Drugs / Iopamidol
Iopamidol
also known as
Isovue · iopamidol-370 · Gastromiro (Iopamidol) · iopamidol injection · IOPAMIRO · Iopamiro-370 · ISOVUE-370
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | ISOVUE-250 | — | 1986-09-10 – 2025-10-10 | fda.gov ↗ |
| Approved | US (FDA) | ISOVUE-250 | — | 1985-12-31 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT01252810 | Nov 2010 → Dec 2012 | chronic renal failure syndrome, congestive heart failure, diabetes mellitus | GE Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00558792 | Nov 2007 → May 2010 | coronary stenosis | Bracco Diagnostics, Inc | Completed | Mixed |
| Phase 49 trials · 1 missed | ||||||
| Phase 4 | NCT03779906 | Mar 2019 → Nov 2021 | hypothyroidism | Bracco Diagnostics, Inc | Terminated | No outcome recorded |
| Phase 4 | NCT03557385 | Jan 2019 → May 2022 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT03384979 | Dec 2017 → Feb 2019 | — | IRCCS Policlinico S. Donato | Completed | No outcome recorded |
| Phase 4 | NCT01137786 | Dec 2010 → Apr 2012 | coronary stenosis | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT01075217 | Apr 2010 → Dec 2011 | peripheral arterial occlusive disease 1 | Bracco Diagnostics, Inc | Completed | Missed primary |
| Phase 4 | NCT00351754 | Jul → Nov 2006 | pulmonary embolism | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00289614 | Jan 2006 → Apr 2007 | kidney disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00289029 | Jul 2005 → Jun 2006 | — | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00292487 | Nov 2004 → Feb 2006 | acute tubulointerstitial nephritis | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05489055 | Feb 2022 → Jan 2023 | — | Chongqing Emergency Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 1 | NCT04504331 Background | Oct 2020 → Oct 2021 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | Jennifer Lee Caswell-Jin | Terminated | No outcome recorded |
| Phase 1/2 | NCT01672996 Comparator | Jul → Aug 2012 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT06411795 Background | Nov 2023 → Jan 2027 expected | pancreatic neoplasm, tumor of duodenum | Masonic Cancer Center, University of Minnesota | Recruiting | No outcome recorded |
| Phase 4 | NCT02467075 Comparator | Jul → Sep 2015 | acute kidney injury | University of Michigan | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02291718 Comparator | Jan 2014 → Sep 2015 | thoracic aortic aneurysm | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02040285 Comparator | Feb → Jul 2012 | — | Azienda Policlinico Umberto I | Completed | No outcome recorded |
| Phase 4 | NCT01475097 Comparator | Oct 2011 → Feb 2013 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT01376089 Comparator | May → Oct 2011 | — | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT01136876 Comparator | Nov 2010 → Nov 2012 | coronary stenosis | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT01136915 Comparator | Nov 2010 → Nov 2012 | coronary stenosis | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00782639 Comparator | Mar → Sep 2009 | chronic kidney disease, diabetes mellitus | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01402219 Comparator | Nov 2008 → Feb 2013 | chronic kidney disease | Guangdong Provincial People's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00740207 Comparator | Sep 2008 → Jul 2009 | peripheral arterial occlusive disease 1 | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00209417 Comparator | Jun 2005 → May 2011 | diabetes mellitus, impaired renal function disease | GE Healthcare | Terminated | No outcome recorded |
| — | NCT02433665 Comparator | Aug 2015 → Oct 2016 | — | Duke University | Terminated | No outcome recorded Stop: Enrollment |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Iopamidol | “ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution” NCT00740207 ↗23“Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.” NCT01252810 ↗ “70 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second” NCT00558792 ↗ “IOPAMIDOL 370” NCT01137786 ↗ |
| Known as | Gastromiro (Iopamidol) | “Gastromiro (Iopamidol)” NCT02040285 ↗ |
| Known as | iopamidol injection | “(iopamidol injection; Consun Pharmaceutical, China)” NCT05489055 ↗ |
| Known as | iopamidol-370 | “The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320...” NCT00782639 ↗1“A contrast bolus of iopamidol-370 (370 mg I/ml)” NCT05489055 ↗ |
| Known as | IOPAMIRO | “IOPAMIRO® (Iopamidol) is an x-ray contrast medium of the new generation of non-ionic compounds, which are watersoluble because the molecular structure incorporates hydrophilic groups.” NCT03384979 ↗ |
| Known as | Iopamiro-370 | “Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution” NCT00782639 ↗ |
| Known as | Isovue | “Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.” NCT01252810 ↗ |
| Known as | ISOVUE-370 | “aFFR measurement with drug: Iopamidol (ISOVUE®-370).” NCT03557385 ↗ |
| Modality | Diagnostic / imaging agent | “X-ray contrast media” NCT00209417 ↗ |
| Route | Intravenous | “intravenous use of X-ray contrast media” NCT00209417 ↗ |