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

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WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (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. 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). As such BYSANTI™ represents a novel therapeutic option with a trusted safety profile in the treatment of these serious psychiatric conditions."The BYSANTI™ approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "BYSANTI™ exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health."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.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. BYSANTI™ marketing exclusivity is expected to be protected by regulatory data exclusivity and issued US patents, with the latest expiring in 2044, providing a robust foundation for long-term innovation and patient benefit.BYSANTI™ is the second new drug approval for Vanda in less than 2 months following the approval of NEREUS™ in December of 2025.About BYSANTI™To access the full Prescribing Information, including BOXED WARNING, visit www.bysanti.com.About Bipolar I Disorder and SchizophreniaBipolar 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.1 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.2345ReferencesHarvard Medical School, 2007. National Comorbidity Survey (NSC). (2017, August 21). Potkin SG, et al. Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S4-S11. doi:10.1097/JCP.0b013e3181692787. Cutler AJ, et al. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-S28. doi:10.1097/JCP.0b013e318169278d. Weiden PJ, et al. A Randomized Trial of Iloperidone for Prevention of Relapse in Schizophrenia: The REPRIEVE Study. J Clin Psychopharmacol. 2016;36(4):302-308. doi:10.1097/JCP.0000000000000516. (PMC4982888). Torres R, et al. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024;85(1):23m14966. doi:10.4088/JCP.23m14966. INDICATION AND IMPORTANT SAFETY INFORMATIONBYSANTI™ (milsaperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. BYSANTI™ is not approved for use in patients with dementia-related psychosis.CONTRAINDICATIONSKnown hypersensitivity to milsaperidone or the inactive ingredients in BYSANTI™.WARNINGS AND PRECAUTIONSCerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).QTc Interval Prolongation: may be associated with torsade de pointes and sudden death. Avoid concomitant use of BYSANTI™ with other drugs that prolong the QTc interval, and in patients with a significant risk of developing torsade de pointes; consider decreasing the BYSANTI™ dosage when prescribing BYSANTI™ with other drugs that inhibit milsaperidone metabolism or in CYP2D6 poor metabolizers. Monitor serum potassium and magnesium at baseline and during treatment in patients at risk for significant electrolyte disturbances.Neuroleptic Malignant Syndrome (NMS): If NMS is suspected, immediately discontinue BYSANTI™ and provide intensive symptomatic treatment and close monitoring.Tardive Dyskinesia: Discontinue if clinically appropriate.Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure in patients who are vulnerable to hypotension, and in those with known cardiovascular or cerebrovascular disease.Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.Leukopenia, Neutropenia, and Agranulocytosis: Patients with a pre-existing low white blood cell count (WBC) or absolute neutrophil count or a history of drug induced leukopenia or neutropenia should have frequent monitoring of their complete blood count during the first few months of BYSANTI™ therapy and should discontinue BYSANTI™ at the first sign of a decline in WBC in the absence of other causative factors. Discontinue BYSANTI™ in patients with absolute ANC

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