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
Bysanti is an atypical antipsychotic drug that blocks specific receptors in the brain (D2 and 5-HT2A) to calm overactive signaling. It is a new chemical entity that rapidly converts into a second active molecule, iloperidone, providing a dual-action effect on key brain receptors. This mechanism may help stabilize mood and thinking patterns in adults with schizophrenia or acute manic episodes of bipolar I disorder.
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
