Drugs / Iopromide
Iopromide
also known as
Ultravist · Iopromida · Proscope · Ultravist (pharmacy bulk) · Ultravist 150 · Ultravist 240 · Ultravist 300 · Ultravist 370 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ULTRAVIST (PHARMACY BULK) | — | 2010-06-23 – 2023-05-25 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | ULTRAVIST 150 | — | 1997-07-23 – 2009-12-30 | fda.gov ↗ |
| Approved | US (FDA) | ULTRAVIST 150 | — | 1995-05-10 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00244140 | Oct 2005 → Apr 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03631771 | Mar 2022 → Aug 2024 | hypothyroidism | GE Healthcare | Withdrawn | No outcome recorded |
| Phase 4 | NCT00926562 | Feb 2009 → Dec 2010 | chronic renal failure syndrome | Chinese PLA General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00335101 | Jun 2006 → ? | coronary artery disorder, diabetes mellitus, impaired renal function disease | GE Healthcare | Withdrawn | No outcome recorded Stop: Business |
| Comparator or background therapy4 trials | ||||||
| Phase 4 | NCT01580046 Comparator | Apr 2012 → Dec 2013 | chronic renal failure syndrome | Yong Huo | Unknown | No outcome recorded |
| Phase 4 | NCT01255722 Comparator | Nov 2010 → Sep 2012 | coronary artery disorder | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT00823628 Comparator | Feb 2009 → May 2010 | chronic kidney disease, coronary artery disorder | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00827788 Comparator | Dec 2008 → Apr 2010 | acute myocardial infarction, acute tubulointerstitial nephritis | Ospedale San Donato | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-01-23 | Bayer | Regulatory Ultravist™ by Bayer now approved for contrast-enhanced mammography in EU bayer.com ↗
Bayer announced today that its iodine-based contrast agent Ultravist™-300, -370 is now approved for contrast-enhanced mammography (CEM) in the EU. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-01-23 | Bayer | Ultravist™ by Bayer now approved for contrast-enhanced mammography in EU bayer.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Iopromide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00244140 ↗ |
| Known as | Iopromida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | Proscope | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | Ultravist | “Iopromide (Ultravist 370 mg I/mL) administered intravenously” NCT00244140 ↗1“Iopromide (Ultravist 370 mg I/mL) administered intravenously” NCT00244140 ↗ |
| Known as | Ultravist (pharmacy bulk) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | Ultravist 150 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | Ultravist 240 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | Ultravist 300 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | Ultravist 370 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Known as | ZK 35760 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1725 ↗ |
| Modality | Diagnostic / imaging agent | “contrast agent called Ultravist Injection” NCT00244140 ↗ |
| Route | Other | “injection of intra-artery during cardiac interventional operation” NCT00926562 ↗ |