IOFLUPANE I-123
Ioflupane I-123 is a radioactive diagnostic agent indicated for use in adult patients as an adjunct to other diagnostic evaluations. It is utilized for striatal dopamine transporter visualization through single photon emission computed tomography (SPECT) brain imaging. The agent is specifically intended for patients with suspected Parkinsonian syndromes or suspected dementia with Lewy bodies to assist in the diagnostic process.
How IOFLUPANE I-123 Works
Ioflupane I-123 functions by binding reversibly to the human dopamine transporter (DaT), specifically concentrating in the striatum of the brain. The agent demonstrates selectivity for pre-synaptic dopamine transporters, particularly within the caudate nucleus and putamen. Following administration, the iodine-123 isotope emits gamma radiation through radioactive decay, which is detected externally by gamma detectors. This process enables the visualization of the brain striata via single photon emission computed tomography (SPECT) imaging.
Details
- Status
- Prescription
- First Approved
- 2022-03-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
IOFLUPANE I-123 Approval History
What IOFLUPANE I-123 Treats
2 indicationsIOFLUPANE I-123 is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinsonian Syndromes
- Dementia with Lewy Bodies
IOFLUPANE I-123 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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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.
IOFLUPANE I-123 FDA Label Details
Indications & Usage
IOFLUPANE I-123 is indicated for the treatment of Parkinsonian Syndromes; Dementia with Lewy Bodies.
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DATSCAN
Full clinical data, patents, trials, and competitive landscape for ioflupane i-123.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.