Article · Wikipedia archive · Last revised Aug 1, 2026

Milsaperidone

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

Last revised
Aug 1, 2026
Read time
≈ 2 min
Length
348 w
Citations
11
Source
Wikipedia ↗
Milsaperidone
Clinical data
Trade namesBysanti
Other namesVHX896, VHX-896
AHFS/Drugs.combysanti
License data
Routes of
administration		Oral
Drug classAtypical antipsychotic
ATC code
  • None
Legal status
Legal status
Identifiers
  • (1S)-1-[4-[3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanol
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC24H29FN2O4
Molar mass428.504 g·mol−1
3D model (JSmol)
  • C[C@@H](C1=CC(=C(C=C1)OCCCN2CCC(CC2)C3=NOC4=C3C=CC(=C4)F)OC)O
  • InChI=1S/C24H29FN2O4/c1-16(28)18-4-7-21(23(14-18)29-2)30-13-3-10-27-11-8-17(9-12-27)24-20-6-5-19(25)15-22(20)31-26-24/h4-7,14-17,28H,3,8-13H2,1-2H3/t16-/m0/s1
  • Key:SBKZGLWZGZQVHA-INIZCTEOSA-N

Milsaperidone, sold under the brand name Bysanti, is an atypical antipsychotic used for the treatment of schizophrenia and bipolar disorder.12 It is a prodrug of iloperidone and acts as a dopamine D2 receptor and serotonin 5-HT2A receptor antagonist, among other actions.34 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.78

References

References

  1. 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. "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.