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 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYSANTI (milsaperidone) is an oral atypical antipsychotic tablet approved by FDA on February 20, 2026. The drug works through dopamine D2 and serotonin 5-HT2 receptor antagonism, with an active metabolite (P88) that maintains similar binding properties to the parent compound. Specific indications have not been disclosed in available data.
Launch17.6 years to LOE
Early-stage launch phase with zero current competitive pressure, likely requiring full commercial build-out and brand establishment team.
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 is a newly launched small-molecule product with zero current job postings, indicating either very early-stage commercialization or that Vanda Pharmaceuticals has not yet scaled public hiring. The long patent exclusivity (17.7 years) and zero competitive pressure create a greenfield opportunity for building a brand franchise from launch.
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.