The U S Food and Drug Administration has granted approval to Tauklarify (florquinitau F‑18 injection), a tau‑targeted PET imaging agent designed for adults undergoing evaluation for Alzheimer’s disease (AD).
Approval details and clinical evidence
The decision follows two large, independent studies that examined the tracer’s ability to detect neurofibrillary tangle (NFT) pathology. Combined, the trials evaluated scans from 617 participants, including 152 individuals with mild AD dementia, 157 with mild cognitive impairment, and 308 cognitively unimpaired subjects.
In the first study (n = 279), reader positive percent agreement ranged from 80 % to 88 %, while negative percent agreement was 98 %–99 %. The second study (n = 338) showed positive agreement between 68 % and 82 % and negative agreement from 93 % to 99 %.
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Inter‑reader reliability was strong, with Fleiss’ kappa scores of 0.92 and 0.86 in the two studies. Safety data covered 1,734 individuals; the most frequent adverse reactions were headache (0.7 %), nausea (0.2 %), injection‑site discomfort (0.1 %), dizziness (0.1 %) and abdominal discomfort (0.1 %). The label notes that the agent’s performance was measured primarily in subjects expected to have either minimal or clearly established NFT pathology, meaning accuracy may be lower in earlier disease stages.
How Tauklarify fits into Alzheimer’s diagnostics
By visualizing tau deposits, Tauklarify helps clinicians place patients on the AD continuum, especially when cognitive symptoms are subtle. The agent joins amyloid PET and emerging blood‑based biomarkers as tools for confirming disease presence and guiding therapeutic decisions. Lantheus, the manufacturer, has positioned the tracer as part of a broader effort to support ongoing clinical trials.
In a statement, Samantha Budd Haeberlein, PhD, chief medical officer of EB USA, said the imaging will “enable improved understanding of the status of Alzheimer’s disease patients across the spectrum of cognitive impairment, including those in the early stages of the disease.” The company also highlighted that Tauklarify received Fast Track designation before approval, reflecting regulatory interest in tools that may accelerate drug development.
From a practical standpoint, the new tracer could reduce diagnostic uncertainty for patients and families confronting early memory changes. When a scan shows clear tau accumulation, clinicians can more confidently attribute symptoms to AD rather than other causes, potentially speeding access to disease‑modifying therapies that are entering the market. Conversely, a negative result may prompt further evaluation, because the absence of detectable tau does not guarantee the disease is absent.
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Comparisons with existing tau agents
Separate from the studies supporting approval, additional evidence has compared Tauklarify with Tauvid (flortaucipir), the only other FDA‑approved tau PET tracer. The HEAD study, published in The Lancet in May 2026, offered head‑to‑head data.
Despite the advantages, the FDA approval carries a restriction: safety and effectiveness have not been established for non‑AD tauopathies. Clinicians must therefore apply the agent only when AD is the primary diagnostic consideration.
Regulatory timeline and next steps
The new drug application for MK‑6240 was accepted in October 2025, with a PDUFA target date of August 13 2026. At acceptance, the tracer was already involved in roughly 100 active clinical trials. Preclinical work in 2016 demonstrated high‑affinity binding to NFT‑rich cortical regions in monkeys, supporting its later human use.
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Rick Hiatt, president and CEO of EB USA, emphasized that the approval “demonstrates its ongoing commitment to be the premier developer of imaging biomarkers for neurological pathologies to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases.” Lantheus has not announced a commercial launch date but indicated that distribution will align with partner needs and evolving AD treatment options.
Patients receiving Tauklarify should be aware of radiation exposure and follow hydration and voiding recommendations to mitigate risk. The label advises avoiding CYP1A2 inducers, such as tobacco smoke, for at least a week before administration, and suggests temporary cessation of breastfeeding with appropriate milk disposal.
Radiation dose is low.