FDA approves TAUKLARIFY as new tau PET imaging agent for Alzheimer's disease evaluation
- nuaxia
- 2 days ago
- 2 min read
The approval provides clinicians with a new PET imaging agent to identify tau neurofibrillary tangle pathology in adults undergoing assessment for Alzheimer's disease, complementing existing diagnostic tools.
The US Food and Drug Administration (FDA) has approved TAUKLARIFY™ (florquinitau F 18 injection) 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.
The approval expands the availability of tau PET imaging to support Alzheimer's disease assessment, although the agent is not approved for evaluating non-Alzheimer's tauopathies.
Field | Content |
Alert Type | Drug Approval |
Drug Name | TAUKLARIFY™ (florquinitau F 18 injection) |
Indication | 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. The safety and effectiveness of TAUKLARIFY have not been established for evaluating non-Alzheimer's disease tauopathies. (Lantheus Holdings, Inc.) |
Therapy Area(s) | Neurology; Alzheimer's disease; Diagnostic Imaging |
Geography | United States (FDA) |
What Happened | On 14 August 2026, the FDA approved TAUKLARIFY, an F-18-labelled tau PET imaging agent developed by Lantheus. The radiodiagnostic is indicated for PET imaging in adults with cognitive impairment undergoing evaluation for Alzheimer's disease to identify tau NFT pathology. Approval was supported by two blinded reader studies involving more than 500 participants across three clinical trials, demonstrating high positive and negative agreement for identifying tau pathology. This represents a new approved tau PET imaging option rather than a therapeutic treatment for Alzheimer's disease. (Lantheus Holdings, Inc.) |
Why It Matters | Tau pathology is a defining feature of Alzheimer's disease and provides information that complements amyloid PET imaging and other clinical assessments. The approval gives clinicians an additional diagnostic tool to support biological assessment of Alzheimer's disease as biomarker-guided diagnosis and treatment become increasingly important. TAUKLARIFY is not intended to replace comprehensive clinical evaluation. (Lantheus Holdings, Inc.) |
Supporting Context | The pivotal studies enrolled individuals with mild cognitive impairment, mild Alzheimer's disease dementia and cognitively unimpaired participants. Independent blinded readers achieved positive percent agreement of approximately 80–88% and negative percent agreement of 98–99% in one of the pivotal studies. Lantheus stated it will continue supporting Alzheimer's therapeutic programmes while evaluating broader commercial availability. (Lantheus Holdings, Inc.) |
Key Takeaway | FDA approval establishes TAUKLARIFY as a new tau PET imaging agent for identifying Alzheimer's-related tau pathology, expanding the diagnostic tools available for evaluating cognitively impaired adults. (Lantheus Holdings, Inc.) |
What to Watch | Commercial rollout of TAUKLARIFY, its integration into Alzheimer's diagnostic pathways, and further evidence defining the role of tau PET imaging alongside emerging disease-modifying therapies. (Lantheus Holdings, Inc.) |
Primary Source | |
Relevant Date | 14 August 2026 |
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