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
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.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/24 | Phase 1 | Not yet recruiting | |||
2021/01/22 | N/A | Completed | |||
2020/02/18 | Phase 1 | Completed | |||
2018/08/06 | Not Applicable | Completed | Central Hospital, Nancy, France | ||
2016/02/12 | Phase 4 | Completed | Piramal Imaging Limited |
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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/20/2014 | ||
Authorised | 2/20/2014 |
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 | Dosage Form | 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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