Drugs / 123I-mIBG
123I-mIBG
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | IOBENGUANE I-123 | — | 2024-12-09 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 34 trials | ||||||
| Phase 3 | NCT02043522 | Dec 2013 → Nov 2015 | coronary artery disorder, heart failure | Ottawa Heart Institute Research Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00126412 | Aug 2005 → Sep 2006 | neuroblastoma, pheochromocytoma | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT00126425 | Jul 2005 → Jul 2008 | congestive heart failure | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT00126438 | Jul 2005 → Jul 2008 | congestive heart failure | GE Healthcare | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01936649 | Aug 2013 → Feb 2014 | left ventricular failure | GE Healthcare | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01250912 | Mar 2010 → Jul 2019 | ventricular tachycardia | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00730444 | — | neuroblastoma | GE Healthcare | Approved for marketing | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT04510311 Comparator | Oct 2020 → Dec 2024 | neuroendocrine neoplasm | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00028106 Background | Dec 2001 → Jan 2007 | pheochromocytoma | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 123I-mIBG | “One dose of 10 mCi (370 mBq:± 10%, calibrated to time of injection) of 123I-mIBG (AdreView) administered as a single intravenous bolus over 1 or 2 minutes, followed by a saline flush.” NCT02043522 ↗ |
| Known as | 123I-metaiodobenzylguanidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01250912 ↗ |
| Known as | AdreView | “One dose of 10 mCi (370 mBq:± 10%, calibrated to time of injection) of 123I-mIBG (AdreView) administered as a single intravenous bolus over 1 or 2 minutes, followed by a saline flush.” NCT02043522 ↗1“A Phase 4, Open-label Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView (Iobenguane I 123 Injection)” NCT01936649 ↗ |
| Known as | Iobenguane I 123 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00730444 ↗ |
| Known as | Iobenguane I 123 Injection | “A Phase 4, Open-label Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView (Iobenguane I 123 Injection)” NCT01936649 ↗ |
| Known as | Meta-iobenzylguanidine | “123I-mIBG (Meta-iobenzylguanidine)” NCT00126412 ↗ |
| Known as | meta-iodobenzylguanidine | “123I-mIBG (meta-iodobenzylguanidine)” NCT00126438 ↗1“123I-mIBG (meta-iodobenzylguanidine)” NCT00126412 ↗ |
| Modality | Diagnostic / imaging agent | “123I-mIBG as a diagnostic imaging agent” NCT00126412 ↗ |
| Route | Intravenous | “will receive an intravenous injection” NCT00730444 ↗ |