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FDA Medication Tracker

← All approvals · Brain & mental health · 2026

Bysanti (milsaperidone)

The FDA approved Bysanti (milsaperidone) on February 20, 2026 to treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder.
Brand name
Bysanti
Generic name
milsaperidone
FDA approval date
February 20, 2026
Approved use (FDA wording)
To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder
Company
Vanda Pharms Inc.
Application
NDA220358
Dosage form / route
TABLET · ORAL
Boxed warning on label
Yes (see the FDA label)
Category on this site
Brain & mental health

Indications and usage, from the FDA label

BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ] . BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1 , 14.2 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.