Ioflupane i 123
Celsunax, DaTscan, Ioflupane I (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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| diagnosis | D003933 |
| mental disorders | D001523 |
Trade Name
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| datscan | New Drug Application | 2026-04-24 |
| ioflupane i 123 | ANDA | 2022-12-16 |
Indications
FDA
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Agency Specific
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Clinical
Clinical Trials
55 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 | — | G20.C | — | 1 | 3 | 2 | 4 | 9 |
| Rem sleep behavior disorder | D020187 | EFO_0007462 | G47.52 | 1 | 4 | — | 1 | 1 | 6 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | 4 | — | 1 | — | 5 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | 2 | 1 | 2 | 5 |
| Syndrome | D013577 | — | — | — | — | 2 | 1 | — | 3 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | — | 1 | 2 | 3 |
| 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 | 3 | 8 | 4 | — | 25 | 38 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | 1 | 2 | — | 5 | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 2 | 1 | 2 | — | 2 | 6 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | — | 2 | — | 1 | 3 |
| Shy-drager syndrome | D012791 | EFO_1001050 | — | — | 1 | 2 | — | 1 | 3 |
| Multiple system atrophy | D019578 | — | — | — | 1 | 2 | — | 1 | 3 |
| Movement disorders | D009069 | EFO_0004280 | G25 | — | 1 | 1 | — | 2 | 3 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | 1 | — | 1 | — | — | 2 |
| Tremor | D014202 | — | R25.1 | — | — | 1 | — | 1 | 2 |
| Atrophy | D001284 | — | — | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | 1 | — | — | — | 4 |
| Secondary parkinson disease | D010302 | EFO_1001175 | G21 | — | 3 | — | — | — | 3 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 1 | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ataxia | D001259 | — | R27.0 | — | — | — | — | 1 | 1 |
| Spinocerebellar degenerations | D013132 | — | G11 | — | — | — | — | 1 | 1 |
| Spinocerebellar ataxias | D020754 | — | — | — | — | — | — | 1 | 1 |
| Cerebellar ataxia | D002524 | — | — | — | — | — | — | 1 | 1 |
| Mobility limitation | D051346 | — | — | — | — | — | — | 1 | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 1 | 1 |
| Motor disorders | D000068079 | — | — | — | — | — | — | 1 | 1 |
| Broca aphasia | D001039 | — | — | — | — | — | — | 1 | 1 |
| Primary progressive aphasia | D018888 | EFO_0009053 | G31.01 | — | — | — | — | 1 | 1 |
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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 | — |
| ChEMBL ID | CHEMBL3989517 |
| ChEBI ID | — |
| PubChem CID | 3086674 |
| DrugBank | DB08824 |
| UNII ID | 3MM99T8R5Q (ChemIDplus, GSRS) |
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Safety
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555 adverse events reported
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