The FDA approved Tauklarify (florquinitau F 18 injection) on August 14, 2026, a tau PET imaging agent for adults with cognitive impairment, including mild cognitive impairment, who are being evaluated for Alzheimer's disease. Developed by Cerveau Technologies and sponsored by Lantheus, it detects tau neurofibrillary tangle pathology, one of the two hallmark brain changes in Alzheimer's. For someone newly diagnosed with mild cognitive impairment, Tauklarify's approval means a second tau PET option now exists alongside the first one cleared six years earlier. Comparing the two means understanding what each test measures, how reliably readers agree on the results, and what a scan can and cannot tell a patient or their doctor.
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 guidance from Ncdhhs — Use this primary source to verify the official guidance.
- Read the official guidance from Healio — Use this primary source to verify the official guidance.
Table of Contents
- What Tauklarify Does and Who Can Get It
- How Tauklarify Compares to Tauvid, the Other Approved Tau Tracer
- How Reliable Are the Scan Results?
- What a Tauklarify Scan Cannot Tell You
- Coverage and Cost Considerations
- Frequently Asked Questions
What Tauklarify Does and Who Can Get It
Tauklarify is indicated for PET imaging of the brain in adults with cognitive impairment, including mild cognitive impairment, who are being evaluated for Alzheimer's disease, according to Lantheus's approval announcement. The scan works by binding to tau neurofibrillary tangles, clumps of abnormal protein inside brain cells that accumulate as Alzheimer's progresses, and making them visible on a PET scan.
This makes Tauklarify relevant specifically to people already flagged with cognitive impairment, not a general screening tool for healthy adults. A doctor orders the scan as part of a broader workup when Alzheimer's is suspected, typically alongside cognitive testing and sometimes amyloid imaging or blood-based biomarkers.
How Tauklarify Compares to Tauvid, the Other Approved Tau Tracer
Tauklarify is only the second FDA-approved tau PET tracer. The first, flortaucipir F-18 (Tauvid, from Eli Lilly/Avid), was approved in 2020 for the same cognitive-impairment-evaluation indication, according to the Society of Nuclear Medicine and Molecular Imaging (SNMMI). That gives clinicians, for the first time, a genuine choice between two tau agents rather than a single option.
A direct comparison already exists. The HEAD study, published in The Lancet in May 2026, scanned 775 enrolled participants with both tracers, with 682 completing both scans within 45 days across eight North American sites, according to reporting on the trial. That head-to-head design lets researchers compare how the two agents perform in the same patients rather than across separate study populations, which is the strongest basis currently available for weighing one against the other.
How Reliable Are the Scan Results?
Tauklarify's approval rested on two blinded-reader studies covering 617 people: 152 with mild Alzheimer's dementia, 157 with mild cognitive impairment, and 308 cognitively unimpaired participants, according to Practical Neurology. Five independent readers per study rated each scan as positive or negative without knowing the patient's clinical status. Agreement among those readers ranged from 80% to 88% in the first study and 68% to 82% in the second, with high consistency between readers (a statistical measure called Fleiss kappa of 0.92 and 0.86 in the two studies), according to Healio.
That means different radiologists reading the same scan usually reach the same conclusion, though not always — a gap worth asking about if a result seems inconsistent with other clinical findings. On safety, headache was the most common side effect among 1,734 people evaluated, reported in 0.7% of cases, per the same Healio summary. No other adverse reaction stood out in the approval data.
What a Tauklarify Scan Cannot Tell You
The label carries an explicit limitation: a positive or negative Tauklarify scan does not by itself confirm or rule out tau pathology, according to Healio's summary of the prescribing information. Safety and effectiveness have also not been established for tauopathies other than Alzheimer's, meaning the scan is validated for this one disease context and not for other conditions that also involve tau buildup.
This caveat applies to Tauvid as well, since both scans share the same basic interpretive limits. A reader considering either test should treat the result as one piece of evidence that a doctor weighs alongside cognitive testing, other imaging, and clinical judgment, not as a standalone diagnosis.
- Tauklarify and Tauvid are both approved only for adults already showing cognitive impairment, not for predicting future risk in people without symptoms.
- A positive scan indicates tau pathology is present but does not confirm Alzheimer's disease on its own.
- Ask whether the ordering physician is using the scan to support a diagnosis already suspected from other testing, since that is the approved use.
Coverage and Cost Considerations
Pricing and insurance coverage specifically for Tauklarify were not published alongside the approval. Tauvid offers a reference point: it has historically been billed under a non-covered PET code (G0235) while awaiting Medicare guidance, according to North Carolina Medicaid coverage documentation.
That history suggests out-of-pocket cost and coverage for tau PET generally can vary by imaging site and insurance payer. Anyone considering either scan should ask their imaging center directly about current billing codes and expected out-of-pocket cost before scheduling, since national coverage policy for Tauklarify specifically had not been finalized as of its approval.
Frequently Asked Questions
Is Tauklarify a replacement for Tauvid?
No. Both remain FDA-approved tau PET tracers for the same indication, giving doctors a choice rather than one replacing the other, per SNMMI.
Can a Tauklarify scan diagnose Alzheimer's by itself?
No. The label states a positive or negative result does not by itself confirm or rule out tau pathology, so it supports rather than replaces a full clinical evaluation, according to Healio.
Who is eligible for Tauklarify imaging?
Adults with cognitive impairment, including mild cognitive impairment, being evaluated for Alzheimer's disease, per Lantheus.
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