florbetaben F18 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4818 902143-01-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • florbetaben F18
  • neuraceq
  • florbetaben (18F)
  • florbetaben F-18
Florbetaben F18 is a F18-labeled stilbene derivative, which binds to beta-amyloid plaques in the brain. The F 18 isotope produces a positron signal that is detected by a PET scanner.
  • Molecular weight: 358.44
  • Formula: C21H26FNO3
  • CLOGP: 3.94
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 39.72
  • ALOGS: -5.54
  • ROTB: 12

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 19, 2014 FDA PIRAMAL IMAGING

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V09AX06 VARIOUS
DIAGNOSTIC RADIOPHARMACEUTICALS
CENTRAL NERVOUS SYSTEM
Other central nervous system diagnostic radiopharmaceuticals
FDA MoA N0000175869 Positron Emitting Activity
FDA EPC N0000177914 Radioactive Diagnostic Agent
CHEBI has role CHEBI:37336 radioactive imaging agent

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Positron emission tomography indication 82918005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.51 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
30ML (1.4-135mCi/ML) NEURACEQ LIFE MOLECULAR N204677 March 19, 2014 RX SOLUTION INTRAVENOUS 7807135 March 18, 2029 NEURACEQ IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE P-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Amyloid beta A4 protein Unclassified Ki 8.65 CHEMBL

External reference:

IDSource
TLA7312TOI UNII
C3818757 UMLSCUI
CHEBI:79033 CHEBI
CHEMBL566752 ChEMBL_ID
11501341 PUBCHEM_CID
DB09148 DRUGBANK_ID
9184 INN_ID
1492940 RXNORM
219505 MMSL
30276 MMSL
d08254 MMSL
015462 NDDF
712736002 SNOMEDCT_US
717828005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Neuraceq HUMAN PRESCRIPTION DRUG LABEL 1 54828-001 INJECTION, SOLUTION 135 mCi INTRAVENOUS NDA 19 sections
Neuraceq HUMAN PRESCRIPTION DRUG LABEL 1 54828-001 INJECTION, SOLUTION 135 mCi INTRAVENOUS NDA 19 sections