The FDA approved Tauklarify, a brain PET imaging agent, on August 14, 2026, for adults with cognitive impairment who are being evaluated for Alzheimer's disease. For people with mild cognitive impairment (MCI), it means a new diagnostic option exists, but access, pricing, and insurance coverage are not yet settled. Tauklarify is the chemical name florquinitau F 18, previously known in research as MK-6240. It is a radioactive tracer injected before a PET scan so a camera can detect tau neurofibrillary tangles, a hallmark protein buildup in Alzheimer's disease, according to Healio's coverage of the approval.
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 Healio — Use this primary source to verify the official guidance.
- Read the official guidance from Lantheus — Use this primary source to verify the official guidance.
Table of Contents
- What Tauklarify Is Approved to Do
- How Reliable Is the Scan for Someone With MCI?
- What the Scan Involves and Its Safety Profile
- Where to Get It and Who Makes It
- What Tauklarify Will Cost, and What It May Cost
- Frequently Asked Questions
What Tauklarify Is Approved to Do
Tauklarify is approved to help identify tau neurofibrillary tangle pathology in adults undergoing evaluation for Alzheimer's disease. It is only the second tau PET tracer the FDA has cleared, following Eli Lilly's Tauvid, according to Lantheus's investor release.
The pivotal trial data behind the approval included 617 subjects: 157 with mild cognitive impairment, 152 with mild Alzheimer's dementia, and 308 cognitively unimpaired participants, according to NeurologyLive's report on the approval. People with MCI were directly represented in the studies that supported approval, even though the label does not single out MCI as its own category. Safety and effectiveness have not been established for tauopathies outside Alzheimer's disease, so the scan is not a general-purpose tool for other causes of memory loss, per the same NeurologyLive report.
How Reliable Is the Scan for Someone With MCI?
Across two blinded-read studies, Tauklarify's positive agreement with the reference standard ranged from 68% to 88%, and negative agreement ranged from 93% to 99%, according to Psychiatric Times. The label specifically warns that diagnostic performance may be lower in earlier disease stages such as MCI, the same source reports.
That means a scan is less likely to return a clear-cut answer for someone whose cognitive changes are still mild, compared with someone already showing dementia-level symptoms. The label itself states that a negative scan does not necessarily rule out tau pathology, and a positive scan does not necessarily confirm it at the level a brain biopsy would, according to NeurologyLive.
- A negative result: lowers the likelihood of tau pathology but does not eliminate it
- A positive result: raises the likelihood but is not histopathological proof
- Lower accuracy expected at the MCI stage than at the dementia stage
What the Scan Involves and Its Safety Profile
Tauklarify is given by injection before the PET scan, the same way comparable tracers are administered. Among 1,734 people assessed for safety, the most common adverse reaction was headache, reported in about 0.7%, with nausea in roughly 0.2%, according to NeurologyLive and Psychiatric Times. Both rates are low, and no other adverse reaction was reported at a comparable frequency in the cited coverage.
Where to Get It and Who Makes It
Tauklarify originated as MK-6240 at Cerveau Technologies, a subsidiary of Enigma Biomedical USA. Lantheus acquired Cerveau in 2023 to finish development, and now holds the approval, according to American Pharmaceutical Review's report on the Lantheus announcement.
Lantheus said the product will be distributed through Cerveau Technologies as a Lantheus company. At the time of approval, Lantheus stated it was still assessing the path toward broader commercial availability while continuing to support Alzheimer's research through its Pharma Solutions business, according to NeurologyLive. That means nationwide access through local imaging centers was not yet confirmed as of the approval announcement, and a patient asking a memory clinic about scheduling a scan should expect availability to vary by region and roll out over time rather than being immediate everywhere.
What Tauklarify Will Cost, and What It May Cost
No source has published a Tauklarify list price, a CPT or HCPCS billing code, or a Medicare coverage decision as of the approval announcement, so reimbursement terms remain unresolved for patients and clinics for now. A patient's out-of-pocket cost, and whether insurance covers the scan at all, depends on decisions that had not been made public as of this writing.
For comparison, the only other approved tau PET tracer, Tauvid (flortaucipir F 18), carried a wholesale acquisition cost of $3,500 per 10 mCi vial under Eli Lilly's 2023 Connecticut price-disclosure filing, according to the Connecticut Disclosure Sheet for Tauvid. That figure reflects the manufacturer's wholesale cost for the drug component only, not a patient's total scan bill, which also includes the PET facility fee and physician interpretation. Until Lantheus discloses its own pricing and a billing code is assigned, this Tauvid figure is the closest reference point for the range a comparable tau tracer can carry.
Frequently Asked Questions
Can someone ask their doctor for a Tauklarify scan right now?
A doctor can discuss it, but availability depends on whether a nearby imaging center has begun offering it, since Lantheus said at approval it was still working out broader commercial distribution, per NeurologyLive.
Does a positive Tauklarify scan mean someone has Alzheimer's disease?
No. The label states a positive scan does not necessarily confirm tau pathology at the histopathological level, so it is one piece of evidence a clinician weighs, not a standalone diagnosis, per NeurologyLive.
Is Tauklarify the only tau PET scan available?
No. Eli Lilly's Tauvid was approved earlier and remains available; Tauklarify is the second FDA-approved tau PET tracer, per Lantheus's investor release.
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