Vanda Submits Bysanti NDA to FDA, Decision Anticipated in Early 2026

Vanda Pharmaceuticals Inc. (Vanda) announced that the US Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application.

Bysanti is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda has discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies.

The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona.

The efficacy and safety of Bysanti for the indications of bipolar I manic and mixed episodes and schizophrenia are supported by the clinical studies described on the iloperidone prescribing information. These include two studies in acute episodes of schizophrenia, one study in bipolar I disorder with manic or mixed episodes, and one relapse prevention study in schizophrenia. The safety of Bysanti is further supported by data in several thousand patients exposed to iloperidone in clinical studies, as well as the post marketing iloperidone experience, with more than 80,000 patient year exposures. The unique physical and chemical properties of milsaperidone make it amenable to the development of lipid esters that could allow the future development of long acting injectable formulations.

Bysanti is currently under development in a clinical study as a once-a-day adjunctive treatment of major depressive disorder (MDD) for patients with inadequate response on their current treatment. Results are expected in 2026.

Bysanti is eligible for 5 year regulatory data exclusivity if approved by the FDA. Current Bysanti related patent applications, if issued, would extend into the 2040's.

Bysanti belongs to the class of atypical antipsychotics showing strong affinity to the alpha 1 adrenergic receptor, in addition to certain serotonin and dopamine receptors that are believed to explain its therapeutic effects.

""The extraordinary discovery of bioequivalence to iloperidone, of this novel chemical entity, allows for the efficient development of Bysanti and opens new opportunities to further explore additional therapeutic applications of this molecule,"" said Dr. Mihael Polymeropoulos, Vanda's president, CEO and chairman of the board.

Bysanti is a new chemical entity that belongs in the class of atypical antipsychotic drugs. If approved, Bysanti could be available for sale in the US in 2026. Bysanti is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alphaadrenergic receptor, serotonin receptors and dopamine receptors. Exclusivity, including pending patent applications, could extend into the 2040s.

Vanda Pharmaceuticals Inc. is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.

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