What Was Approved?
On February 20, 2026, the U.S. Food and Drug Administration approved Bysanti (milsaperidone) for:
- Treatment of schizophrenia in adults
- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
Bysanti is an atypical antipsychotic.
How Is Bysanti Taken?
Bysanti is taken by mouth twice daily, with or without food.
The dose is gradually increased to reduce the risk of orthostatic hypotension, or a drop in blood pressure when standing.
Recommended maintenance dosing differs depending on whether it is being used for schizophrenia or bipolar mania.
Does Bysanti Have a Boxed Warning?
Yes.
Bysanti carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis.
It is not approved for treating patients with dementia-related psychosis.
What Other Safety Issues Are Important?
The FDA-approved label includes warnings for:
- QTc interval prolongation
- Neuroleptic malignant syndrome
- Tardive dyskinesia
- High blood sugar and other metabolic changes
- Orthostatic hypotension and fainting
- Seizures
- Low white blood cell counts
- Cognitive and motor impairment
Patients may need monitoring based on their medical history and other medications.
What Are Common Side Effects?
Common adverse reactions reported in clinical studies included:
- Dizziness
- Dry mouth
- Fatigue
- Sleepiness
- Nasal congestion
- Fast heart rate
- Weight gain
- Low blood pressure
The pattern of side effects differed somewhat between schizophrenia and bipolar mania studies.
Are Drug Interactions Important?
Yes.
Some medications that strongly inhibit CYP2D6 or CYP3A4 can increase milsaperidone exposure and may require dose adjustment.
Other medicines that lower blood pressure may also increase the risk of hypotension.
Bottom Line
Bysanti (milsaperidone) is a newly FDA-approved atypical antipsychotic for adults with schizophrenia and for acute manic or mixed episodes associated with bipolar I disorder.
Because it can affect heart rhythm, blood pressure, metabolism, movement, and alertness, treatment should be individualized and monitored by a healthcare professional.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- U.S. Food and Drug Administration (FDA) — Bysanti (milsaperidone) Prescribing Information, February 2026.
- U.S. Food and Drug Administration (FDA) — Bysanti Approval Letter, February 2026.