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Medical uses

Milsaperidone is indicated for the treatment of schizophrenia; and for the acute treatment of manic or mixed episodes associated with bipolar I disorder.[1]

Society and culture

Milsaperidone was approved for medical use in the United States in February 2026.[6]

Names

Milsaperidone is the international nonproprietary name.

Milsaperidone is sold under the brand name Bysanti.[6]

Research

Milsaperidone is in phase III clinical trials for treatment of major depressive disorder.[7][8]

References

  1. 1 2 3 4 “Bysanti- milsaperidone tablet; Bysanti- milsaperidone kit”. DailyMed. 27 February 2026. Retrieved 3 July 2026.
  2. ↑ “FDA Approves Milsaperidone for Treatment of Bipolar I Disorder and Schizophrenia”. Pharmacy Times. 3 March 2026. Retrieved 11 March 2026.
  3. ↑ Kang J (9 May 2025). “Milsaperidone Under Review for Bipolar I Disorder and Schizophrenia”. MPR. Retrieved 11 October 2025.
  4. 1 2 “Vanda Announces Bysanti NDA Filing; FDA Decision Expected in Early 2026”. BioSpace. 5 May 2025. Retrieved 11 October 2025.
  5. ↑ “Novel Drug Approvals for 2026”. U.S. Food and Drug Administration (FDA). 6 April 2026. Retrieved 8 April 2026.
  6. 1 2 “Vanda Pharmaceuticals Announces FDA Approval of Bysanti (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia” (Press release). Vanda Pharmaceuticals. 20 February 2026. Retrieved 8 April 2026 – via PR Newswire.
  7. ↑ IsHak WW, Hirsch D, Renteria S, Totlani J, Murphy N, Chang T, et al. (October 2025). “Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications”. BMC Psychiatry. 25 (1) 939. doi:10.1186/s12888-025-07141-3. PMC 12506068. PMID 41057811.
  8. ↑ Richmond LM (June 2025). “Med Check: FDA Accepts Bysanti Application, Cobenfy Fails as Adjunct, and More”. Psychiatric News. 60 (6) appi.pn.2025.06.6.2. doi:10.1176/appi.pn.2025.06.6.2.