The FDA has approved Vanda Pharmaceuticals' Bysanti (milsaperidone), an oral drug to treat manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults.
An atypical antipsychotic, Bysanti is a new chemical entity (NCE) shown to be bioequivalent to Fanapt (iloperidone) in clinical studies, meaning it has a proven safety profile for treating serious psychiatric conditions. By rapidly interconverting to iloperidone, it creates dual-active molecules. These modulate key pathways associated with the diseases by antagonizing dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors.
Bysanti is scheduled to become commercially available in Q3 2026. In addition, Vanda is testing the drug as a once-daily adjunctive for treatment-resistant major depressive disorder in an ongoing clinical trial that should complete this year.
This is the second approval Vanda has received in recent months, the other being Nereus (tradipitant) to treat motion sickness in December of last year.