Lantheus’ Tauklarify acquires FDA approval for tau PET imaging in Alzheimer’s disease
Tauklarify’s approval comes as the Alzheimer’s diagnostics field increasingly explores less invasive approaches, particularly blood-based tests for phosphorylated tau (pTau).
USA—Lantheus Holdings’ Tauklarify has received US Food and Drug Administration (FDA) approval as a radiodiagnostic agent for identifying tau pathology in adults being evaluated for Alzheimer’s disease.
The Massachusetts-based radiopharmaceutical company said Tauklarify is indicated for positron emission tomography (PET) imaging of the brain in adults with cognitive impairment who are undergoing evaluation for Alzheimer’s disease.
The imaging agent is designed to identify tau neurofibrillary tangle (NFT) pathology, one of the key biological features associated with the disease.
Alongside amyloid-beta plaques, tau NFTs are important biomarkers used in Alzheimer’s disease assessment.
Tau NFTs are abnormal accumulations of tau protein that form inside brain cells and are associated with neurodegeneration.
The FDA approval was supported by two blinded reader studies involving more than 500 participants.
The studies included people with mild cognitive impairment, mild Alzheimer’s disease dementia and cognitively unimpaired individuals.
Participants received an approximate intravenous dose of 185 MBq (5 mCi) of Tauklarify before undergoing PET scans.
Independent readers, who had received training in image interpretation, assessed the scans without access to the participants’ clinical information or amyloid-beta PET results.
The readers classified each scan as positive or negative for tau NFT pathology and compared the results with a pre-established reference standard based on cognitive status and amyloid-beta PET findings.
According to Lantheus, the studies demonstrated high diagnostic accuracy and strong agreement among readers.
Lantheus plans broader commercial availability
Following the FDA approval, Lantheus said it will continue supporting Alzheimer’s disease therapeutic programmes through its pharmaceutical solutions business while evaluating the most appropriate route for broader commercial availability of Tauklarify.
The company added that its rollout strategy will reflect the needs of its partners and developments in the Alzheimer’s disease treatment landscape.
Lantheus CEO Mary Anne Heino said the approval highlights the growing role of tau imaging in Alzheimer’s disease assessment.
“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,” Heino said.
She added that the company remains committed to research aimed at defining the role of tau imaging in Alzheimer’s disease.
Alzheimer’s diagnostics increasingly use blood tests
Tauklarify’s approval comes as the Alzheimer’s diagnostics field increasingly explores less invasive approaches, particularly blood-based tests for phosphorylated tau (pTau).
Roche’s Elecsys tests are among the leading developments in this area.
The company’s Elecsys pTau181 blood-based biomarker test for the preliminary evaluation of Alzheimer’s disease received FDA approval in October 2025, while its pTau217 blood test for measuring pTau received a European CE mark in May 2026.
Meanwhile, the treatment landscape continues to evolve following FDA approvals of the first disease-modifying therapies (DMTs) for Alzheimer’s disease.
Biogen and Eisai’s Leqembi was approved in 2023, followed by Eli Lilly’s Kisunla in 2024.
GlobalData’s Pharmaceutical Intelligence Centre expects both therapies to become blockbuster products in 2027 and 2028, respectively, despite reimbursement challenges.
Roche’s trontinemab has the potential to broaden the treatment options for Alzheimer’s disease.
The company recently presented new efficacy and biomarker data from an open-label extension of the Phase Ib/IIa Brainshuttle AD study (NCT04639050) at the 2026 Alzheimer’s Association International Conference held in London in July.
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