Overview
- Milsaperidone, the active metabolite of iloperidone, was cleared using bioequivalence data across the therapeutic range.
- The label mirrors iloperidone’s safety profile, including a boxed warning about increased mortality in older adults with dementia-related psychosis.
- Vanda plans a U.S. launch in the third quarter of 2026, with tablets offered in multiple strengths and dosed twice daily.
- Vanda’s shares rose as much as 44% in after-hours trading following the approval.
- The therapy holds new chemical entity status with patent coverage reported through 2044, and adjunctive major depressive disorder trials are underway with results expected by late 2026.