Overview
- The label carries a boxed warning against use in dementia-related psychosis and lists risks including QTc prolongation, neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes that warrant monitoring.
- Vanda describes milsaperidone as a new chemical entity that rapidly converts to iloperidone and demonstrated bioequivalence across therapeutic doses.
- U.S. commercial availability is targeted for the third quarter of 2026.
- A once-daily adjunctive study in treatment‑resistant major depressive disorder is underway with completion expected by the end of the year.
- Vanda cites expected data exclusivity and U.S. patents running to 2044, and its shares rose about 44% in after-hours trading following the announcement.