FDA Approves Vanda's BYSANTI for Bipolar I Disorder and Schizophrenia
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
The U.S. Food and Drug Administration 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. The approval marks the second new drug approval for Vanda Pharmaceuticals in less than 2 months, following the December 2025 approval of NEREUS for the prevention of motion-induced vomiting.
BYSANTI is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In clinical studies BYSANTI demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum enabling it to leverage well-established knowledge of efficacy and safety derived from a rich clinical development program and more than 100,000 patient-years of real-world experience with Fanapt (iloperidone).
BYSANTI (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 these disorders. Its safety profile aligns closely with that established for iloperidone.
BYSANTI's unique in-class receptor binding profile, featuring strong alpha-adrenergic binding in excess of dopamine and serotonin receptor binding, makes it suitable for further investigation in conditions that include symptoms of hostility, agitation, and hyperarousal.
Vanda anticipates commercial availability of BYSANTI in Q3 of 2026. The drug is expected to be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, supporting long-term innovation and patient benefits.
A phase 3 trial evaluating BYSANTI for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is underway, with results expected this year. BYSANTI is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to complete by the end of this year.
Bipolar I disorder impacts a significant portion of the roughly 10 million Americans with bipolar disorder, characterized by manic or mixed episodes that require effective symptom management to enhance outcomes. Schizophrenia affects approximately 1% of the U.S. adult population (about 2.8 million people), often causing substantial functional impairment, frequent hospitalizations, and diminished quality of life.
Shares of Vanda Pharmaceuticals were up over 40% in after-hours trading on Friday, following the regulatory update. The stock closed Friday's trading at $5.76, down 5.57%. In after-hours, shares were up over 40% at $8.30. The stock has traded in a range of $3.81 to $9.60 in the last 1 year.