Drugs / 131I-MIBG
131I-MIBG
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AZEDRA | — | 2018-07-30 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03044977 | May 2017 → Dec 2025 overdue | digestive system neuroendocrine neoplasm | David Bushnell | Active not recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01175356 | Dec 2011 → Sep 2016 | ganglioneuroblastoma, neuroblastoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04614766 | Sep 2022 → Apr 2024 | digestive system neuroendocrine neoplasm | David Bushnell | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00798148 | Sep 2008 → Jul 2012 | neuroblastoma | Tehran University of Medical Sciences | Unknown | No outcome recorded |
| Phase 1/2 | NCT00458952 | Apr 2007 → Jun 2009 | paraganglioma, pheochromocytoma | Molecular Insight Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07261241 | Jul 2026 → Jul 2030 expected | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03561259 | Oct 2019 → Dec 2023 | neuroblastoma | Jubilant DraxImage Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT00107289 | May 2006 → May 2027 expected | neuroblastoma, pheochromocytoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT00028106 | Dec 2001 → Jan 2007 | pheochromocytoma | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2 | NCT00013806 | — | neuroblastoma | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00037869 | Nov 2001 → Jan 2005 | metastatic neoplasm, neuroendocrine neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02961491 | — | paraganglioma, pheochromocytoma | Molecular Insight Pharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 131I-MIBG | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00798148 ↗ |
| Known as | 131I-metaiodobenzylguanidine | “131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma.” NCT00013806 ↗ |
| Known as | 131MIBG | “131MIBG is a combination of an adrenaline-like chemical and a radioactive form of iodine.” NCT00028106 ↗ |
| Known as | Azedra | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04614766 ↗ |
| Known as | Azedra Ultratrace (iobenguane I 131) | “Azedra Ultratrace (iobenguane I 131)” NCT00458952 ↗ |
| Known as | I-131 Metaiodobenzylguanidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00037869 ↗ |
| Known as | Iobenguane I-131 | “A Phase I Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma” NCT00458952 ↗ |
| Known as | iodine I 131 metaiodobenzylguanidine | “A single dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) IV over 30 minutes to 4 hours or for 15 minutes for smaller patients on day 0.” NCT00107289 ↗ |
| Known as | MIBG | “I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors” NCT00037869 ↗ |
| Action | Deplete | “This kills more tumor cells and minimizes radiation-damage to healthy tissues, like the heart and lungs.” NCT03044977 ↗ |
| Modality | Other / unclassified | “targeted radiotherapeutic agent (131)I-metaiodobenzylguanidine” PMID 26742708 ↗ Jan 2016 |
| Route | Intravenous | “The drug will be infused through a vein (intravenously, or I.V.) over 10 to 30 minutes.” NCT00028106 ↗ |