Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026

Rhea-AI Summary

Vanda Pharmaceuticals announced that the FDA has accepted their New Drug Application (NDA) for Bysanti™ (milsaperidone), with a target decision date of February 21, 2026. Bysanti is a new chemical entity discovered to be bioequivalent to iloperidone, targeting bipolar I manic and mixed episodes and schizophrenia. The drug's efficacy is supported by multiple clinical studies, including two for acute schizophrenia episodes, one for bipolar I disorder, and one for schizophrenia relapse prevention. Safety data includes thousands of patient studies and over 80,000 patient-year exposures. Bysanti is also being studied as a once-daily treatment for major depressive disorder, with results expected in 2026. If approved, the drug will receive 5-year regulatory data exclusivity, with patent applications potentially extending protection into the 2040s.

Positive

• FDA accepted NDA filing with no potential review issues identified
• Drug shows bioequivalence to iloperidone in both low and high doses
• Extensive safety data from thousands of patients and 80,000+ patient year exposures
• Potential for extended patent protection into 2040s
• Possibility for future long-acting injectable formulations
• Additional market opportunity in major depressive disorder (MDD) treatment

Negative

• Long wait for FDA decision (February 2026)
• MDD study results won't be available until 2026
• Relies heavily on existing iloperidone data rather than new clinical trials

Insights

Pharmaceutical Regulatory Expert

FDA has filed Vanda's Bysanti NDA with decision by Feb 2026; bioequivalence to iloperidone enables streamlined approval pathway for psychiatric indications.

The FDA's acceptance of Vanda's New Drug Application (NDA) for Bysanti™ (milsaperidone) marks a significant regulatory milestone with a clear decision timeline. The FDA has set February 21, 2026 as the target date for decision, and notably, has identified no potential review issues at this stage.

The bioequivalence between milsaperidone and iloperidone represents a clever regulatory strategy. This equivalence allows Vanda to leverage existing clinical data from iloperidone studies rather than conducting entirely new efficacy trials – a pathway that typically saves years of development time and hundreds of millions in research costs. The safety database is particularly robust, with clinical studies involving thousands of patients plus post-marketing data covering more than 80,000 patient-year exposures.

The regulatory exclusivity position appears strong, with potential for 5-year regulatory data exclusivity upon approval plus patent applications that could extend protection into the 2040s. This intellectual property landscape would provide substantial market protection if Bysanti receives approval.

The company's development approach is methodical, targeting established indications of bipolar I manic/mixed episodes and schizophrenia initially, while simultaneously exploring additional applications like adjunctive treatment for major depressive disorder. The unique physical properties that make milsaperidone suitable for long-acting injectable formulations could differentiate this product in a market where medication adherence remains challenging.

Clinical Psychiatry Specialist

Bysanti offers potential new treatment option for serious psychiatric conditions with strong safety data and possible long-acting formulation benefits.

Vanda's Bysanti™ (milsaperidone) represents an interesting development in the treatment landscape for serious psychiatric conditions. As an atypical antipsychotic, it demonstrates strong affinity to alpha 1 adrenergic receptors, along with serotonin and dopamine receptors – a pharmacological profile believed to underlie its therapeutic effects.

The drug's demonstrated bioequivalence to iloperidone is clinically significant. This means the two compounds produce essentially identical blood levels and clinical effects, allowing Bysanti to leverage iloperidone's established efficacy record in schizophrenia and bipolar I disorder. The supporting clinical evidence includes two studies in acute schizophrenia, one in bipolar disorder, and one relapse prevention study in schizophrenia.

What's particularly valuable from a clinical perspective is the potential for developing long-acting injectable formulations due to milsaperidone's unique properties. In psychiatric practice, medication adherence remains one of the greatest treatment challenges. Long-acting injectables typically improve compliance, reduce hospitalization rates, and provide more consistent symptom control for patients struggling with regular oral medication adherence.

The ongoing development for adjunctive treatment of major depressive disorder could address an important unmet need. Many patients with MDD show inadequate response to first-line treatments, and augmentation strategies are often necessary. Results from this development program, expected in 2026, will determine whether Bysanti can expand beyond its initial indications to serve this substantial patient population.

WASHINGTON, May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application.

Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda has discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies.

The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona.

The efficacy and safety of Bysanti™ for the indications of bipolar I manic and mixed episodes and schizophrenia are supported by the clinical studies described on the iloperidone prescribing information. These include two studies in acute episodes of schizophrenia, one study in bipolar I disorder with manic or mixed episodes, and one relapse prevention study in schizophrenia. The safety of Bysanti™ is further supported by data in several thousand patients exposed to iloperidone in clinical studies, as well as the post marketing iloperidone experience, with more than 80,000 patient year exposures.  The unique physical and chemical properties of milsaperidone make it amenable to the development of lipid esters that could allow the future development of long acting injectable formulations.

Bysanti™ is currently under development in a clinical study as a once-a-day adjunctive treatment of major depressive disorder (MDD) for patients with inadequate response on their current treatment. Results are expected in 2026.

Bysanti™ is eligible for 5 year regulatory data exclusivity if approved by the FDA. Current Bysanti™ related patent applications, if issued, would extend into the 2040's.

Bysanti™ belongs to the class of atypical antipsychotics showing strong affinity to the alpha 1 adrenergic receptor, in addition to certain serotonin and dopamine receptors that are believed to explain its therapeutic effects.

"The extraordinary discovery of bioequivalence to iloperidone, of this novel chemical entity, allows for the efficient development of Bysanti™ and opens new opportunities to further explore additional therapeutic applications of this molecule," said Dr. Mihael Polymeropoulos, Vanda's President, CEO and Chairman of the Board.

About Bysanti™

Bysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. If approved, Bysanti™ could be available for sale in the US in 2026. Bysanti™ is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors. Exclusivity, including pending patent applications, could extend into the 2040s.

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this press release, including, but not limited to, statements regarding the potential to develop long acting injectable formulations of Bysanti™, the expected timing of the clinical study results for Bysanti™ in MDD, Bysanti™'s mechanism of action, the potential commercial availability of Bysanti™, the potential to extend patent exclusivity for Bysanti™ into the 2040s, the potential to develop additional therapeutic applications for Bysanti™, and the anticipated timing of the completion of the FDA's review of the Bysanti™ NDA are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to complete its clinical study in MDD and report results in 2026, Vanda's assumptions regarding how Bysanti™ achieves its therapeutic effect, Vanda's ability to obtain regulatory approval for Bysanti™ for the acute treatment of bipolar I disorder and schizophrenia and initiate its commercial launch in 2026, Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s, Vanda's ability to identify additional indications for Bysanti™ and the FDA's ability to complete its review of, and reach a decision with respect to, the Bysanti™ NDA by February 21, 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:

Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Jim Golden/Jack Keleher/Dan Moore
Collected Strategies
VANDA-CS@colectedstrategies.com

 

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

When will the FDA make a decision on Vanda's Bysanti (VNDA) NDA application?

The FDA has set February 21, 2026 as the target date for decision on Vanda's Bysanti NDA application.

What conditions will Bysanti (VNDA) treat?

Bysanti is being developed for bipolar I manic and mixed episodes, schizophrenia, and is under study as an adjunctive treatment for major depressive disorder (MDD).

How long will Vanda's (VNDA) patent protection for Bysanti last?

If approved, Bysanti will receive 5-year regulatory data exclusivity, with current patent applications potentially extending protection into the 2040s.

What is the safety profile of Vanda's Bysanti (VNDA)?

Bysanti's safety is supported by data from thousands of patients in clinical studies and over 80,000 patient year exposures through iloperidone post-marketing experience.

What makes Vanda's Bysanti (VNDA) unique?

Bysanti is a new chemical entity that is bioequivalent to iloperidone and has unique physical and chemical properties that could enable development of long-acting injectable formulations.