ADREVIEW (iobenguane sulfate i-123)
AdreView is a radiopharmaceutical indicated for the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. It is also indicated for the scintigraphic assessment of myocardial sympathetic innervation in patients with NYHA Class II or III heart failure and an LVEF ≤ 35%. By calculating the heart-to-mediastinum (H/M) ratio of radioactivity uptake, AdreView helps identify patients with a lower risk of one- and two-year mortality (indicated by an H/M ratio ≥ 1.6). **Limitations of Use:** Its utility has not been established for selecting or monitoring therapeutic interventions, nor for identifying patients at high risk of death.
How ADREVIEW Works
Iobenguane is a structural analog of norepinephrine (NE) and is subject to the same uptake and accumulation pathways. It is transported into adrenergic nerve terminals via the norepinephrine transporter (NET) and stored within presynaptic storage vesicles. The agent accumulates in adrenergically innervated tissues (such as the myocardium) and neural crest-derived tumors. Labeling the molecule with the isotope Iodine-123 allows for the visualization of these tissues via gamma-scintigraphy.
Details
- Status
- Prescription
- First Approved
- 2008-09-19
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
ADREVIEW Approval History
What ADREVIEW Treats
3 indicationsADREVIEW is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pheochromocytoma
- Neuroblastoma
- Heart Failure
ADREVIEW Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01868841 | 13-039 | Ph 4 | completed | 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ADREVIEW FDA Label Details
Indications & Usage
FDA Label (PDF)ADREVIEW is indicated for the treatment of Pheochromocytoma; Neuroblastoma; Heart Failure.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.