Bysanti

(Milsaperidone)

Phase 3Small molecule

VVanda Pharmaceuticals

Bysanti is one of 47 small molecule programs targeting Major Depressive Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Major Depressive DisorderRecruiting

Major Depressive DisorderPhase 3

Recruiting

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 2

Ketalar

Boehringer Ingelheim

Phase 3

3 3

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 4

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Psilocybin

COMPASS Pathways

Phase 3

11 7

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 8

Aticaprant

Johnson & Johnson

Phase 3

4 9

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

2 10

CYB003

CCybin IRL Limited

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 3Recruiting

Major Depressive Disorder

NCT06830044

Clinical

Trials by Indication[1]

Major Depressive Disorder1 trial

Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder

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

Regulatory

FDA Approval Timeline[4]

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]
Open Targets Platform — Drug–disease associations for Milsaperidone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220358). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Bysanti. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Vanda Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: VVanda Pharmaceuticals

Patent Landscape[5]

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

Bysanti

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Major Depressive Disorder1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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