The FDA has approved Bysanti (milsaperidone) tablets for the treatment of bipolar I disorder and schizophrenia in adults.
The drug is indicated as a first-line therapy for acute manic or mixed episodes associated with bipolar I disorder, as well as for schizophrenia, according to a Feb. 20 news release from Vanda Pharmaceuticals. Bysanti is a new chemical entity in the atypical antipsychotic class that rapidly interconverts to iloperidone, allowing it to leverage extensive clinical data and real-world safety experience tied to Vanda’s previously approved drug, Fanapt.
Vanda said the approval builds on more than 100,000 patient-years of real-world data and reflects its second FDA approval in less than two months. The company expects Bysanti to be commercially available in the third quarter of 2026.
The product’s marketing exclusivity is expected to be supported by regulatory data protections and U.S. patents extending through 2044.
