What Was Approved?
On August 13, 2026, the U.S. Food and Drug Administration approved Tauklarify (florquinitau F 18) for positron emission tomography, or PET, imaging of the brain in certain adults with cognitive impairment who are being evaluated for Alzheimer’s disease.
The purpose of the scan is to help identify tau neurofibrillary tangle pathology, one of the abnormal brain changes associated with Alzheimer’s disease.
Is Tauklarify a Treatment for Alzheimer’s Disease?
No.
Tauklarify is a diagnostic imaging agent, not a medicine used to treat or slow Alzheimer’s disease.
It contains a radioactive tracer that is used during a PET scan to help visualize tau-related changes in the brain.
What Is Tau?
Tau is a protein normally found in nerve cells.
In Alzheimer’s disease, abnormal tau can accumulate inside brain cells and form structures called neurofibrillary tangles.
These tangles are one of the major pathological features associated with Alzheimer’s disease.
How Does Tauklarify Work?
Tauklarify contains florquinitau F 18, a radioactive imaging agent designed to bind to abnormal tau deposits in the brain.
After the tracer is given intravenously, a PET scanner detects the radioactive signal and creates images that can help clinicians assess the pattern of tau pathology.
Who Is Tauklarify Intended For?
The FDA-approved indication is for adults with cognitive impairment who are being evaluated for Alzheimer’s disease.
It is not intended as a general screening test for people without a clinical reason to be evaluated.
Can the Scan Diagnose Alzheimer’s Disease by Itself?
No.
A Tauklarify PET scan should be interpreted together with other clinical information.
The product information also warns that a negative scan does not necessarily exclude tau pathology and a positive scan does not by itself confirm Alzheimer’s disease.
Are There Limitations to Its Use?
Yes.
The safety and effectiveness of Tauklarify have not been established for evaluating non-Alzheimer’s tauopathies.
That means the scan should not automatically be used to evaluate every condition involving abnormal tau.
What Are the Main Safety Considerations?
Because Tauklarify is a radioactive diagnostic agent, patients are exposed to a small amount of ionizing radiation.
The prescribing information also identifies the potential for misinterpretation of PET images, which could contribute to an incorrect clinical assessment.
Reported adverse reactions have generally been uncommon and may include symptoms such as headache, nausea, injection-site reactions, dizziness, or abdominal discomfort.
Why Is This Approval Important?
Tau imaging can provide additional information about brain pathology in patients undergoing evaluation for Alzheimer’s disease.
The approval of Tauklarify adds another FDA-approved diagnostic tool that may help clinicians assess the presence and distribution of tau neurofibrillary tangles.
Bottom Line
Tauklarify (florquinitau F 18) is a newly approved PET imaging agent used in adults with cognitive impairment who are being evaluated for Alzheimer’s disease.
It is a diagnostic tool—not a treatment—and its results should be interpreted along with other clinical findings.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- Lantheus — Tauklarify FDA approval announcement and Prescribing Information.
- FDA Global Substance Registration System — Florquinitau F 18.