Ioflupane I-123

For Lewy bodies (DLB). Sold as Datscan. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Ioflupane I-123 (sold as Datscan), first approved Jan 14, 2011, with 1 new use approved and 0 published complete response letters.

First approved: Jan 14, 2011
Applications: 2
New uses approved: 1
Complete response letters: 0

Clinical Trials

8 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior DisorderParkinson Disease, REM Sleep Behavior Disorder · Insel Gruppe AG, University Hospital Bern	Not applicable	Recruiting	Oct 8, 2024
[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. ADParkinson Disease, Dementia With Lewy Bodies · prof. dr. Koen Van Laere	Phase 2 / Phase 3	Recruiting	Nov 7, 2023
Molecular and Functional Imaging in Monogenic PD.Parkinson Disease, Nervous System Disorder · University of Exeter	—	Recruiting	Aug 26, 2022
Terazosin and Parkinson's Disease Extension StudySymptomatic Parkinson Disease, REM Sleep Behavior Disorder · Cedars-Sinai Medical Center	Phase 2	Active, not recruiting	Nov 5, 2021
Terazosin Effect on Cardiac Changes in Early Parkinson's DiseaseREM Sleep Behavior Disorder, Pre-motor Parkinson's Disease · Cedars-Sinai Medical Center	Phase 2	Active, not recruiting	May 13, 2020
Cardiac Changes in Early Parkinson's Disease: A Follow up StudyREM Sleep Behavior Disorder, Pre-motor Parkinson Disease · Cedars-Sinai Medical Center	Phase 2	Active, not recruiting	Jan 6, 2020
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's DiseaseAlzheimer's Disease, Lewy Body Dementia · Douglas Scharre	—	Recruiting	Jan 13, 2017
DaTSCAN Imaging in Aging and Neurodegenerative DiseaseDementia, Parkinsonism · Mayo Clinic	Phase 4	Enrolling by invitation	Oct 17, 2011

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 14, 2011	DatscanNDA 22454 · New molecular entity	Ge Hlthcare Inc	5	Marketed
Mar 30, 2022	Ioflupane I-123ANDA 213792	Curium	1	Marketed

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