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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/10/01 | Phase 4 | UNKNOWN | |||
2018/09/14 | N/A | Completed | |||
2018/08/15 | Phase 4 | Withdrawn | |||
2017/11/06 | Phase 3 | Completed | Enrico Ammirati | ||
2017/04/18 | Phase 4 | Terminated | |||
2016/03/24 | Not Applicable | UNKNOWN | Chinese PLA General Hospital | ||
2015/04/01 | Not Applicable | Completed | Chinese PLA General Hospital | ||
2014/06/24 | Phase 3 | Completed | |||
2013/09/04 | Not Applicable | Withdrawn | VA Greater Los Angeles Healthcare System | ||
2013/07/25 | Early Phase 1 | Completed | Azienda Sanitaria Locale 9, Grosseto |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
GE Healthcare Inc. | 0407-2223 | INTRAVASCULAR | 320 mg in 1 mL | 4/30/2023 | |
GE Healthcare Inc. | 0407-2222 | INTRAVASCULAR | 270 mg in 1 mL | 4/30/2023 | |
GE Healthcare Inc. | 0407-2223 | INTRAVASCULAR | 320 mg in 1 mL | 3/1/2024 | |
FRESENIUS KABI USA, LLC | 65219-381 | INTRAVASCULAR | 270 mg in 1 mL | 5/31/2022 | |
GE Healthcare Inc. | 0407-2223 | INTRAVASCULAR | 320 mg in 1 mL | 4/30/2023 | |
GE Healthcare Inc. | 0407-2222 | INTRAVASCULAR | 270 mg in 1 mL | 4/30/2023 | |
FRESENIUS KABI USA, LLC | 65219-383 | INTRAVASCULAR | 320 mg in 1 mL | 5/31/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
VISIPAQUE INJECTION 320 mgI/ml | SIN08883P | INJECTION | 652 mg/ml | 8/28/1996 | |
VISIPAQUE INJECTION 270 mgI/ml | SIN08882P | INJECTION | 550 mg/ml | 8/28/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
VISIPAQUE INJ 320MG I/ML | N/A | N/A | N/A | 9/5/1998 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VISIPAQUE iodixanol 110g/200mL (550mg/mL) injection bag | 49609 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 13.0g/20mL (652mg/mL) injection ampoule | 154370 | Medicine | A | 10/29/2008 | |
VISIPAQUE iodixanol 82.5g/150mL (550mg/mL) injection bag | 49608 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 27.5g/50mL (550mg/mL) injection ampoule | 75925 | Medicine | A | 11/30/2000 | |
VISIPAQUE iodixanol 11.0g/20mL (550mg/mL) injection vial | 154369 | Medicine | A | 10/29/2008 | |
VISIPAQUE iodixanol 130.4g/200mL (652mg/mL) injection bag | 49602 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 65.2g/100mL (652mg/mL) injection bottle | 49597 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 97.8g/150mL (652mg/mL) injection bag | 49601 | Medicine | A | 6/27/1995 | |
VISIPAQUE iodixanol 11.0g/20mL (550mg/mL) injection vial | 75924 | Medicine | A | 11/30/2000 | |
VISIPAQUE iodixanol 22.0g/40mL (550mg/mL) injection ampoule | 75929 | Medicine | A | 11/30/2000 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
IODIXANOL INJECTION 270 | fresenius kabi canada ltd | 02553953 | Solution - Intra-Arterial
,
Intravenous | 550 MG / ML | 5/29/2025 |
VISIPAQUE 270 | ge healthcare canada inc | 02145766 | Solution - Intra-Arterial
,
Intravenous | 550 MG / ML | 12/31/1995 |
IODIXANOL INJECTION 320 | fresenius kabi canada ltd | 02553961 | Solution - Intravenous
,
Intra-Arterial | 652 MG / ML | 5/29/2025 |
VISIPAQUE 320 | ge healthcare canada inc | 02145774 | Solution - Intra-Arterial
,
Intravenous | 652 MG / ML | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
VISIPAQUE 320 mg /ml SOLUCION INYECTABLE | Ge Healthcare Bio-Sciences, S.A.U. | 60637 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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