NDAORALTABLET
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
4/8 — Partial
BYSANTI (milsaperidone) by Vanda Pharmaceuticals is unknown. First approved in 2026.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYSANTI (milsaperidone) is an oral atypical antipsychotic tablet approved by the FDA on February 20, 2026, developed by Vanda Pharmaceuticals. The drug's mechanism likely involves dopamine D2 and serotonin 5-HT2 receptor antagonism, with an active metabolite (P88) that mirrors the parent compound's binding profile. Specific indications have not been disclosed in the available data.
Launch17.9 years to LOE
Early-stage launch with zero competitive pressure creates opportunity for field and commercial teams to establish market position in the antipsychotic space, though team scaling will depend on payer and prescriber uptake.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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-stage launch career opportunities for commercial, medical, and market access professionals at a mid-sized specialty pharma company (Vanda). The small current job footprint (0 linked roles) reflects pre-commercial phase, but launch execution will drive hiring in field sales, managed markets, and brand management over the next 12–24 months.
Brand Manager
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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.