Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™ (milsaperidone) for Bipolar I Disorder and Schizophrenia
Tuesday, February 24, 2026
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has received approval from the U.S. Food and Drug Administration (FDA) for BYSANTI™ (milsaperidone) tablets. The medication is approved 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) in the class of atypical antipsychotics. Clinical studies have shown that BYSANTI™ is bioequivalent to iloperidone, allowing it to build on established efficacy and safety data from extensive clinical trials and over 100,000 patient-years of real-world experience with Fanapt® (iloperidone). This makes BYSANTI™ a new therapeutic option with a trusted safety profile for serious psychiatric conditions.
The drug is currently being evaluated as a once-daily adjunctive treatment in treatment-resistant major depressive disorder, with the ongoing study expected to complete by the end of 2026.
BYSANTI™ rapidly converts to iloperidone in the body, creating dual active molecules that antagonise dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors to modulate key pathways involved in these disorders. Its safety profile closely aligns with that of iloperidone.
The receptor binding characteristics of BYSANTI™, particularly its strong alpha-adrenergic activity relative to dopamine and serotonin receptor binding, make it suitable for further study in conditions involving hostility, agitation, and hyperarousal.
Commercial availability of BYSANTI™ is expected in the third quarter of 2026. Marketing exclusivity will be supported by regulatory data protection and U.S. patents, with the latest patent expected to expire in 2044, providing a long-term foundation for innovation and patient benefit.
BYSANTI™ represents Vanda’s second new drug approval in under two months, following the approval of NEREUS™ in December 2025.
Source: prnewswire.com
