Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for BysantiTM (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. This marks a significant milestone for the company, as BysantiTM is a new chemical entity that rapidly interconverts to iloperidone, offering a novel therapeutic option with a trusted safety profile.
BysantiTM is expected to be commercially available in the third quarter of 2026, with marketing exclusivity protected by regulatory data exclusivity and issued U.S. patents, the latest of which is set to expire in 2044.
The approval of BysantiTM comes on the heels of Vanda's recent approval of NereusTM in December 2025, making it the second new drug approval for the company in less than two months.
Bipolar I disorder affects a significant portion of the approximately 10 million Americans with bipolar disorder, while schizophrenia impacts approximately 1% of the U.S. adult population, translating to about 2.8 million people. These conditions often result in substantial functional impairment and diminished quality of life.
BysantiTM's unique in-class receptor binding profile, characterized by strong alpha-adrenergic binding in excess of dopamine and serotonin receptor binding, positions it as a suitable candidate for further investigation in conditions that include symptoms of hostility, agitation, and hyperarousal.
The safety profile of BysantiTM aligns closely with that established for iloperidone, and the drug is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to conclude by the end of this year.
In terms of adverse reactions, commonly observed ones included dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increase. Notably, the drug is contraindicated in patients with known hypersensitivity to milsaperidone or its inactive ingredients.
Vanda Pharmaceuticals Inc. remains committed to the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients, with BysantiTM representing a major advancement in the treatment of psychiatric conditions. The market has reacted to these announcements by moving the company's shares 0.27% to a price of $7.47. For more information, read the company's full 8-K submission here.
