Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application. Bysanti is a new chemical entity, which was initially identified as an active metabolite of iloperidone.
Vanda has discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona.
The efficacy and safety of Bysanti for the indications of bipolar I manic and mixed episodes and schizophrenia are supported by the clinical studies described on the iloperidone prescribing information. These include two studies in acute episodes of schizophrenia, one study in bipolar I disorder with manic or mixed episodes, and one relapse prevention study in schizophrenia. Bysanti is currently under development in a clinical study as a once-a-day adjunctive treatment of majorressive disorder (MDD) for patients with inadequate response on their current treatment.
Results are expected in 2026. Bysanti is eligible for 5 year regulatory data exclusivity if approved by the FDA. Current Bysanti related patent applications, if issued, would extend into the 2040's. Bysanti belongs to the class of atypical antipsychotics showing strong affinity to the alpha 1 adrenergic receptor, in addition to certain serotonin and dopamine receptors that are believed to explain its therapeutic effects.
