Sold as Iobenguane Sulfate I 131. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Iobenguane Sulfate I-131 (sold as Iobenguane Sulfate I 131), first approved Mar 25, 1994, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| 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 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 25, 1994 | Iobenguane Sulfate I 131NDA 20084 · New molecular entity | Pharmalucence | 1 | 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
