The FDA has approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) tablets for the treatment of acute manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
Bysanti is the Washington-based biopharma’s second FDA approval in under two months, following the December 2025 approval of Nereus (tradipitant), a treatment for motion‑induced nausea and vomiting.
Bysanti’s approval represents the introduction of a new chemical entity (NCE) in the atypical antipsychotic class, a category of medications used to manage severe mental health disorders by targeting multiple neurotransmitter receptors in the brain.
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Bysanti is intended for adults experiencing acute manic or mixed episodes of bipolar I disorder, a condition marked by severe mood swings and functional impairment, as well as schizophrenia, a chronic psychiatric illness.
Mental health disorders such as bipolar I disorder and schizophrenia represent significant public health challenges, with millions of Americans affected and in need of better therapeutic options. Bysanti’s approval broadens the arsenal of antipsychotic medications available to clinicians, offering an additional oral option with a well‑characterized clinical profile.
In clinical studies, milsaperidone demonstrated bioequivalence with the company’s established antipsychotic Fanapt (iloperidone). Fanapt was first approved by the FDA in 2009 for schizophrenia, followed by a more recent approval in bipolar I disorder in April 2024.
The bioequivalence is established once Bysanti is absorbed in the body. This linkage enables Vanda to leverage the established efficacy and safety profile of Fanpat, the company explained in the release.
As a new chemical entity, Bysanti rapidly converts to iloperidone, producing dual active molecules that work together by antagonizing dopamine D2, serotonin 5-HT2A and alpha1-adrenergic receptors, thereby modulating key pathways involved in these psychiatric conditions. Its safety profile closely mirrors that of iloperidone, providing a well-characterized tolerability profile.
Vanda says that Bysanti’s distinctive receptor binding profile, characterized by strong alpha-adrenergic activity relative to dopamine and serotonin receptor binding, supports its potential for further study in disorders marked by hostility, agitation and hyperarousal.
“The Bysanti approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage,” Mihael Polymeropoulos, MD, CEO of Vanda, said in the company announcement. “Bysanti exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health.”
The FDA’s decision follows several years of regulatory review. Vanda initially filed its New Drug Application (NDA) and received acceptance for review, with the agency granting approval on February 20, 2026.
The drug is expected to be commercially available in the US by Q3 2026.
Regulatory data exclusivity and issued patents are projected to protect Bysanti from generic competition through at least 2044, a nearly two‑decade intellectual property runway that could support long‑term market presence.
Bysanti is currently being evaluated as a once-daily adjunctive therapy for treatment-resistant major depressive disorder in an ongoing clinical trial, with completion expected by the end of this year.
Vanda’s company shares surged sharply in extended trading following the announcement.
Earlier this month, Vanda reported 2025 sales of Fanapt at $117 million, up 24%, boosted by the new 2024 indication for acute bipolar I. Total 2025 revenue reached $216 million, a 9% increase year-over-year, with 2026 projections of $230 million to $260 million.
Shortly after Bysanti’s approval, the FDA accepted Vanda’s biologics license application (BLA) for imsidolimab to treat generalized pustular psoriasis (GPP), a rare and potentially life‑threatening inflammatory skin disease. The FDA has set a target action date of December 12, 2026, for it.
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