Chemistry:Milsaperidone

From HandWiki

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. ↑ 1.0 1.1 Cite error: Invalid <ref> tag; no text was provided for refs named Bysanti FDA label
  2. ↑ "FDA Approves Milsaperidone for Treatment of Bipolar I Disorder and Schizophrenia". 3 March 2026. https://www.pharmacytimes.com/view/fda-approves-milsaperidone-for-treatment-of-bipolar-i-disorder-and-schizophrenia. 
  3. ↑ "Milsaperidone Under Review for Bipolar I Disorder and Schizophrenia". 9 May 2025. https://www.empr.com/news/milsaperidone-under-review-for-bipolar-i-disorder-and-schizophrenia/. 
  4. ↑ "Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026". 5 May 2025. https://www.biospace.com/press-releases/vanda-announces-bysanti-nda-filing-fda-decision-expected-in-early-2026. 
  5. ↑ "Novel Drug Approvals for 2026". 6 April 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026. 
  6. ↑ 6.0 6.1 "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. ↑ "Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications". BMC Psychiatry 25 (1). October 2025. doi:10.1186/s12888-025-07141-3. PMID 41057811. 
  8. ↑ "Med Check: FDA Accepts Bysanti Application, Cobenfy Fails as Adjunct, and More". Psychiatric News 60 (6). 1 June 2025. doi:10.1176/appi.pn.2025.06.6.2. ISSN 0033-2704. https://psychiatryonline.org/doi/10.1176/appi.pn.2025.06.6.2. Retrieved 11 October 2025. 




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