iodixanol
Trade name: visipaque
Approved
Mar 22, 1996
Iodixanol (brand name VISIPAQUE) is an iodine-containing nonionic dimeric hydrophilic contrast agent for intravascular (intravenous and intra-arterial) use during coronary angiography. Pharmacodynamics studies indicated that iodixanol had fewer cardiovascular effects, caused less renal damage and were associated with similar or smaller changes to the blood-brain barrier and neurological function when compared with nonionic contrast media. It is known, that the organic iodine compounds attenuate x-rays as they pass through the body, thereby allowing the body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. Thus, after intravascular administration, iodixanol makes opaque those internal structures in its path of flow, allowing their visualization until significant hemodilution and elimination occur. — NCATS
Clinical trial activity
42 trials · 39 clinical orgs · 2 marketing orgs
Earliest trial started Jan 1, 2004 (NCT00247325)
Timeline
1990s
- Mar 22, 1996
General Electric — Earliest FDA Approval
- Mar 22, 1996
General Electric — NDA Secondary Org
- Mar 22, 1996
General Electric — NDA Organization
2000s
- Jan 1, 2006
General Electric — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2009
General Electric — Earliest Phase 1 Sponsor(trial)
2020s
- May 19, 2022
Hengrui Therapeutics, Inc. — Marketing Organization
Indications
Approved for
Studied for
- Angioplasty, Balloon, Coronary · Phase 4
- Arterial Occlusive Diseases · Phase 4
- Atherosclerosis · Phase 3
- Back Pain · Phase 4
- Carotid Stenosis · Phase 3
- Contrast Media · Phase 4
- Coronary Angiography · Phase 4
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 3
- Coronary Stenosis · Phase 4
- Diabetes Mellitus · Phase 4
- Diagnostic Imaging · Phase 4
- Head and Neck Neoplasms · Phase 1
- Healthy Volunteers · Phase 1/Phase 2
- Hypothyroidism · Phase 4
- Ischemic Stroke · Phase 3
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Lung Neoplasms · Phase 4
- Myocardial Infarction · Phase 4
- Pharmacological and Toxicological Phenomena · Phase 4
- Pulmonary Embolism · Phase 4
- Renal Artery Obstruction · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Rhinitis, Allergic, Seasonal · Phase 1/Phase 2
Mechanism of action
- Unspecified targetOTHER
Diagnostic agent
- contrast mediumRadiopaque
contrast medium radiopaque
Approval history
- approvedMar 22, 1996
Chemistry & pharmacology
SMILES
CC(=O)N(CC(O)CN(C(C)=O)C1=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C1I)C2=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C2I- Mol. weight
- 1550.1819 g/mol
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaIodixanol ↗
- NCATSHW8W27HTXX ↗
- ChEMBLCHEMBL1200507 ↗
Also known as
- 1,3-benzenedicarboxamide, 5,5'-((2-hydroxy-1,3-propanediyl)bis(acetylimino))bis(n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo)-, (16alpha)-
- 2-541o-3a
- 2-541o-3a
- 5,5'-((2-hydroxytrimethylene)bis(acetylimino))bis(n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide)
- 5,5'-((2-hydroxytrimethylene)bis(acetylimino))bis(n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide)
- contrast media 2-5410-3
- indixanol
- indixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol
- iodixanol-320
- iodixanolum
- iodixanolum
- nasapaque
- pegylated liposomal iodixanol
- visiopaque
- visipaque
- visipaque
- visipaque
- visipaque
- visipaque
- visipaque
- visipaque
- visipaque 270
- visipaque 270
- visipaque 320
- visipaque 320
- visipaque 320
- visipaque unique softpac
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05490381 | Phase 1 | Jan 5, 2023 | Guerbet, University of Washington |
| NCT05065073 | Phase 4 | Sep 30, 2021 | Minneapolis Heart Institute |
| NCT03631771 | Phase 4 | Feb 28, 2019 | Bayer, Duke University, General Electric |
| NCT03119662 | Phase 4 | Jun 1, 2017 | General Electric, INC Research |
| NCT02718521 | N/A | Mar 1, 2016 | People's Liberation Army of China |
| NCT01935141 | N/A | Jan 1, 2016 | Department of Veteran Affairs |
| NCT02377895 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2015 | 3E Therapeutics Corporation, ORA, Inc. |
| NCT02063594 | Phase 1 | Mar 1, 2014 | IQVIA, Marval Pharma Ltd. |
| NCT02405377 | N/A | Feb 1, 2014 | People's Liberation Army of China |
| NCT01908309 | Early Phase 1 (Phase 1) | Apr 1, 2013 | Azienda Sanitaria Locale 9, Grosseto |
| NCT01843426 | N/A | Feb 1, 2013 | General Electric, Medical University of South Carolina, University of South Carolina |
| NCT01848899 | Phase 4 | Feb 1, 2013 | Guerbet, New York University |
| NCT03333330 | Phase 3 | Apr 30, 2012 | University of Milan, Vita-Salute University of Milano. Italy |
| NCT01580046 | Phase 4 | Apr 1, 2012 | Peking University |
| NCT01475097 | Phase 4 | Oct 1, 2011 | General Electric, Optum |
| NCT01376089 | Phase 4 | May 1, 2011 | General Electric, Optum |
| NCT01137786 | Phase 4 | Dec 1, 2010 | Bracco |
| NCT01136876 | Phase 4 | Nov 1, 2010 | Bracco |
| NCT01136915 | Phase 4 | Nov 1, 2010 | Bracco |
| NCT01075217 | Phase 4 | Apr 1, 2010 | Bracco |
Organizations
Research & Development (39)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| General Electric | For profit | 13 | 11 | 4 | 2005 |
| Bracco | For profit | 6 | 6 | 1 | 2008 |
| People's Liberation Army of China | Government | 4 | 3 | 2 | 2008 |
| Guerbet | For profit | 3 | 1 | 2 | 2006 |
| Optum | For profit | 3 | 0 | 2 | 2009 |
| Department of Veteran Affairs | Government | 2 | 2 | 2 | 2008 |
| Duke University | Academic/Hospital | 2 | 1 | 2 | 2008 |
| IQVIA | For profit | 2 | 0 | 2 | 2005 |
| Seoul National University | Academic/Hospital | 2 | 2 | 1 | 2004 |
| University of Milan | Academic/Hospital | 2 | 1 | 2 | 2008 |
| 3E Therapeutics Corporation | For profit | 1 | 1 | 1 | 2015 |
| ABX-CRO | For profit | 1 | 0 | 1 | 2005 |
| Aptiv Solutions | For profit | 1 | 0 | 1 | 2005 |
| Azienda Sanitaria Locale 9, Grosseto | Government | 1 | 1 | 1 | 2013 |
| Bayer | For profit | 1 | 0 | 1 | 2019 |
| Covance | For profit | 1 | 0 | 1 | 2005 |
| Examination Management Services Inc. | For profit | 1 | 0 | 1 | 2005 |
| INC Research | For profit | 1 | 0 | 1 | 2017 |
| Mallinckrodt | For profit | 1 | 1 | 1 | 2009 |
| Marval Pharma Ltd. | For profit | 1 | 1 | 1 | 2014 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| General Electric | For profit | NDA2 | Mar 22, 1996 |
| General Electric | For profit | NDA | Mar 22, 1996 |
| Hengrui Therapeutics, Inc. | For profit | MKTG | May 19, 2022 |