FDA approves new imaging agent for Alzheimer’s disease detection

The U.S. Food and Drug Administration approved Tauklarify (florquinitau F 18 injection) in August 2026 as a new tau PET imaging agent for adults with cognitive impairment undergoing evaluation for Alzheimer’s disease. According to FDA officials, the agent enables positron emission tomography brain scans to detect tau neurofibrillary tangle pathology, aiding clinicians in assessing suspected Alzheimer’s disease.

Tauklarify, developed by Lantheus Holdings Inc., is administered intravenously before positron emission tomography (PET) brain scans to detect tau neurofibrillary tangle (NFT) pathology in adults with cognitive impairment who are undergoing evaluation for Alzheimer’s disease, according to FDA documents released in August 2026. The FDA’s approval, announced around August 13–14, 2026, makes Tauklarify the second tau PET imaging agent authorized by the agency, following the 2020 approval of flortaucipir F 18 (Tauvid).

The radiotracer, florquinitau F 18, binds selectively to aggregated tau protein in neurofibrillary tangles, a hallmark of Alzheimer’s pathology that correlates with neuronal degeneration and symptom severity, FDA officials said.

Using fluorine-18 as the radionuclide, which has a half-life of about 110 minutes, Tauklarify can be produced centrally and distributed regionally to imaging centers, similar to other F-18 PET agents. PET scans obtained with Tauklarify are interpreted visually or quantitatively to classify the presence or absence of tau pathology based on standardized criteria established in clinical trials and labeling.

Clinical studies supporting the approval demonstrated that PET images with Tauklarify correlate with post-mortem measures of tau pathology, mirroring the evidentiary framework used for the first approved tau tracer, Tauvid. The FDA’s decision was based on prospective trials involving adults with varying degrees of cognitive impairment, from mild cognitive impairment to dementia, suspected of having Alzheimer’s disease. These trials showed a high likelihood that trained evaluators could accurately identify tau pathology from PET scans compared with neuropathology reference standards, records show.

Tauklarify is intended to be used as an adjunct to other clinical evaluations, including patient history, cognitive testing, and other imaging modalities, rather than as a stand-alone diagnostic tool, according to FDA labeling. Its role parallels that of amyloid PET tracers such as Amyvid (florbetapir F 18), Neuraceq (florbetaben F 18), and Vizamyl (flutemetamol F 18), which are approved for imaging beta-amyloid neuritic plaques. However, Tauklarify specifically targets tau pathology, a distinct hallmark of Alzheimer’s disease, providing complementary information that can aid in differential diagnosis, disease staging, and potentially treatment selection as tau- and amyloid-targeting therapies expand in clinical practice.

The FDA’s approval of Tauklarify follows the agency’s acceptance of a New Drug Application for MK-6240, the investigational tau PET imaging agent developed by Lantheus, with a targeted Prescription Drug User Fee Act (PDUFA) date in August 2026. Lantheus is a radiopharmaceutical company focused on imaging agents for disease identification and management, including Alzheimer’s disease, company records confirm.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) noted that Tauklarify’s approval “adds a second FDA-approved tau tracer alongside flortaucipir F-18 (Tauvid),” highlighting its significance for nuclear medicine and dementia imaging practice. Regulatory announcements emphasize that tau PET agents like Tauklarify are intended for use exclusively in adults with cognitive impairment undergoing evaluation for Alzheimer’s disease, with labeling designed to ensure appropriate patient selection and interpretation to avoid misuse outside the indicated population.

The approval expands clinicians’ ability to directly visualize tau pathology in vivo, enhancing diagnostic precision for patients presenting with cognitive impairment, according to experts cited by the FDA. The availability of both tau and amyloid PET imaging agents allows for a more comprehensive assessment of Alzheimer’s pathology, supporting refined diagnostic classification and potentially more tailored therapeutic strategies, especially as disease-modifying treatments targeting tau and amyloid proteins emerge in clinical practice.

Amyloid PET tracers have a longer regulatory history, with Amyvid first approved as a radioactive diagnostic agent for brain imaging of amyloid plaques. Its label indicates that a negative scan reduces the likelihood that cognitive impairment is due to Alzheimer’s disease, while a positive scan indicates moderate to frequent amyloid neuritic plaques that may also occur in other conditions. More recently, the FDA approved expanded indications for several amyloid PET agents, including an updated label for Vizamyl in June 2025, reflecting broader acceptance of PET imaging in Alzheimer’s evaluation.

Post-approval, further data collection on Tauklarify’s clinical use is expected through real-world studies and possibly post-marketing requirements, as the tracer becomes integrated into Alzheimer’s diagnostic and research workflows, FDA sources said. Adoption of tau PET imaging in routine clinical pathways will depend on factors such as reimbursement policies, access to PET imaging facilities, and clinician familiarity with interpreting tau and amyloid PET scans, industry analysts noted.