Drugs / Iopromide

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 · a red edge is where a trial was stopped

199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Phase 4 NCT03631771 Mar 2022 → Aug 2024 hypothyroidism GE Healthcare Withdrawn No outcome recorded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 coronary artery disorder, diabetes mellitus, impaired renal function disease GE Healthcare Withdrawn No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as iopromide ClinicalTrials.gov intervention name — accepted as the source's own label NCT00823628
7

NCT00926562

NCT00827788

NCT01580046

NCT00335101

NCT01255722

NCT00244140

NCT03631771

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