Comprehensive Report on VHX-896 (Milsaperidone/Bysanti™)

1. Executive Summary

VHX-896, known by the non-proprietary name Milsaperidone and the proposed brand name Bysanti™ (with a previous developmental code P-88), is an atypical antipsychotic medication under development by Vanda Pharmaceuticals.[1] A key characteristic of Milsaperidone is its status as an active metabolite of iloperidone, an established antipsychotic agent.[1]

The primary mechanism of action for Milsaperidone is understood to involve multi-receptor antagonism, predominantly at 5-hydroxytryptamine receptor 2A (5-HT2A) and D2 dopamine receptors (DRD2).[1] Additionally, it exhibits significant affinity for alpha-adrenergic receptors, a property that influences its overall pharmacological effects and side effect profile.[6]

Vanda Pharmaceuticals has achieved a significant regulatory milestone in the United States, having submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Milsaperidone (Bysanti™). This application seeks approval for the treatment of acute bipolar I disorder and schizophrenia.[1] The FDA has accepted the NDA for filing and has set a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026.[7]

Beyond these indications, Milsaperidone is also being evaluated in a Phase III clinical study as a once-daily adjunctive therapy for patients with major depressive disorder (MDD) who have had an inadequate response to current antidepressant treatments. Topline results from this MDD study are anticipated in 2026.[1]