Florbetapir f 18
Amyvid (florbetapir f 18) is a small molecule pharmaceutical. Florbetapir f 18 was first approved as Amyvid on 2012-04-06. It has been approved in Europe to treat radionuclide imaging.
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New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amyvid | New Drug Application | 2023-10-13 |
Indications
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Agency Specific
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Clinical
Clinical Trials
102 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 24 | 16 | 7 | 4 | 24 | 71 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 3 | 10 | 3 | 2 | 9 | 26 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 3 | 1 | 3 | 7 | 14 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | — | 1 | 1 | 3 |
| Sclerosis | D012598 | — | — | 1 | — | — | 1 | 1 | 3 |
| Postoperative cognitive complications | D000079690 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dementia | D003704 | EFO_0003862 | F03 | 3 | 6 | 1 | — | 7 | 15 |
| Nerve degeneration | D009410 | HP_0002180 | — | — | 1 | 1 | — | 1 | 3 |
| Cognition disorders | D003072 | — | — | — | — | 1 | — | 2 | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 3 | — | — | 2 | 7 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 3 | — | — | 2 | 6 |
| Amyloid plaque | D058225 | HP_0100256 | — | — | 3 | — | — | 1 | 4 |
| Frontotemporal dementia | D057180 | HP_0002145 | G31.0 | 1 | 2 | — | — | 1 | 4 |
| Primary progressive aphasia | D018888 | EFO_0009053 | G31.01 | 1 | 2 | — | — | 1 | 4 |
| Pick disease of the brain | D020774 | EFO_0003096 | G31.01 | 1 | 2 | — | — | 1 | 4 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | 1 | 2 | — | — | 1 | 4 |
| Chronic traumatic encephalopathy | D000070627 | — | — | 1 | 2 | — | — | 1 | 4 |
| Brain injuries | D001930 | — | S06.9 | — | 1 | — | — | 2 | 3 |
| Tauopathies | D024801 | — | — | 1 | 2 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | 4 | — | — | — | — | 4 |
| Neuroinflammatory diseases | D000090862 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Affective symptoms | D000342 | — | — | — | — | — | — | 1 | 1 |
| Aphasia | D001037 | HP_0002381 | R47.01 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Hydrocephalus | D006849 | HP_0000238 | G91 | — | — | — | — | 1 | 1 |
| Normal pressure hydrocephalus | D006850 | EFO_1001065 | G91.2 | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Florbetapir f 18 |
| INN | florbetapir (18f) |
| Description | Florbetapir F-18 is an aromatic ether consisting of a pyridine ring substituted at position 2 by a 2-{2-[2-((18)F)fluoroethoxy]ethoxy}ethoxy group and at position 5 and a 2-(4-methylaminophenyl)vinyl group. A positron emission tomography imaging ligand for the detection of amyloid aggregation associated with Alzheimer disease. It has a role as a radioactive imaging agent. It is an organofluorine compound, a member of pyridines, an aromatic ether, a (18)F radiopharmaceutical and a substituted aniline. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNc1ccc(/C=C/c2ccc(OCCOCCOCC[18F])nc2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 956103-76-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1774461 |
| ChEBI ID | 66880 |
| PubChem CID | 24822371 |
| DrugBank | — |
| UNII ID | 6W15Z5R0RU (ChemIDplus, GSRS) |
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Safety
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83 adverse events reported
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