The US Food and Drug Administration has approved Tauklarify, a radioactive imaging agent from Lantheus Holdings that lets doctors see one of Alzheimer’s defining features on a brain scan: clumps of tau protein.
Cleared on August 17, 2026, Tauklarify is used with positron emission tomography (PET) to image the brains of adults with cognitive impairment being evaluated for Alzheimer’s disease, helping identify tau neurofibrillary tangle (NFT) pathology — abnormal accumulations of tau protein inside brain cells. Patients receive an intravenous dose of about 185 MBq (5 mCi) before scanning.
What the data showed
Approval was supported by two blinded-read studies analyzing images from more than 500 subjects, spanning people with mild cognitive impairment, mild Alzheimer’s dementia, and cognitively unimpaired individuals. Independent readers — blinded to clinical information and to amyloid-beta PET results — classified scans as positive or negative for tau pathology, with what the company described as high accuracy and strong agreement between readers.
Why it matters
Alzheimer’s is marked by two hallmark proteins: amyloid-beta plaques and tau tangles. Amyloid PET imaging is already established, and tau imaging adds a complementary view of disease. “Tau PET imaging provides information that complements amyloid PET and other diagnostic tools,” said Lantheus CEO Mary Anne Heino. As new amyloid-targeting Alzheimer’s therapies reach patients, tools that characterize the underlying disease more precisely are becoming increasingly important.