Post by Drug Hunter

Milsaperidone (Bysanti®) was approved by the FDA in February 2026 for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Closely related to iloperidone (Fanapt®), milsaperidone reached the market through an unusually abbreviated development path. Because iloperidone and milsaperidone rapidly interconvert in vivo, Vanda Pharmaceuticals was able to support approval with a Ph. 1-centered bioequivalence package bridging back to iloperidone. That meant head-to-head studies in healthy volunteers and in patients with schizophrenia or bipolar I disorder were enough to help bring milsaperidone from first-in-human testing in 2021 to FDA approval in 2026. Vanda developed both compounds, making Bysanti a notable example of how metabolite pharmacology, regulatory strategy, and lifecycle management can converge in CNS drug development.