Treats schizophrenia. Sold as Bysanti. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Milsaperidone (sold as Bysanti), first approved Feb 20, 2026, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive DisorderMajor Depressive Disorder (MDD) · Vanda Pharmaceuticals | Phase 3 | Recruiting | Feb 17, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 20, 2026 | BysantiNDA 220358 · New molecular entity | Vanda Pharms Inc | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
