Longevity & AgingAlzheimer's Vaccine ALZ-101 Clears Phase 1 Safety Bar and Heads to Global Phase 2
Alzinova's experimental Alzheimer's vaccine, ALZ-101, has completed a Phase 1b trial with encouraging results and is now advancing to a global Phase 2 study. The trial reported no cases of ARIA — a serious brain-swelling side effect that has derailed other Alzheimer's immunotherapies — and produced a strong, sustained immune response, with antibodies detected directly in cerebrospinal fluid. Early signals also appeared in cognitive measures and key Alzheimer's biomarkers including P-Tau181, T-Tau, and neurofilament light. The US FDA has granted the program Fast Track designation. A companion blood-based diagnostic test is being developed with Amsterdam UMC, with first results expected later in 2026. Funding for Phase 2 is still being assembled.
