Lantheus Holdings’ radiodiagnostic agent for identifying tau pathology in adult patients under evaluation for Alzheimer’s disease has secured US Food and Drug Administration (FDA) approval.
The Massachusetts-based radiopharmaceutical specialist’s Tauklarify is indicated for positron emission tomography (PET) imaging of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify tau neurofibrillary tangle (NFT) pathology.
Alongside amyloid-beta plaque buildups, tau NFTs are a common biomarker used to determine whether an individual has Alzheimer’s. Tau NFTs are abnormal clumps of tau that build up inside brain cells.
Tauklarify’s FDA approval was supported by two blinded read studies that analysed Tauklarify PET images from over 500 subjects and included individuals with mild cognitive impairment, mild Alzheimer's disease dementia, and cognitively unimpaired individuals.
All subjects across both studies received an approximate intravenous dose of 185 MBq (5 mCi) of Tauklarify, with scans analysed by independent readers who underwent training on image interpretation and were blinded to subjects' clinical information and amyloid beta PET results.
Scans were classified as positive or negative for tau NFT pathology and compared against a pre-established reference standard based on cognitive status and amyloid beta PET findings. The study demonstrated a high level of accuracy along with strong inter-reader agreement.
With FDA approval in hand, Lantheus intends to continue supporting Alzheimer’s disease therapeutic programmes through its pharma solutions business while assessing the most appropriate path towards broader commercial availability of its radiodiagnostic. The company added that its rollout approach will remain aligned with the needs of its partners and be informed by ongoing developments across the Alzheimer’s disease treatment landscape.
Lantheus’s CEO, Mary Anne Heino, highlighted that Tauklarify’s FDA clearance reflects the rising importance of tau imaging in Alzheimer’s disease assessment and the developmental programme that led to its radiodiagnostic’s clearance.
Heino continued: “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. We remain committed to advancing research that will further define the role of tau imaging in understanding Alzheimer’s disease.”
Recent developments in the Alzheimer’s space
FDA approval for Lantheus’s radiodiagnostic represents a slight divergence to recent work being done in the Alzheimer’s space, with many diagnostics for pTau evaluation in patients with cognitive impairment taking the form of blood-based tests.
Chief among these are Roche’s Elecsys tests. The company’s Elecsys pTau181, a blood-based biomarker test for the preliminary evaluation of Alzheimer’s disease, secured FDA approval in October 2025, while its pTau217 blood test for pTau measurement obtained a European CE mark in May 2026.
The broader development in the Alzheimer’s disease space, meanwhile, has been the FDA’s approval of the first disease-modifying therapies (DMT) for the disease in the form of Biogen & Eisai’s Leqembi and Eli Lilly’s Kisunla in 2023 and 2024, respectively. Despite reimbursement challenges, the drugs are both expected to become blockbuster therapies in 2027 and 2028, respectively, as per GlobalData’s Pharmaceutical Intelligence Centre.
GlobalData is the parent company of Pharmaceutical Technology.
These may soon be joined by Roche’s trontinemab, for which Roche debuted new efficacy and biomarker data from a portion of its open-label extension (OLE) segment of the Phase Ib/IIa Brainshuttle AD study (NCT04639050) at the 2026 Alzheimer’s Association International Conference (AAIC) in London last month.
