MedPath

Iodixanol

Generic Name
Iodixanol
Brand Names
Visipaque, Visipaque 270, Visipaque 320
Drug Type
Small Molecule
Chemical Formula
C35H44I6N6O15
CAS Number
92339-11-2
Unique Ingredient Identifier
HW8W27HTXX

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

Published: Aug 6, 2025

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]

Continue reading the full research report

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Withdrawn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Withdrawn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.

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

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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