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.
Background
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
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. | |||||