Bysanti (milsaperidone) is the first new FDA-approved bipolar I medication in its class in years — and it could expand options for people who haven’t responded well to existing treatments.

—The U.S. Food and Drug Administration approved a new bipolar I medication in February 2026, marking one of the more notable FDA-approved bipolar I medication additions in recent years for people who struggle through manic and mixed episodes.

The drug, Bysanti — the brand name for milsaperidone — was approved for the treatment of acute manic or mixed episodes associated with bipolar I disorder in adults. It was simultaneously approved for schizophrenia.

What makes Bysanti notable is its classification as a new chemical entity, meaning it is not a reformulation of an existing drug. According to Vanda Pharmaceuticals, the company behind the drug, Bysanti works through an active metabolite that is biologically related to iloperidone, an atypical antipsychotic sold under the brand name Fanapt that has more than 100,000 patient-years of real-world use behind it.

In clinical studies, Bysanti demonstrated bioequivalence to iloperidone across its therapeutic dosing range. That extensive track record gives clinicians a meaningful baseline for understanding how the drug is likely to behave — an advantage when introducing any new psychiatric medication.

For people living with bipolar I disorder, particularly those who have cycled through multiple medications looking for one that works without intolerable side effects, a new option matters. Treatment for bipolar disorder often involves a frustrating period of trial and error — a challenge explored in depth in our post on practical strategies for managing manic episodes, and expanding the pharmacological toolkit gives psychiatrists more tools to tailor treatment to the individual — part of a broader shift toward new tools for tracking and treating bipolar disorder.

Vanda Pharmaceuticals said it expects commercial availability of Bysanti in the third quarter of 2026. The company is also running a Phase III clinical trial evaluating Bysanti as a once-daily adjunctive treatment for treatment-resistant major depressive disorder, with results expected by the end of 2026.

Patent protection for the drug extends to 2044, suggesting Vanda is positioning Bysanti as a long-term treatment platform — not just a one-off approval.

The approval comes as researchers are making rapid progress on understanding the biology of bipolar disorder at the genetic level, raising hopes that future treatments will be more precisely targeted to the specific mechanisms driving mania and depression in each patient. For now, Bysanti represents a more immediate development: a new approved option for people managing one of psychiatry’s most challenging conditions.

Anyone considering whether Bysanti might be appropriate for their treatment should consult with a psychiatrist or prescribing physician.

For more information about bipolar I disorder and available treatments, visit NAMI’s bipolar disorder resource page or the Depression and Bipolar Support Alliance (DBSA).

Sources:
drugs.com — FDA Approves Bysanti
Psychiatric Times — FDA Approval of Bysanti