New NDA Submitted: Bysanti to Treat Acute Bipolar I and Schizophrenia

Eugene Ga/AdobeStock

Vanda Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) requesting marketing approval of milsaperidone (Bysanti, also known as VHX-896 and P-88) for the treatment of patients with acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti.

Bysanti is an active metabolite of iloperidone and atypical antipsychotic drug that researchers believe achieves its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, targeting 5-hydroxytryptamine receptor 2 (HTR2) and D2 dopamine receptor (DRD2).

If approved, Bysanti could be available for sale in the US in 2026. Additionally, Vanda initiated a phase 3 clinical study for Bysanti as a once-daily adjunctive treatment for major depressive disorder in the fourth quarter of 2024. Results are expected in 2026.

Stay tuned for more updates on this submission.

Reference

1. Vanda Pharmaceuticals announces the submission of an NDA to the FDA for Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia. News release. April 1, 2025. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-submission-of-an-nda-to-the-fda-for-bysanti-for-the-treatments-of-acute-bipolar-i-disorder-and-schizophrenia-302415544.html