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Milsaperidone, sold under the brand name Bysanti, is an atypical antipsychotic used for the treatment of schizophrenia and bipolar disorder.[1][2] It is a prodrug of iloperidone and acts as a dopamine D2 receptor and serotonin 5-HT2A receptor antagonist, among other actions.[3][4] Milsaperidone was developed by Vanda Pharmaceuticals.

Milsaperidone was approved for medical use in the United States in February 2026.[5]

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. ^ a b c https://assets.vandapharma.com/Bysanti/Prescribing_Information.pdf
  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. ^ “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. 6 April 2026. Retrieved 8 April 2026.
  6. ^ a b “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 (1 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. ISSN 0033-2704. Retrieved 11 October 2025.