Flortaucipir F-18

Overview

Flortaucipir F-18, also known as F-T807 and F-AV-1451, is a small indole molecule synthesized with a radioactive fluorine isotope. It is used as a marker in positron emission tomography (PET) imaging of patients suspected of having Alzheimer's disease. After crossing the blood-brain barrier, flortaucipir F-18 binds to aggregated tau protein, a hallmark of Alzheimer's disease whose incidence correlates well with disease progression. Although flortaucipir F-18 displays low levels of background binding throughout the brain, it does display off-target binding to monoamine oxidase MAO-A and MAO-B, as well as to regions containing high levels of melanin, neuromelanin, and iron.. It was approved by the FDA on May 28, 2020, for sale by Avid Radiopharmaceuticals under the name TAUVID™ and is the first FDA-approved molecule for imaging aggregated tau protein in the brain.

Indication

Flortaucipir F-18 is a radioactive agent indicated for positron emission tomography (PET) imaging of aggregated tau neurofibrillary tangles (NFTs) in adult patients under evaluation for Alzheimer's disease. Flortaucipir F-18 is not indicated for use in patients under evaluation for chronic traumatic encephalopathy.

Associated Conditions

Alzheimer's Disease (AD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Tau PET Outcomes with Anti-amyloid Immunotherapies	2024/12/09	NCT06723015	Phase 2	ENROLLING_BY_INVITATION	Mayo Clinic
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease	2024/03/07	NCT06297590	Phase 1	Recruiting	Eli Lilly and Company
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects	2020/07/16	NCT04474405	Early Phase 1	Completed	Avid Radiopharmaceuticals
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease	2020/07/13	NCT04468347	Phase 1	Completed	Avid Radiopharmaceuticals
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease	2019/04/03	NCT03901105	Phase 3	Completed	Avid Radiopharmaceuticals
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation	2019/04/03	NCT03901092	Phase 3	Completed	Avid Radiopharmaceuticals
Tau Screening Study in Subjects With Early Symptomatic AD	2018/03/16	NCT03467477	Phase 2	Completed	Avid Radiopharmaceuticals
Tau Screening Study in Patients With Early Symptomatic AD	2017/10/26	NCT03322462	Phase 2	Completed	Avid Radiopharmaceuticals
Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD (Alzheimer Disease) in Humans	2017/09/19	NCT03287765	N/A	Completed	Tammie L. S. Benzinger, MD, PhD
Tau PET Imaging in Atypical Dementias	2017/09/14	NCT03283449	Phase 1	Completed	University of Chicago

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Tauvid	Eli Lilly Nederland B.V.,Papendorpseweg 83,3528 BJ Utrecht,NETHERLANDS	Authorised	8/22/2024

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
No CIMA AEMPS (Spain) approvals found for this drug.

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

Next-Generation Tau Radiotracers Show Enhanced Detection of Alzheimer's Pathology

7 months ago

Two investigational radiotracers, 18F-MK6240 and 18F-PI2620, demonstrate superior binding to tau tangles compared to the FDA-approved agent 18F-Flortaucipir (TAUVID).

FDA Clears New PET Imaging Tools for Enhanced Alzheimer's Diagnosis and Monitoring

a year ago

• Siemens Healthineers' syngo.PET Cortical Analysis software gains FDA clearance for Centiloid scoring and tau PET quantification, enhancing Alzheimer's disease assessment. • Centiloid scoring standardizes amyloid plaque quantification across different PET scans, crucial for accurate diagnosis and monitoring of amyloid-targeting therapies. • Tau PET quantification, used with flortaucipir, enables clinicians to quantify tau protein tangle distribution, providing insights into disease staging and cognitive decline. • GE HealthCare's MIMneuro software also receives FDA clearance for Centiloid scaling, streamlining amyloid plaque density analysis and aiding in personalized patient care.

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