FDA

FDA OKs Bysanti for bipolar I disorder and schizophrenia

February 24, 2026

FDA has approved Bysanti (milsaperidone) tablets, a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.

Milsaperidone, a new chemical entity, rapidly interconverts to iloperidone, providing dual active molecules that work in tandem by antagonizing dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors to modulate key pathways in bipolar I disorder and schizophrenia.

Efficacy

Approval of Bysanti was supported through a regulatory strategy that leveraged its demonstrated bioequivalence to iloperidone. Because milsaperidone rapidly converts to iloperidone and behaves equivalently at both low and high doses, the efficacy and safety evidence from iloperidone’s development program was incorporated into the milsaperidone review framework.

Safety

Milsaperidone’s safety profile aligns closely with that established for iloperidone.

Commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) include:

• Schizophrenia: dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
• Bipolar mania: tachycardia, dizziness, dry mouth, hepatic enzymes increased, nasal congestion, weight increased, hypotension, and somnolence.

Sources:

Vanda Pharmaceuticals announces FDA approval of Bysanti (milsaperidone) for the treatment of bipolar I disorder and schizophrenia - a new chemical entity opening new horizons in psychiatric innovation. [News release]. 2026. https://vandapharmaceuticalsinc.gcs-web.com/node/16771/pdf

Bysanti (milsaperidone) [package insert]. Vanda Pharmaceuticals. https://assets.vandapharma.com/Bysanti/Prescribing_Information.pdf Revised February 2026. Accessed February 23, 2026.