FDA approves tau PET imaging agent

The F18-labeled agent is indicated for brain PET imaging to identify tau neurofibrillary tangle pathology.

By
Kathryn Wighton
August 14, 2026
2 min

MDSpire News

Overview

The FDA has approved florquinitau F18 injection (TAUKLARIFY) for tau PET imaging in adults with cognitive impairment being evaluated for Alzheimer's disease. The approval is based on two blinded read studies involving over 500 participants, demonstrating high agreement rates in tau pathology detection.

Background

The approval of TAUKLARIFY is for the diagnostic evaluation of Alzheimer's disease, particularly in identifying tau neurofibrillary tangles. Accurate imaging of tau pathology is important for understanding the disease's progression and differentiating Alzheimer's from other forms of cognitive impairment.

Data Highlights

Study	Participants	Positive Percent Agreement	Negative Percent Agreement
Study 1	279	80% - 88%	98% - 99%
Study 2	338	68% - 82%	93% - 99%

Key Findings

TAUKLARIFY is indicated for tau PET imaging in adults with cognitive impairment.
Approval supported by two blinded read studies with over 500 participants.
Positive percent agreement ranged from 68% to 88% across studies.
Negative percent agreement ranged from 93% to 99%.
Safety assessed in 1,734 participants, with low incidence of adverse effects.
Negative scans do not exclude tau pathology; results should be interpreted in context.

Clinical Implications

TAUKLARIFY is indicated for tau PET imaging in adults with cognitive impairment. The interpretation of scan results must be contextualized within the broader clinical evaluation.