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On February 20, 2026, the FDA approved Bysanti (milsaperidone) from Vanda Pharmaceuticals (VNDA, Nasdaq) for schizophrenia and for manic or mixed episodes associated with bipolar I disorder in adults.
Vanda describes Bysanti as a new chemical entity atypical antipsychotic that is bioequivalent to iloperidone across the therapeutic dosing spectrum, enabling use of iloperidone’s established efficacy and safety knowledge base, and more than 100,000 patient-years of real-world experience with Fanapt (iloperidone).
Vanda said it anticipates U.S. commercial availability in Q3 2026. Milsaperidone rapidly interconverts to iloperidone and provides dual active molecules, with antagonism at dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors.
Vanda CEO Mihael H. Polymeropoulos called the approval “a significant step forward” grounded in “extensive clinical heritage.”
The label warns of increased mortality in elderly patients with dementia-related psychosis.
Clinically, it adds another oral atypical antipsychotic option for schizophrenia and bipolar I mania in the labeled population.
Sources: FDA Novel Drug Approvals for 2026 ; Vanda Nasdaq post ; Bysanti ; VNDA price/performance ; Vanda Pharmaceuticals - ASCP 2025 poster on milsaperidone–iloperidone bioequivalence (PDF).
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