FDA designation may speed new treatment for Alzheimer’s psychosis
Remlifanserin is in Phase 2/3 testing, with early results due this fall
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The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals is developing for hallucinations and delusions associated with Alzheimer’s disease psychosis.
The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy’s development and review.
“FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer’s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,” Catherine Owen Adams, CEO of Acadia, said in a company press release.
Understanding Alzheimer’s psychosis
Psychosis can involve hallucinations, such as seeing or hearing things that aren’t there, and delusions, which are fixed beliefs not based in reality. Psychosis is thought to involve imbalances in brain signaling that can cause certain nerve cells to become overly active. Altered serotonin signaling has also been linked to psychosis.
Remlifanserin is designed to reduce signaling through the serotonin 5-HT2A receptor, a brain protein involved in serotonin signaling. Acadia believes this may help restore the balance between excitatory and inhibitory brain signaling, potentially reducing hallucinations and delusions. The company is developing remlifanserin for psychosis associated with Alzheimer’s disease and Lewy body disease.
Acadia is currently conducting the Phase 2/3 RADIANT clinical trial program (NCT06159673) to test remlifanserin in people with Alzheimer’s disease psychosis. The Phase 2 study tested two doses, 30 and 60 mg, against a placebo, with the main goal of assessing their effects on a standardized measure of psychosis severity after six weeks. Based on those results, both doses or a selected dose will be evaluated against placebo in two independent Phase 3 studies.
Enrollment in the Phase 2 study is complete, and Acadia expects to announce topline results in September or October 2026. The two Phase 3 studies are already screening and enrolling adults ages 55 to 95 with Alzheimer’s disease psychosis at sites internationally.
“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,” Adams said.
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