Bysanti is based on iloperidone, an active metabolite of a compound that forms the core of Fanapt, another drug by Vanda Pharmaceuticals.
After suffering a rebuff for its jet lag drug in January, 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, according to its Friday news release. 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,” Vanda said on Friday, 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, for instance, show that levels of both drugs follow similar trajectories over time.
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, according to its approval announcement. Bysanti offers “patients and providers a reliable new treatment grounded in extensive clinical heritage,” CEO Mihael Polymeropoulos said in a statement.
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.
Vanda asserted at the time that the models it used for its study “are widely accepted in circadian rhythm research as valid and reliable surrogates for simulating the core circadian misalignment underlying eastward jet lag.”
Hetlioz is at the center of a long-running dispute between Vanda and the FDA. After the first rejection of the drug in 2019, the biotech appealed in mid-2022, requesting a hearing. After silence from the agency, Vanda sued in September of that year. A judge in March 2024 ordered the FDA to either grant the company a hearing or resolve the application. The agency landed on the latter—which Vanda again challenged in an appeal that it won in August 2025.
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.
