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# FDA OKs Lantheus’ Tau PET Imaging Agent for Alzheimer’s Disease
- URL: https://www.fdaweb.com/fda-oks-lantheus-tau-pet-imaging-agent-for-alzheimers-disease/
- Published: 2026-08-14T12:00:00.000Z
- Updated: 2026-09-14T13:45:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161630

FDA has approved Lantheus Holdings’ Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease. The approval covers use of the imaging agent, also known as MK-6240, for brain positron emission tomography in adults with cognitive impairment. 

Tauklarify's approval was supported by two blinded image-read studies involving more than 500 participants from three clinical trials. The studies included people with mild cognitive impairment, mild Alzheimer’s dementia and cognitively unimpaired individuals.

In the first study, involving 279 subjects, positive percent agreement among independent readers ranged from 80% to 88%, while negative percent agreement ranged from 98% to 99%. In the second study, involving 338 subjects, positive percent agreement ranged from 68% to 82% and negative percent agreement from 93% to 99%. Inter-reader agreement was high in both studies.

Safety was evaluated in 1,734 subjects. The most frequently reported adverse reactions were headache, occurring in 0.7% of patients, nausea in 0.2%, and injection-site reactions, dizziness and abdominal discomfort in 0.1% each.