FDA approves new Alzheimer’s PET imaging agent from Lantheus

August 14, 2026 - 22:25

The U.S. Food and Drug Administration has approved a new imaging agent designed to help diagnose Alzheimer's disease in adults. The drug, sold under the brand name Tauklarify and developed by Lantheus, is a radiodiagnostic meant for use with positron emission tomography, or PET, scans. It targets tau protein tangles in the brain, which are a hallmark of the degenerative condition.

Tauklarify, also known as MK-6240, is intended for adults who are being evaluated for Alzheimer's. The tracer binds to tau deposits, allowing doctors to see their location and density on a PET scan. This can help distinguish Alzheimer's from other causes of cognitive decline, such as vascular dementia or frontotemporal disorders. The approval gives clinicians another tool beyond the existing amyloid PET scans, which detect a different protein.

The FDA's decision follows clinical trials that showed the agent reliably highlighted tau pathology in brain tissue. The most common side effects reported were mild and included headache, nausea, and injection site pain. Lantheus said the imaging agent will be available in the coming months, and it expects to ramp up production to meet demand from memory clinics and research centers.

Experts note that tau imaging is not a standalone diagnostic. A positive scan must be interpreted alongside a full neurological exam, cognitive testing, and other biomarkers. Still, the approval marks a step forward in precision diagnosis, especially as new anti-tau therapies are being tested in clinical trials. For now, Tauklarify offers a clearer picture of what is happening inside the brain, which may lead to earlier and more accurate treatment decisions.