NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Jan 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
DATSCAN (ioflupane i-123) by Bayer is radiopharmaceutical activity [moa]. First approved in 2011.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DATSCAN (Ioflupane I-123) is a radioactive diagnostic agent administered intravenously to visualize dopamine transporter distribution in the brain. It is used to aid in the diagnosis of Parkinsonian syndromes and differentiate Parkinson's disease from essential tremor and other movement disorders. The radiopharmaceutical binds to dopamine transporters, enabling SPECT imaging to assess nigrostriatal dopamine neuronal integrity.
LOE Approaching
Niche diagnostic radiopharmaceutical with moderate competitive pressure (30) and declining lifecycle stage; small, specialized commercial teams focused on imaging centers and neurology.
Mechanism of Action
Radiopharmaceutical Activity
Pharmacologic Class:
Radioactive Diagnostic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Started May 2021
9 enrolled
Healthy Subjects (HS)
A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients
Started Jun 2020
172 enrolled
Parkinsonian SyndromeParkinson Disease(PD)Multiple System Atrophy (MSA)+2 more
Validation of DaTscan for Detection of Parkinson Disease Related Disorders
Started Jul 2014
20 enrolled
Parkinson DiseaseMovement Disorders
Compare Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)
Started Jul 2013
204 enrolled
Essential TremorParkinson's Disease
A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms
Started Oct 2006
273 enrolled
Parkinsonian Syndromes
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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.