On Aug. 13, 2026, FDA approved Tauklarify (florquinitau F 18) for brain PET in adults with cognitive impairment evaluated for Alzheimer disease.
The scan identifies tau neurofibrillary tangle pathology, the twisted tau deposits linked to Alzheimer's. For younger-onset families, the approval adds a second tau-imaging option to discuss with a dementia specialist. As the FDA approval listing shows, the use is specific to Alzheimer evaluation in adults with cognitive impairment (FDA approval listing).
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 FDA — Use this primary source to verify the official announcement.
- Read the official notice from Lantheus — Use this primary source to verify the official announcement.
Table of Contents
- What Tauklarify shows in an Alzheimer evaluation
- How does it fit beside the other tau tracer?
- What should younger-onset families ask before scheduling?
- What do results mean and what comes next?
What Tauklarify shows in an Alzheimer evaluation
Tau PET makes tau tangles visible during workup for cognitive impairment. Tauklarify is an F-18-labeled tracer that binds tau tangles.
It complements amyloid PET rather than replacing clinical testing. Approval was supported by two studies with more than 500 participants. In each study, five independent blinded readers rated scans as positive or negative against a cognitive plus amyloid-PET reference standard, as NeurologyLive reported (NeurologyLive approval summary).
How does it fit beside the other tau tracer?
Tauklarify is the second FDA-approved tau PET tracer. The other tracer is flortaucipir F-18 (Tauvid). Both bind tau tangles in Alzheimer evaluation.
Lantheus announced the approval on Aug. 14, 2026. The company, reporting with Enigma Biomedical USA, also calls the agent MK-6240 and describes it as an F-18-labeled tau PET radiodiagnostic (Lantheus announcement).
What should younger-onset families ask before scheduling?
The Alzheimer's Association defines younger-onset as disease in people under 65, estimated at about 200,000 Americans. Work schedules, childcare, travel to a PET center, and coverage often shape the decision.
Lantheus says it is assessing broader commercial availability and supporting drug programs through Pharma Solutions, according to SNMMI (SNMMI report). Before booking, families can ask the clinic:.
- Is Tauklarify offered at this center or by referral, and what is the wait?
- What diagnosis codes, prior authorization, and out-of-pocket costs apply?
- What medicines and supplements should be reviewed in the week before imaging?
- Who will explain tau results with amyloid and cognitive findings?
What do results mean and what comes next?
FDA labeling limits use to Alzheimer evaluation. Safety and effectiveness are not established for non-Alzheimer tauopathies. A negative scan does not exclude tau pathology, and a positive scan does not confirm it.
Safety was assessed in 1,734 subjects, with infrequent reactions. Labeling warns of misdiagnosis risk and radiation exposure, and advises avoiding CYP1A2 inducers for seven days before imaging. Bring a full medication list and ask what to pause, substitute, or continue.
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