Vanda Pharmaceuticals Inc. (announced that a New Drug Application (NDA) was submitted to the FDA requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.
Bysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. Bysanti™ is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors.
If approved, Bysanti™ could be available for sale in the US in 2026. Exclusivity, including pending patent applications, could extend into the 2040s. Additionally, Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026.
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