Vanda Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for BYSANTI (milsaperidone) tablets as 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.

BYSANTI is a New Chemical Entity (NCE) classified as an atypical antipsychotic. In clinical studies, the drug demonstrated bioequivalence to iloperidone across the therapeutic dosing range, allowing it to build upon the established efficacy and safety data derived from extensive clinical development and more than 100,000 patient-years of real-world experience with Fanapt (iloperidone). The company said this positions the tablet as a novel treatment option supported by a well-characterised safety profile for serious psychiatric disorders.

Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of Vanda Pharmaceuticals, said the approval represents a significant advancement in behavioural health treatment. He noted that the therapy reflects an accelerated innovation approach aimed at addressing unmet medical needs in psychiatry.

Pharmacologically, milsaperidone rapidly interconverts to iloperidone, producing dual active molecules that antagonise dopamine D2, serotonin 5-HT2A and alpha1-adrenergic receptors. This mechanism helps modulate key neurological pathways involved in bipolar disorder and schizophrenia. The safety profile of the medication aligns closely with that previously established for iloperidone.

The drug’s receptor binding profile, including strong alpha-adrenergic binding relative to dopamine and serotonin receptor binding, may also support further investigation in conditions marked by hostility, agitation and hyperarousal.

Vanda expects BYSANTI to become commercially available in the third quarter of 2026. The therapy is anticipated to benefit from regulatory data exclusivity and issued US patents extending protection through 2044.

The approval marks Vanda’s second new drug clearance within two months, following the approval of NEREUS in December 2025.