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News|Articles|September 17, 2025

Emerging Tau-Targeting Antibody for Alzheimer’s Disease Gets FDA Fast Track Designation

Author(s)Jeff Hall

Preliminary research findings have shown that the investigational anti-microtubule binding region (MTBR) tau antibody etalanetug may help reduce a biomarker for brain tau pathophysiology and tau signals on positron emission tomography (PET).

The Food and Drug Administration (FDA) has granted fast track designation to the investigational tau-targeting antibody etalanetug, which reportedly offers potential promise in suppressing tau accumulation for people with dominantly inherited Alzheimer’s disease (DIAD).

Etalanetug targets the specific tau species containing microtubule binding region (MTBR), which reportedly facilitates the spread of tau pathology to different brain regions, according to Eisai, the developer of the agent.

Preliminary findings from a phase 1/2 clinical trial show that etalanetug reduces MTBR-tau243, a cerebrospinal fluid (CSF) biomarker for brain tau pathophysiology. Eisai also pointed out this research revealed suppression of tau signals on positron emission tomography (PET), suggesting that etalanetug may inhibit tau accumulation in people with DIAD.

The company added that etalanetug is currently being assessed with lecanemab in a phase 2/3 clinical trial for patients with DIAD and a phase 2 study examining the utility of the drug for treating sporadic early AD.

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