Data updated: May 26, 2026
AZEDRA (iobenguane i-131)
Oncology
Approved 2018-07-30
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-07-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
AZEDRA Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2023
Jul 2019 SUPPL
Mfg · Manufacturing (CMC)
What AZEDRA Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04614766 SPORE-3 | 202005556 P50CA174521 | Ph 1, Ph 2 | withdrawn | A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AZEDRA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.