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 mental health conditions that disrupt thinking, mood, and behavior, often causing severe distress and impaired daily functioning. Bysanti (milsaperidone) blocks key brain receptors (D2 and 5-HT2A) involved in psychosis and mood regulation while also converting to iloperidone for additional activity. This dual-action approach may help stabilize symptoms during acute episodes of mania or schizophrenia more effectively than single-target therapies.
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
