Ioflupane i 123
DaTscan (ioflupane i 123) is a small molecule pharmaceutical. Ioflupane i 123 was first approved as Datscan on 2011-01-14. It has been approved in Europe to treat dementia, movement disorders, and radionuclide imaging.
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Commercial
Trade Name
FDA
EMA
Datscan (generic drugs available since 2022-03-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ioflupane i-123
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DATSCAN | GE Healthcare | N-022454 RX | 2011-01-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ioflupane i 123 | ANDA | 2021-12-31 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinsonian disorders | D020734 | HP_0001300 | — | — | 1 | 2 | 1 | 4 | |
| Rem sleep behavior disorder | D020187 | EFO_0007462 | G47.52 | 1 | 1 | — | 1 | — | 2 |
| Dementia | D003704 | F03 | — | — | — | 1 | 1 | 2 | |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 3 | 2 | — | 10 | 15 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | 1 | — | 2 | 4 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | — | 1 | — | 2 | 3 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | 1 | — | 1 | — | — | 2 |
| Multiple system atrophy | D019578 | — | — | 1 | — | — | 1 | ||
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | — | 1 | — | — | 1 |
| Vascular dementia | D015140 | F01 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | 1 | — | — | — | 3 | ||
| Renal cell carcinoma | D002292 | — | 1 | — | — | — | 1 | ||
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | 1 | 1 | ||
| Movement disorders | D009069 | EFO_0004280 | G25 | — | — | — | — | 1 | 1 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | IOFLUPANE I 123 |
| INN | ioflupane (123i) |
| Description | Ioflupane I(123) is an azabicycloalkane that is ecgonine methyl ester in which the N-methyl group is replaced by 3-fluoropropyl and the 3beta-hydroxy group is replaced by 4-((123)I)iodophenyl. Used for the imaging of dopamine transporters in the brain of adult patients with potential Parkinsonian Syndromes. It has a role as a radioactive imaging agent and a radiopharmaceutical. It is an azabicycloalkane, an organofluorine compound and a methyl ester. It is functionally related to an ecgonine. |
| Classification | Small molecule |
| Drug class | iodine-containing contrast media |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)[C@H]1[C@@H](c2ccc([123I])cc2)C[C@@H]2CC[C@H]1N2CCCF |
Identifiers
| PDB | — |
| CAS-ID | 155798-07-5 |
| RxCUI | 1426874 |
| ChEMBL ID | CHEMBL3989517 |
| ChEBI ID | — |
| PubChem CID | 3086674 |
| DrugBank | DB08824 |
| UNII ID | 3MM99T8R5Q (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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312 adverse events reported
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