The FDA approved Tauklarify (florquinitau F 18 injection, formerly MK-6240) on August 14, 2026, for brain imaging of tau pathology. Tauklarify is a radioactive tracer for positron emission tomography (PET) that highlights tau tangles, twisted fibers linked to Alzheimer's disease, according to the Enigma Biomedical announcement Enigma Biomedical announcement. The approval covers adults with cognitive impairment who are being evaluated for Alzheimer's disease. This briefing explains what the scan adds for families facing impairment before age 65.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Official resources:
- Read the official notice from Marketminute — Use this primary source to verify the official announcement.
- Read the official notice from Neurologylive — Use this primary source to verify the official announcement.
Table of Contents
- What does the scan show?
- Why does tau imaging matter in younger-onset cases?
- How accurate and consistent is Tauklarify?
- What are the risks and practical steps?
What does the scan show?
The approved use identifies tau neurofibrillary tangle pathology in the brain. It includes tangles isolated to the medial temporal lobe, the memory area often affected first.
A doctor orders the injection, then PET images tau distribution. A trained reader classifies the scan as tau-positive or tau-negative. The result supports the clinical workup, it does not alone diagnose Alzheimer's disease.
Why does tau imaging matter in younger-onset cases?
Younger-onset means cognitive impairment before age 65. Atypical symptoms are more common in this group, such as language, vision, or behavior changes rather than plain memory loss.
The 2025 Alzheimer's Association-SNMMI criteria rate amyloid and tau PET as appropriate when young-onset or atypical Alzheimer's is suspected, according to the journal criteria Alzheimer's and Dementia criteria. The reason is practical accuracy: tau burden is often greater in younger patients. A clear tau result can shorten the path to a confident explanation.
How accurate and consistent is Tauklarify?
Approval rested on two studies with more than 500 participants. Five blinded readers at different centers classified each scan as positive or negative, according to the NeurologyLive report NeurologyLive report.
Positive agreement ranged from 68 percent to 88 percent. Negative agreement ranged from 93 percent to 99 percent. Interreader reliability was strong, with Fleiss kappa values of 0.92 and 0.86.
What are the risks and practical steps?
In 1,734 exposed subjects, headache occurred in 0.7 percent and nausea in 0.2 percent. Labeling also calls for radiation-safety handling, hydration and voiding advice, 7-day avoidance of CYP1A2 inducers including smoking, and 4-hour lactation interruption.
Safety and effectiveness are not established for non-Alzheimer's tauopathies. A negative scan does not exclude tau pathology, a positive scan does not prove tissue disease, and accuracy may be lower earlier in the spectrum. Enigma developed the tracer with FDA Fast Track designation and worked with Lantheus toward commercialization after its 2023 sale of Cerveau Technologies.
- Ask whether amyloid testing should come first in your clinic pathway
- Bring a full drug, supplement, smoking, and breastfeeding history
- Ask how results will change diagnosis, care, or trial referral
- Plan for hydration, voiding, and travel after the appointment
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