FDA Approves Vanda's Bysanti for Schizophrenia and Bipolar I Disorder

Vanda Pharmaceuticals won the FDA's approval for its atypical antipsychotic milsaperidone on Friday, opening up the drug's frontline use for schizophrenia and manic or mixed episodes in patients with bipolar I disorder. The drug will carry the brand name Bysanti.

Vanda will make Bysanti available by the third quarter of this year. The pharma was trading at $8.05 apiece before the opening bell on Monday, up nearly 40% from its closing price of $5.76 on Friday.

Milsaperidone, Bysanti's main ingredient, is an active metabolite of iloperidone, which forms the basis of Vanda's other psychiatric drug Fanapt. Like Bysanti, Fanapt is indicated for schizophrenia and manic and mixed episodes in bipolar disorder. After being taken orally, Bysanti "rapidly interconverts to iloperidone," which blocks the dopamine D2, serotonin 5-HT2A and alpha1-adrenergic receptors.

The company has demonstrated that Bysanti is bioequivalent to Fanapt. Pharmacokinetic data presented in May last year show that levels of both drugs follow similar trajectories over time. Clinical studies have demonstrated bioequivalence between milsaperidone and iloperidone across dosing ranges, supporting its potential as a once-daily oral therapy.

Aside from bioequivalence data, Vanda also supported Bysanti's application with the "well-established knowledge of efficacy and safety" of Fanapt, covering more than 100,000 patient-years of clinical and real-world use. Bysanti offers "patients and providers a reliable new treatment grounded in extensive clinical heritage," the CEO said in a statement.

Pharmacologically, Bysanti is classified as an atypical antipsychotic, with strong binding affinity to alpha-1 adrenergic receptor as well as serotonin and dopamine receptors - interactions thought to drive its therapeutic benefit.

If approved, Bysanti would qualify for five years of regulatory data exclusivity in the U.S., while pending patent applications could extend protection into the 2040s. The FDA accepted the NDA in May 2025.

Bysanti would compete primarily with other atypical antipsychotics, including Abilify, Invega Sustenna, and Lybalvi, among others.

Vanda's regulatory victory comes after the FDA rejected its sedative Hetlioz for jet lag in early January. The agency at the time argued that Vanda had failed to sufficiently establish Hetlioz's efficacy for jet lag—an assessment the biotech disagreed with. Outside of Hetlioz, Vanda won the FDA's greenlight for Nereus in motion sickness late last year, marking the first approval for this indication in more than four decades.