerability profile of iodinated contrast agents, particularly in high-risk patient populations.[5]
Clinically, Iodixanol is utilized for a broad spectrum of intra-arterial and intravenous radiographic procedures. Its applications include angiography, venography, excretory urography, and contrast-enhanced computed tomography (CECT) of the head and body.[6] Notably, it is the only contrast agent with a specific U.S. Food and Drug Administration (FDA) approved indication for Coronary Computed Tomography Angiography (CCTA), positioning it as a key tool in the non-invasive diagnostic evaluation of coronary artery disease.[8]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2013/05/08 | Phase 4 | Completed | |||
2012/04/18 | Phase 4 | UNKNOWN | Yong Huo | ||
2011/11/21 | Phase 4 | Completed | |||
2011/07/26 | Phase 4 | Terminated | |||
2011/06/20 | Phase 4 | Completed | |||
2011/03/30 | N/A | Terminated | |||
2010/08/25 | Not Applicable | Terminated | |||
2010/06/17 | Not Applicable | Completed | |||
2010/06/04 | Phase 4 | Terminated | |||
2010/06/04 | Phase 4 | Completed |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VISIPAQUE iodixanol 27.5g/50mL (550mg/mL) injection vial | 49603 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection vial | 49594 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 97.8g/150mL (652mg/mL) injection bottle | 49598 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 65.2g/100mL (652mg/mL) injection bag | 49600 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 6.5g/10mL (652mg/mL) injection ampoule | 75927 | Medicine | A | 11/30/2000 | |
VISIPAQUE iodixanol 13.0g/20mL (652mg/mL) injection ampoule | 75928 | Medicine | A | 11/30/2000 | |
VISIPAQUE iodixanol 110g/200mL (550g/mL) injection bottle | 49606 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 26.1g/40mL (652mg/mL) injection ampoule | 75930 | Medicine | A | 11/30/2000 | |
VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection ampoule | 75926 | Medicine | A | 11/30/2000 | |
VISIPAQUE iodixanol 5.5g/10mL (550mg/mL) injection ampoule | 75923 | Medicine | A | 11/30/2000 |
Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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