Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) has announced FDA approval of BYSANTI™ (milsaperidone) tablets 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 in the atypical antipsychotic class, offering patients and providers a novel therapeutic option with a trusted safety profile.
Clinical Background
BYSANTI™ demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum, leveraging more than 100,000 patient‑years of real‑world experience with Fanapt®. The drug rapidly interconverts to iloperidone, providing dual active molecules that antagonize dopamine D2, serotonin 5‑HT2A, and alpha1‑adrenergic receptors. Its receptor binding profile makes it suitable for further investigation in conditions involving hostility, agitation, and hyperarousal.
Development and Availability
The approval follows Vanda’s December 2025 approval of NEREUS™, marking the company’s second new drug approval in less than two months. BYSANTI™ is currently being tested as an adjunctive treatment in treatment‑resistant major depressive disorder, with study completion expected later this year. Commercial availability is anticipated in Q3 2026, with exclusivity protected by regulatory data and patents extending to 2044.
Indication and Safety Information
BYSANTI™ is indicated for adults with schizophrenia and for manic or mixed episodes in bipolar I disorder. The drug carries a boxed warning for increased mortality in elderly patients with dementia‑related psychosis and is not approved for use in this population. Other warnings include QTc prolongation, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, orthostatic hypotension, seizures, leukopenia, and priapism. Common adverse reactions include dizziness, dry mouth, somnolence, tachycardia, and weight gain.
About Vanda Pharmaceuticals
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) is a global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs. Its portfolio includes treatments across psychiatry, neurology, and rare diseases. For more information, visit vandapharma.com and follow @vandapharma on X.
Forward-looking information is subject to risks and uncertainties. Please read our full Disclaimer.
