Aug. 14, 2026 — Lantheus Holdings recently announced U.S. Food and Drug Administration (FDA) approval of Tauklarify (florquinitau F 18 injection), also referred to as MK-6240, a radiodiagnostic agent indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle (NFT) pathology. Tauklarify has a limitation of use. The safety and effectiveness of Tauklarify have not been established for the evaluation of non-Alzheimer's disease tauopathies.
“Today’s approval of Tauklarify reflects both the increasing importance of tau imaging in Alzheimer’s disease assessment and the innovative development program that supported this milestone,” said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. “As the field continues to advance, clinicians are seeking a more complete understanding of this disease, with tau PET imaging providing information that complements amyloid PET and other diagnostic tools. We remain committed to advancing research that will further define the role of tau imaging in understanding Alzheimer’s disease.”
Alzheimer’s Disease Therapeutic Programs
Following approval, Lantheus intends to continue supporting Alzheimer’s disease therapeutic programs through its Pharma Solutions business while assessing the appropriate path toward broader commercial availability. Lantheus’ approach will remain aligned with the needs of its partners and informed by developments across the Alzheimer’s disease treatment landscape.
“For clinicians and researchers, tau PET imaging is an important tool for identifying tau pathology in the brain and advancing our understanding of Alzheimer’s disease,” said Keith Johnson, Professor of Neurology and Radiology, Massachusetts, General Hospital and Harvard Medical School. “The use of sensitive quantitative tau PET imaging is essential for increasing our understanding of potential disease impacts and moving novel treatments forward.”
Tauklarify's approval is supported by two blinded read studies, Study 1 and Study 2, that analyzed Tauklarify PET images from more than 500 subjects who participated in three clinical trials. The clinical trials included individuals with mild cognitive impairment, mild Alzheimer's disease dementia and cognitively unimpaired individuals, enabling evaluation across a broad spectrum of cognitive function, including earlier stages of disease. All subjects received an approximate intravenous dose of 185 MBq (5 mCi) of Tauklarify for tau PET imaging.
In both studies,Tauklarify scans were interpreted by independent readers who underwent training on image interpretation and were blinded to subjects' clinical information and amyloid beta PET results. Scans were classified as positive or negative for tau neurofibrillary tangle (NFT) pathology and compared against a pre-established reference standard based on cognitive status and amyloid beta PET findings.
In Study 1, which analyzed images from 279 subjects, Positive Percent Agreement (PPA) across readers ranged from 80% to 88% (95% CI: 72% to 93%), and Negative Percent Agreement (NPA) ranged from 98% to 99% (95% CI: 94% to 100%). Inter-reader agreement was high, with a generalized Fleiss' kappa of 0.92, with a 95% confidence interval of 0.89 to 0.96. In Study 2, which analyzed images from 338 subjects, PPA across readers ranged from 68% to 82% (95% CI: 61% to 87%), and NPA ranged from 93% to 99% (95% CI: 89% to 100%). Inter-reader agreement was high, with a generalized Fleiss' kappa of 0.86, with a 95% confidence interval of 0.82 to 0.89.
Safety was evaluated in 1,734 subjects. The most commonly reported adverse reactions, with incidence greater than or equal to 0.1%, were headache (0.7%), nausea (0.2%), injection site reactions (0.1%), dizziness (0.1%) and abdominal discomfort (0.1%).
November 02, 2026 
