Vanda Pharmaceuticals Receives FDA Approval for Bysanti (Milsaperidone) for Schizophrenia and Bipolar I Disorder

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Vanda Pharmaceuticals won FDA approval for its atypical antipsychotic milsaperidone (brand name Bysanti) for frontline use in schizophrenia and manic or mixed episodes in bipolar I disorder patients3

Bysanti will be made available by the third quarter of 20263

Milsaperidone is an active metabolite of iloperidone, which forms the basis of Vanda's other psychiatric drug Fanapt, and rapidly interconverts to iloperidone after oral administration3

Vanda demonstrated that Bysanti is bioequivalent to Fanapt and supported its application with over 100,000 patient-years of clinical and real-world use data from Fanapt3

This approval comes after the FDA rejected Vanda's application for HETLIOZ (tasimelteon) for jet lag disorder in January 20263

Vanda's stock traded up nearly 40% following the Friday approval announcement3

This represents Vanda's second FDA approval in approximately two months, following the approval of Nereus for motion sickness in late 20253

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3. https://www.biospace.com/fda/vanda-rebounds-from-jet-lag-rejection-with-fda-nod-for-bipolar-schizophrenia-drug