FDA Approval of Bysanti (Milsaperidone): A New Option for Bipolar I Disorder and Schizophrenia
Shyam Tailor
On February 20, 2026, the U.S. Food and Drug Administration (FDA) approved Bysanti (milsaperidone) tablets for the treatment of acute manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults, marking a significant advancement in psychiatric therapeutics.
Bysanti is designated as a new chemical entity (NCE), expanding the atypical antipsychotic class with a profile linked to decades of clinical experience through its active metabolite. This approval offers...