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Vizamyl(flutemetamol f 18)
Vizamyl (flutemetamol f 18) is a small molecule pharmaceutical. Flutemetamol f 18 was first approved as Vizamyl on 2013-10-25. It has been approved in Europe to treat alzheimer disease and radionuclide imaging.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
diagnosisD003933
mental disordersD001523
Trade Name
FDA
EMA
Vizamyl
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Flutemetamol f-18
Tradename
Company
Number
Date
Products
VIZAMYLGE HealthcareN-203137 RX2013-10-25
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
vizamylNew Drug Application2020-01-23
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Flutemetamol F-18, Vizamyl, Ge Healthcare
89161312028-09-16DP
72708002025-09-03DS, DPU-336
82362822024-05-21DS, DP
73514012023-01-24DS, DPU-336
86911852023-01-24U-336
ATC Codes
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09A: Central nervous system diagnostic radiopharmaceuticals
— V09AX: Other central nervous system diagnostic radiopharmaceuticals in atc
— V09AX04: Flutemetamol (18f)
HCPCS
No data
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03—34—613
Cognitive dysfunctionD060825G31.84—23—49
DementiaD003704F03——1—34
Healthy volunteers/patients——11——2
Normal pressure hydrocephalusD006850EFO_1001065G91.2——2——2
AtherosclerosisD050197EFO_0003914I25.1—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249—1———1
Carotid stenosisD016893—1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
AmnesiaD000647EFO_1001454F44.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CardiomyopathiesD009202EFO_0000318I421————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G20————11
Multiple system atrophyD019578————11
Lewy body diseaseD020961EFO_0006792G31.83————11
Frontotemporal dementiaD057180G31.0————11
Progressive supranuclear palsyD013494EFO_0002512G23.1————11
Frontotemporal lobar degenerationD057174————11
Primary progressive nonfluent aphasiaD057178————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUTEMETAMOL F 18
INNflutemetamol (18f)
Description
Flutemetamol ((18)F) is a member of the class of benzothiazoles that is 1,3-benzothiazole substituted by 3-((18)F)fluoro-4-(methylamino)phenyl and hydroxy groups at positions 3 and 6 respectively. 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 (18)F radiopharmaceutical, a member of benzothiazoles, an aromatic amine and a secondary amino compound.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNc1ccc(-c2nc3ccc(O)cc3s2)cc1[18F]
Identifiers
PDB—
CAS-ID765922-62-1
RxCUI1486025
ChEMBL IDCHEMBL2042122
ChEBI ID76611
PubChem CID15950376
DrugBankDB09151
UNII IDL49M066S0O (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 193 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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35 adverse events reported
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