FDA Approves Lantheus Tauklarify PET for Alzheimer’s

Lantheus Holdings has received US Food and Drug Administration (FDA) approval for Tauklarify, a positron emission tomography (PET) radiodiagnostic for identifying tau neurofibrillary tangle (NFT) pathology in adults being evaluated for Alzheimer’s disease. Announced on 17 August 2026, the approval strengthens the Massachusetts-based radiopharmaceutical specialist’s Alzheimer’s diagnostic franchise and adds to a fast-maturing diagnostic ecosystem underpinning newly approved disease-modifying therapies for Alzheimer’s.

Tauklarify is indicated for PET brain imaging in adults with cognitive impairment being evaluated for Alzheimer’s, to identify tau NFT pathology. Alongside amyloid-beta plaque buildups, tau NFTs (abnormal clumps of tau protein inside brain cells) are a common biomarker for Alzheimer’s. Approval was supported by two blinded read studies analysing Tauklarify PET images from more than 500 subjects spanning mild cognitive impairment, mild Alzheimer’s dementia and cognitively unimpaired individuals, demonstrating high accuracy with strong inter-reader agreement.

Lantheus intends to continue supporting Alzheimer’s disease therapeutic programmes through its Pharma Solutions business while assessing the appropriate path toward broader commercial availability. CEO Mary Anne Heino positioned the clearance as reflecting the growing importance of tau imaging as complementary to amyloid PET and other diagnostic tools. Tauklarify represents a slight divergence from recent developments in the Alzheimer’s diagnostic space, where blood-based pTau tests have dominated (Roche’s Elecsys pTau181 FDA approval in October 2025 and pTau217 European CE mark in May 2026, alongside Beckman Coulter’s recent p-Tau217 CE mark). The approval lands as disease-modifying therapies from Biogen/Eisai (Leqembi) and Eli Lilly (Kisunla) drive rising demand for patient stratification tools.

The commercial signal is a stratifying Alzheimer’s diagnostic market where PET imaging retains a critical role alongside emerging blood-based tests. Tauklarify positions Lantheus more centrally in a therapeutic ecosystem driven by DMT reimbursement dynamics. Expect Roche Diagnostics (Elecsys), Beckman Coulter (Danaher), C2N Diagnostics (PrecivityAD), Fujirebio (Lumipulse) and Eli Lilly (via Avid Radiopharmaceuticals) to sharpen their positioning across the maturing Alzheimer’s diagnostics category.

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