Sold as Azedra. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Iobenguane I-131 (sold as Azedra), first approved Jul 30, 2018, with 0 new uses approved and 0 published complete response letters.
| NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + DinutuximabNeuroblastoma · New Approaches to Neuroblastoma Therapy Consortium | Phase 2 | Not yet recruiting | Dec 3, 2025 |
| Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/ParagangliomaNeuroblastoma, Pheochromocytoma · Nanjing First Hospital, Nanjing Medical University | — | Recruiting | Sep 26, 2025 |
| MCT for the Harvard/UCSF ROBIN CenterGlioma, Childhood Brainstem, Neuroblastoma · Brigham and Women's Hospital | Not applicable | Recruiting | Aug 21, 2023 |
| Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular · Children's Oncology Group | Phase 3 | Recruiting | Apr 25, 2017 |
| Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine TumorsNeuroendocrine Tumor, Malignant, Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting · David Bushnell | Early phase 1 | Active, not recruiting | Feb 7, 2017 |
| MIBG Therapy for Patients With MIBG Avid TumorsMIBG Avid Tumors · Nationwide Children's Hospital | Phase 2 | Active, not recruiting | Mar 4, 2015 |
| Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or ParagangliomaNeuroblastoma, Pheochromocytoma · Memorial Sloan Kettering Cancer Center | Phase 2 | Recruiting | Apr 6, 2005 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 30, 2018 | AzedraNDA 209607 · New formulation or manufacturer | Progenics Pharms Inc | 2 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
