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Florbetaben F-18

Generic Name
Florbetaben F-18
Brand Names
Neuraceq
Drug Type
Small Molecule
Chemical Formula
C21H26FNO3
CAS Number
902143-01-5
Unique Ingredient Identifier
TLA7312TOI

Overview

Florbetaben is a fluorine-18 (18F)-labeled stilbene derivative used for Positron Emission Tomography (PET) imaging of the brain. It is used for the non-invasive detection of the density of ß-amyloid neuritic plaques in the brain of adult patients with cognitive impairment.

Indication

Florbetaben is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.

Associated Conditions

  • Alzheimer's Disease (AD)
  • Cognitive Deficits

Research Report

Published: Aug 25, 2025

Florbetaben F-18 (Neuraceq®): A Comprehensive Monograph on a Key Diagnostic Agent for Amyloid Pathology

Section 1: Compound Profile and Chemical Characteristics

This section establishes the fundamental identity of Florbetaben F-18, serving as a foundational reference by detailing its nomenclature, classification, and key physicochemical properties. These characteristics are critical for understanding its biological behavior, mechanism of action, and application in positron emission tomography (PET).

1.1 Nomenclature and Identification

Florbetaben F-18 is a small molecule radiopharmaceutical recognized by a variety of names and identifiers across scientific, regulatory, and commercial domains. Its consistent identification is crucial for research, clinical practice, and regulatory oversight.

The internationally recognized generic name is Florbetaben (¹⁸F).[1] It is marketed exclusively under the brand name Neuraceq®.[3] In scientific literature and during its development phase, it was also referred to by the development codes BAY94-9172 and AV-1.[1]

From a chemical standpoint, its structure is precisely defined by the International Union of Pure and Applied Chemistry (IUPAC) systematic name: 4-[(E)-2-[2-[2-(2-($^{18}$F)fluoranylethoxy)ethoxy]ethoxy]phenyl]ethenyl]-N-methylaniline.[2] This name describes every component of the molecule, including the radioactive fluorine-18 isotope.

For database and regulatory tracking, Florbetaben F-18 is assigned several unique identifiers. The Chemical Abstracts Service (CAS) has assigned it the number 902143-01-5.[3] In the DrugBank database, it is cataloged under the accession number DB09148.[1] Other key identifiers include its Unique Ingredient Identifier (UNII) TLA7312TOI and its Chemical Entities of Biological Interest (ChEBI) ID, CHEBI:79033.[1] These identifiers ensure unambiguous reference to the specific active substance in global databases and regulatory filings.

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Life Molecular Imaging, Ltd
54828-001
INTRAVENOUS
135 mCi in 1 mL
6/13/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
NEURACEQ 300 MBq/ml solucion inyectable
113906001
SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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