NDAORALTABLET
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
BYSANTI (milsaperidone) by Vanda Pharmaceuticals is unknown. Approved for major depressive disorder. First approved in 2026.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYSANTI (milsaperidone) is an oral atypical antipsychotic tablet approved in February 2026 for major depressive disorder. The drug is presumed to work through dopamine D2 and serotonin 5-HT2 receptor antagonism, similar to iloperidone, with an active metabolite (P88) that mirrors the parent compound's receptor profile.
Launch18.1 years to LOE
As a newly launched product entering a competitive MDD market, the brand team will focus on market penetration and clinician education against established adjunctive therapies.
Mechanism of Action
unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.
Indications (1)
Clinical Trials (1)
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Started Mar 2025
500 enrolled
Major Depressive Disorder (MDD)
Career Relevance
BYSANTI offers early-career opportunity in a launch-phase branded antipsychotic within a large, established MDD market. Success depends on rapid market capture against entrenched competitors and differentiation on safety, efficacy, or patient outcomes data.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.