Ioflupane I-123

Overview

Ioflupane (I-123) is a radiopharmaceutical used to image dopamine neurons and diagnose Parkinsonian syndromes.

Indication

Ioflupane I-123 is a SPECT (single photon emission computerized tomography) agent used to distinguish between Parkinson’s syndrome tremors and essential tremor.

Associated Conditions

Parkinsonian Syndromes

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Idiopathic Parkinson's Progression and Dopamine Transporter SPECT	2018/05/21	NCT03531086	N/A	Completed	Julie Gurwell
Diagnostic Imaging for Clear Cell Renal Cell Carcinoma	2017/06/14	NCT03185182	Phase 2	Terminated	Region Skane
Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain	2017/02/23	NCT03058965	Early Phase 1	Completed	Molecular NeuroImaging
A Cross-Over, Multi-Center Trial to Evaluate the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes	2013/09/25	NCT01950468	Phase 3	Withdrawn	Navidea Biopharmaceuticals
Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression	2010/06/10	NCT01141023	Phase 2	Completed	Ken Marek, MD
Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia	2005/09/21	NCT00209456	Phase 3	Completed	GE Healthcare

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
DaTscan	Medi-Physics Inc. dba GE Healthcare.	17156-210	INTRAVENOUS	2 mCi in 1 mL	11/9/2022
Ioflupane I 123	Curium US LLC	69945-166	INTRAVENOUS	2 mCi in 1 mL	12/27/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Celsunax	Pinax Pharma GmbH,Lausitz Mühlenweg 5,04924 Bad Liebenwerda,Germany	Authorised	6/17/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DATSCAN SOLUTION FOR INJECTION 74 MBQ/ML	GE Healthcare B.V.	SIN15325P	INJECTION, SOLUTION	74 MBq/mL at reference time	9/4/2017

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access