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Bysanti

(Milsaperidone)

Small molecule

VVanda Pharmaceuticals

0

Indications

1

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Timeline

Expected Milestones

Q1 2028

Phase 3Recruiting

Major Depressive Disorder (MDD)

NCT06830044

Clinical

Trials by Indication[1]

Major Depressive Disorder (MDD)1 trial

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Recruiting·VVanda Pharmaceuticals·Phase 3·NCT06830044·500 enrolled

Regulatory

FDA Approval Timeline[3]

Feb 20, 2026

BYSANTI

NDA NDA220358

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Milsaperidone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Milsaperidone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA220358). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Bysanti. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Vanda Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: VVanda Pharmaceuticals

Patent Landscape[4]

Patent Cliff

Mar 28, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10570453Mar 28, 2028

10563259Jul 24, 2030

12478619May 31, 2044

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