for schizophrenia and bipolar disorder (acute treatment)
NDA· Standard Review
FDA approved Bysanti (milsaperidone) on February 20, 2026 — two weeks ahead of the Mar 5 2026 PDUFA target. Approved for acute manic/mixed episodes of bipolar I disorder and for schizophrenia in adults. Milsaperidone is a new chemical entity that rapidly interconverts to iloperidone, providing dual active molecules acting on D2/5-HT2A/α1 receptors. Commercial availability expected Q3 2026.
About
Schizophrenia and bipolar disorder are serious mental health conditions that can cause distressing symptoms like hallucinations, delusions, and severe mood swings. Bysanti (milsaperidone) is an atypical antipsychotic that works by blocking specific receptors in the brain, including dopamine and serotonin receptors, to help calm overactive signaling. This dual-action mechanism may help stabilize mood and reduce psychotic symptoms for adults experiencing acute episodes.
The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
