FDA Grants Fast Track Designation to Emerging Tau PET Imaging Agent
Targeting tau neurofibrillary tangles, the (18F)PI-2620 agent reportedly provides promising insight into the development of three neurodegenerative conditions including Alzheimer’s disease.
A new tau positron emission tomography (PET) imaging agent that may facilitate diagnostic insights into the development of Alzheimer’s disease, progressive supranuclear palsy and corticobasal degeneration has garnered a fast track designation from the Food and Drug Administration (FDA).
The injectable (18F)PI-2620 agent, which is currently in a phase 3 trial for diagnosing tau pathology associated with Alzheimer’s disease, targets tau neurofibrillary tangles, according to Life Molecular Imaging, the developer of the PET agent.
Offering enhanced imaging of tau neurofibrillary tangles, the emerging PET agent (18F)PI-2620 has garnered fast track designation status from the FDA for detecting the progression of three neurodegenerative conditions including Alzheimer’s disease. (Images courtesy of Life Molecular Imaging.)
Emphasizing the (18F)PI-2620 agent’s combination of “robust” uptake in the brain and rapid wash-out in non-targeted brain regions, Life Molecular Imaging said the agent facilitates early detection and quantification of tau deposition in the brain.
"Receiving fast track designation from the FDA is a major milestone that highlights the promise of (18F)PI-2620 in addressing the critical need for effective diagnostic tools in Alzheimer's disease, progressive supranuclear palsy, and corticobasal degeneration," said Andrew Stephens, the chief medical officer at Life Molecular Imaging. " … We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible tau PET imaging."
Newsletter
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
The Reading Room Podcast: Current Perspectives on the Updated Appropriate Use Criteria for Brain PET
March 18th 2025In a new podcast, Satoshi Minoshima, M.D., Ph.D., and James Williams, Ph.D., share their insights on the recently updated appropriate use criteria for amyloid PET and tau PET in patients with mild cognitive impairment.
New PET Study Links Higher Education Level to Speed of Tau Accumulation with Alzheimer’s Disease
July 8th 2025For patients with amyloid β (Aβ)-positive findings on positron emission tomography, higher educational attainment was associated with accelerated accumulation and spread of tau, according to new research.
