FDA Grants Fast Track Designation to Remlifanserin for Alzheimer Disease Psychosis
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The FDA has granted Fast Track designation to Acadia Pharmaceuticals' remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis.
In recent news, the FDA granted Fast Track designation to remlifanserin (ACP-204; Acadia Pharmaceuticals), an investigational selective serotonin 5-HT2A receptor inverse agonist, for the treatment of hallucinations and delusions associated with Alzheimer disease psychosis (ADP).
“FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer disease psychosis, a serious condition for which there are currently no FDA-approved therapies,” Catherine Owen Adams, chief executive officer of Acadia, said in a statement. “This is an important milestone for the remlifanserin program, and we look forward to sharing upcoming topline data from the RADIANT Phase 2 trial as we continue to advance remlifanserin as a potential new treatment option for patients and families impacted by this devastating condition.”
The regulatory milestone comes as Acadia advances remlifanserin through the RADIANT development program. Enrollment in the phase 2 portion of the program has been completed, with topline results expected between September and October 2026. Screening and enrollment are also underway in several phase 3 studies as part of RADIANT’s design.
Targeting 5-HT2A Receptors in Alzheimer Disease Psychosis
Remlifanserin is being developed for hallucinations and delusions associated with AD and Lewy body–associated psychosis. Mechanistically, the investigational agent is a potent and highly selective 5-HT2A receptor inverse agonist designed to reduce psychotic symptoms without directly blocking dopamine D2 receptors.
According to Acadia, selective 5-HT2A receptor inverse agonism may address hallucinations and delusions while potentially avoiding some of the safety and tolerability concerns associated with atypical antipsychotics.
