Florbetaben f18
Neuraceq (florbetaben f18) is a small molecule pharmaceutical. Florbetaben f18 was first approved as Neuraceq on 2014-03-19.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Neuraceq
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Florbetaben f-18
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NEURACEQ | Life Molecular Imaging | N-204677 RX | 2014-03-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
neuraceq | New Drug Application | 2022-12-07 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Florbetaben F-18, Neuraceq, Life Molecular | |||
7807135 | 2029-03-18 | DS, DP | U-1497 |
HCPCS
Code | Description |
---|---|
Q9983 | Florbetaben f18, diagnostic, per study dose, up to 8.1 millicuries |
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 |
---|---|---|---|---|---|---|---|---|---|
Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | 3 | — | 1 | 8 | 15 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 1 | — | 1 | 2 | ||
Amyloidosis | D000686 | EFO_1001875 | E85 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Dementia | D003704 | F03 | 1 | — | — | — | 5 | 6 | |
Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Multiple myeloma | D009101 | C90.0 | — | — | — | — | 1 | 1 | |
Primary progressive aphasia | D018888 | EFO_0009053 | G31.01 | — | — | — | — | 1 | 1 |
Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | — | — | — | 1 | 1 |
Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | — | — | — | 1 | 1 |
Spinocerebellar ataxias | D020754 | — | — | — | — | 1 | 1 | ||
Frontotemporal lobar degeneration | D057174 | — | — | — | — | 1 | 1 | ||
Temporal lobe epilepsy | D004833 | EFO_0000773 | — | — | — | — | 1 | 1 | |
Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | — | — | — | 1 | 1 |
Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | FLORBETABEN F18 |
INN | florbetaben (18f) |
Description | Florbetaben ((18)F) is a member of the class of stilbenoids in which the para-hydrogens of stilbene are replaced by methylamino and 2-{2-[2-((18)F)fluoroethoxy]ethoxy}ethoxy) groups. 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 a stilbenoid, a substituted aniline, a secondary amino compound, a (18)F radiopharmaceutical, a polyether and an aromatic ether. |
Classification | Small molecule |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CNc1ccc(/C=C/c2ccc(OCCOCCOCC[18F])cc2)cc1 |
Identifiers
PDB | — |
CAS-ID | 902143-01-5 |
RxCUI | 1492940 |
ChEMBL ID | CHEMBL566752 |
ChEBI ID | 79033 |
PubChem CID | 11501341 |
DrugBank | DB09148 |
UNII ID | TLA7312TOI (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 174 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2 adverse events reported
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