Florbetapir (18F)

Overview

Florbetapir (18F) is a radiopharmaceutical compound containing the radionuclide fluorine-18 bound to the compound florbetapir, a molecule that binds with high affinity to beta amyloid plaque, a peptide that plays a key role in Alzheimer's Disease pathogenesis. Marketed as the product Amyvid, florbetapir 18F is 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. The radionucleide fluorine-18 was chosen as it has a half life of 110 minutes allowing it to accumulate sufficiently in the brain before undergoing positon emission decay.

Indication

Florbetapir 18F is 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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau	2024/09/19	NCT06600880	Phase 1	Not yet recruiting	Columbia University
Plasma P-tau2017 and Quantitative Amyloid PET Imaging	2021/12/20	NCT05164536	Phase 1	Completed	Invicro
Clinical Evaluation of Florbetapir in Primary Progressive Aphasia	2021/01/27	NCT04726527	N/A	Completed	Northwestern University
The Aging Brain and Cognition: Contribution of Vascular Injury, Amyloid Plaque and Tau Protein to Cognitive Dysfunction After Stroke	2020/10/19	NCT04588649	Phase 2	Completed	Chang Gung Memorial Hospital
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects	2020/07/16	NCT04474405	Early Phase 1	Completed	Avid Radiopharmaceuticals
Entire-body PET Scans for Multiple Sclerosis	2020/05/15	NCT04390009	Early Phase 1	Recruiting	Brain Health Alliance
The Influence of Vascular Burden, Amyloid Plaque and Tau Protein in Patients With Vascular Cognitive Impairment and Dementia With Tauopathy	2020/03/16	NCT04309253	Phase 2	Recruiting	Chang Gung Memorial Hospital
Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain	2017/03/15	NCT03080051	Early Phase 1	Completed	Molecular NeuroImaging
Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein	2017/03/06	NCT03071224	Early Phase 1	Completed	Invicro
Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain	2017/02/23	NCT03058965	Early Phase 1	Completed	Molecular NeuroImaging

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Amyvid	Eli Lilly and Company	0002-1200	INTRAVENOUS	51 mCi in 1 mL	6/27/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Amyvid	Eli Lilly Nederland B.V.,Papendorpseweg 83,3528 BJ Utrecht,The Netherlands	Authorised	1/14/2013

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
AMYVID 800MBQ/ML sol inyectable	Eli Lilly Nederland B.V.	112805001	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
AMYVID 1.900 MBq/ml solucion inyectable	Eli Lilly Nederland B.V.	112805004	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
AMYVID 800 MBq/ml solucion inyectable	Eli Lilly Nederland B.V.	112805002	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
AMYVID 1900MBQ/ML solucion inyectable	Eli Lilly Nederland B.V.	112805003	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not 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.

Related News

ADDF Invests $2.16 Million in Life Molecular Imaging's Novel PET Tracer for Alzheimer's Neuroinflammation

2 months ago

Life Molecular Imaging has secured $2.16 million from the Alzheimer's Drug Discovery Foundation to develop [18F]F-DED, a PET imaging agent targeting MAO-B to visualize neuroinflammation in Alzheimer's disease.

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