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Acadia Pharmaceuticals Receives FDA Fast Track Designation for Remlifanserin in Alzheimer's Disease Psychosis

  • The FDA granted Fast Track designation to remlifanserin for treating hallucinations & delusions associated with Alzheimer's disease psychosis, a condition with no current FDA-approved therapies.
  • Remlifanserin is a highly selective 5-HT2A receptor inverse agonist that aims to reduce psychosis symptoms by restoring excitatory/inhibitory balance without direct dopamine blockade.
  • Enrollment for the RADIANT Phase 2 trial has been completed, with topline results expected between September & October 2026.
  • Screening & enrollment for the Phase 3 studies within the RADIANT program are currently underway.
  • Acadia Pharmaceuticals Inc. views this designation as a significant milestone addressing the unmet medical need for patients & families impacted by Alzheimer's disease psychosis.