Tauklarify Wins FDA Clearance for Tau PET Imaging in Alzheimer's Evaluation

Lantheus Holdings has received US Food and Drug Administration (FDA) approval for Tauklarify, its radiodiagnostic agent for detecting tau neurofibrillary tangles (NFTs) in adults being evaluated for Alzheimer’s disease.

Indication and mechanism
Tauklarify is indicated for positron emission tomography (PET) brain imaging in adults with cognitive impairment who are undergoing assessment for Alzheimer’s disease to identify tau NFT pathology. Tau NFTs—abnormal aggregates of the tau protein that accumulate inside neurons—are a key biomarker alongside amyloid-beta plaques in diagnosing Alzheimer’s.

Supporting clinical evidence
The FDA decision was supported by two blinded-read studies that evaluated Tauklarify PET scans from more than 500 participants, including people with mild cognitive impairment, mild Alzheimer’s disease dementia, and cognitively unimpaired individuals. Participants received an intravenous dose of approximately 185 MBq (5 mCi). Scans were read by independent, trained readers who were blinded to clinical information and amyloid-beta PET results. Readers classified scans as positive or negative for tau pathology and were compared to a pre-established reference standard based on cognitive status and amyloid-beta PET findings. The studies reported high diagnostic accuracy and strong inter-reader agreement.

Commercial and research plans
With FDA clearance secured, Lantheus said it will continue to support Alzheimer’s disease therapeutic programmes through its pharma solutions business and will evaluate the optimal path to broader commercial availability for Tauklarify. The company emphasized that rollout plans will be coordinated with partner needs and informed by ongoing developments in the Alzheimer’s treatment landscape.

Industry context
Tauklarify’s approval highlights the growing role of tau PET imaging as a complement to amyloid PET and other diagnostic tools. This approval contrasts with a parallel trend toward blood-based phosphorylated tau (pTau) tests that offer less invasive screening options. For example, Roche’s Elecsys pTau181 blood test received FDA approval in October 2025, and its pTau217 assay obtained a European CE mark in May 2026.

Therapeutic landscape
The Alzheimer’s field has recently advanced with approvals of disease-modifying therapies (DMTs), including Biogen & Eisai’s Leqembi and Eli Lilly’s Kisunla in 2023 and 2024, respectively. Despite reimbursement challenges, these agents are projected by GlobalData’s Pharmaceutical Intelligence Centre to reach blockbuster sales in the coming years. Additional developments include new efficacy and biomarker data presented by Roche for trontinemab from part of the open-label extension of the Phase Ib/IIa Brainshuttle AD study (NCT04639050) presented at the 2026 Alzheimer’s Association International Conference (AAIC) in London.

Leadership reaction
Mary Anne Heino, CEO of Lantheus, said the FDA clearance underscores the importance of tau imaging in a comprehensive Alzheimer’s evaluation and reflects the rigour of the development programme. "As the field advances, clinicians seek a fuller picture of this disease. Tau PET imaging provides complementary information to amyloid PET and other diagnostic tools, and we remain committed to research that further defines its role in understanding Alzheimer’s disease," she said.

Originally published by Pharmaceutical Technology, a GlobalData-owned brand.