NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
ADREVIEW (iobenguane i-123) by GE HealthCare is (ne). First approved in 2008.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADREVIEW (Iobenguane I-123) is a radiopharmaceutical diagnostic imaging agent that mimics norepinephrine uptake in adrenergic nerve terminals. It accumulates in adrenergically innervated tissues and neural crest-derived tumors, enabling scintigraphic imaging of cardiac sympathetic innervation and neuroendocrine malignancies. The drug is administered intravenously as a solution for diagnostic assessment of myocardial innervation and detection of neuroendocrine tumors.
LOE Approaching
With LOE approaching, career growth on this product will likely focus on transition planning and optimization of existing market rather than expansion initiatives.
Mechanism of Action
(NE). Iobenguane is, therefore, largely subject to the same uptake and accumulation pathways as NE. Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles. Iobenguane accumulates in adrenergically innervated tissues such as the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
Started Dec 2015
395 enrolled
Heart Failure
Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.
Started Feb 2014
964 enrolled
Heart Failure (HF)
123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
Started Dec 2013
45 enrolled
Heart FailureCardiomyopathy
Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.
Started Aug 2013
63 enrolled
Heart Failure (HF)Ventricular Dysfunction, Left
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.