Lantheus Wins FDA Approval for Tau PET Agent in Alzheimer’s

Bedford, Massachusetts, August 14, 2026

TAUKLARIFY Targets Tau Pathology in Alzheimer’s

TAUKLARIFY is indicated for brain PET imaging in adults with cognitive impairment who are undergoing evaluation for Alzheimer’s disease. The agent is intended to identify tau neurofibrillary tangle pathology, a key pathological feature associated with Alzheimer’s disease. Lantheus noted that tau PET imaging can complement amyloid PET and other diagnostic tools, potentially providing clinicians and researchers with additional information about the biological characteristics of the disease. The FDA approval was supported by two blinded-read studies that evaluated TAUKLARIFY PET images from more than 500 subjects participating in three clinical trials. The study population included individuals with mild cognitive impairment, mild Alzheimer’s disease dementia, and cognitively unimpaired participants, allowing researchers to assess imaging performance across different levels of cognitive function, including earlier stages of disease. Participants received an approximate intravenous dose of 185 MBq (5 mCi) for tau PET imaging.

Clinical Evidence Supports Imaging Performance

In the first study, which included 279 subjects, positive percent agreement among independent readers ranged from 80% to 88%, while negative percent agreement ranged from 98% to 99%. Inter-reader agreement was high, with a generalized Fleiss’ kappa of 0.92. In the second study involving 338 subjects, positive percent agreement ranged from 68% to 82%, while negative percent agreement ranged from 93% to 99%, with a generalized Fleiss’ kappa of 0.86. The results supported the reproducibility of TAUKLARIFY PET image interpretation across trained independent readers. Safety was evaluated in 1,734 subjects. The most frequently reported adverse reactions occurring in at least 0.1% of participants included headache, nausea, injection-site reactions, dizziness, and abdominal discomfort. Lantheus also highlighted important limitations and precautions associated with the imaging agent. The company cautions that TAUKLARIFY performance may be lower in patients at earlier stages of the pathological spectrum. A negative scan does not necessarily exclude tau NFT pathology, while a positive scan does not necessarily confirm its presence. Additional evaluation may therefore be appropriate when clinical uncertainty remains. The approved indication also does not extend to non-Alzheimer’s disease tauopathies, for which safety and effectiveness have not been established.

New Diagnostic Tool Supports Alzheimer’s Research

The approval comes as Alzheimer’s disease research increasingly focuses on understanding distinct pathological processes, including amyloid and tau accumulation. Lantheus said it plans to continue supporting Alzheimer’s therapeutic programs through its Pharma Solutions business while evaluating the appropriate path toward broader commercial availability of TAUKLARIFY. TAUKLARIFY is subject to radiopharmaceutical-specific safety considerations, including cumulative radiation exposure. Patients are advised to hydrate before and after administration and void frequently following administration to support safe handling of the radiotracer. The prescribing information also identifies precautions involving CYP1A2 inducers, including tobacco smoking, and provides specific guidance for lactating patients. The FDA approval gives clinicians and researchers access to another tau imaging technology for Alzheimer’s disease evaluation, potentially supporting disease characterization and research into emerging therapies. With more than seven million people living with Alzheimer’s disease in the United States, tools that can help characterize underlying pathology remain important as the therapeutic landscape develops.

Source: Lantheus press relese