FDA approves Enigma Biomedical's TAUKLARIFY for Alzheimer's disease diagnosis

Aug 14, 2026

The U.S. Food and Drug Administration approves Enigma Biomedical USA's TAUKLARIFY, a novel radiodiagnostic PET imaging agent designed to identify tau neurofibrillary tangles in adults being evaluated for Alzheimer's disease. Developed in collaboration with Lantheus, which acquired Enigma's subsidiary Cerveau Technologies in 2023, the agent demonstrates high efficacy and safety across two clinical trials involving 617 subjects, offering a critical tool for early disease detection.

TAUKLARIFY FDA approval

▪On August 14, 2026, the U.S. Food and Drug Administration approved Enigma Biomedical USA's TAUKLARIFY, a radiodiagnostic agent for positron emission tomography brain imaging in adults with cognitive impairment.
▪The U.S. Food and Drug Administration granted Fast Track designation to TAUKLARIFY to facilitate development and expedite the review of the diagnostic agent.

Tau neurofibrillary tangle imaging

▪TAUKLARIFY is indicated to identify tau neurofibrillary tangles, including those isolated to the medial temporal lobe, in adults being evaluated for Alzheimer's disease.
▪TAUKLARIFY, also known as florquinitau F 18 injection or MK-6240, is a radiodiagnostic agent designed to identify patients with tau neurofibrillary tangle pathology in the brain.

Clinical trial efficacy results

▪In Study 1 of the clinical trials, TAUKLARIFY demonstrated a positive percent agreement ranging from 80% to 88% and a negative percent agreement ranging from 98% to 99%.
▪TAUKLARIFY was evaluated in two clinical studies involving 617 subjects, including 152 with mild Alzheimer's disease dementia, 157 with mild cognitive impairment, and 308 cognitively unimpaired individuals.
▪Safety evaluations of TAUKLARIFY in 1,734 subjects showed the most common adverse reactions were headache, nausea, injection site reactions, dizziness, and abdominal discomfort.

Alzheimer's disease diagnostic applications

▪TAUKLARIFY imaging is designed to assess the status of Alzheimer's disease patients across the spectrum of cognitive impairment, including those in the early stages of the disease.
▪The safety and effectiveness of TAUKLARIFY have not been established by the U.S. Food and Drug Administration for the evaluation of non-Alzheimer's disease tauopathies.

Lantheus partnership collaboration

▪Enigma Biomedical USA and Lantheus continued to collaborate to advance product development of TAUKLARIFY leading up to its U.S. Food and Drug Administration approval.
▪In 2023, Enigma Biomedical USA sold its subsidiary, Cerveau Technologies, to Lantheus to complete the development and commercialization of the diagnostic agent TAUKLARIFY.