The FDA has approved milsaperidone (Bysanti, Vanda Pharmaceuticals) as first-line treatment for acute manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. 

According to a company news release, milsaperidone is a “new chemical entity” in the atypical antipsychotic class of drugs. 

Milsaperidone is the major active metabolite of iloperidone (Fanapt), which was approved for schizophrenia in 2009 and for bipolar I disorder in 2024. As such, the company was able to submit data from iloperidone clinical studies as part of the review for milsaperidone. 

The drug rapidly interconverts to iloperidone and has been shown to be bioequivalent to iloperidone across the entire approved therapeutic dose range of iloperidone, the company noted. 

The safety profile of milsaperidone aligns closely with that established for iloperidone. Both drugs come with a boxed warning that older adults with dementia-related psychosis treated with antipsychotic drugs are at an increased risk for death. Neither drug is approved for use in patients with dementia-related psychosis. 

Complete prescribing information is available online: The company said it expects the drug will be available in the third quarter of this year. 

‘An Incremental Advance’

Weighing in on this approval for Medscape Medical News, Stephen M. Strakowski, MD, professor and vice chair, Research of Psychiatry at Indiana University School of Medicine, and a professor with the Department of Community and Global Health at Indiana University in Indianapolis, Indiana, noted that milsaperidone “strongly resembles already approved iloperidone, and in fact, rapidly converts to iloperidone in vivo.”

“Consequently, although it offers another alternative, it is only an incremental advance over existing treatments,” said Strakowski, who is also professor of psychiatry and associate vice president, Regional Mental Health at Dell Medical School, University of Texas at Austin.

Beyond bipolar disorder and schizophrenia, the company is currently testing milsaperidone as a once-daily adjunctive treatment for resistant major depressive disorder.