Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia
Vanda Pharmaceuticals (NASDAQ: VNDA) has submitted a New Drug Application (NDA) to the FDA for Bysanti™ (milsaperidone), targeting the treatments of acute bipolar I disorder and schizophrenia. The application is backed by multiple clinical studies evaluating the drug's efficacy and safety.
Bysanti™, a novel atypical antipsychotic, works by interacting with various neurotransmitter receptors including alpha-adrenergic, serotonin, and dopamine receptors in the brain. If approved, the drug could reach the US market by 2026, with potential exclusivity extending into the 2040s.
Additionally, Vanda has launched a Phase III clinical trial investigating Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results anticipated in 2026.
Vanda Pharmaceuticals (NASDAQ: VNDA) ha presentato una Nuova Richiesta di Farmaco (NDA) alla FDA per Bysanti™ (milsaperidone), mirata al trattamento del disturbo bipolare I acuto e della schizofrenia. La richiesta è supportata da diversi studi clinici che valutano l'efficacia e la sicurezza del farmaco.
Bysanti™, un nuovo antipsicotico atipico, agisce interagendo con vari recettori dei neurotrasmettitori, tra cui i recettori alfa-adrenergici, della serotonina e della dopamina nel cervello. Se approvato, il farmaco potrebbe arrivare sul mercato statunitense entro il 2026, con una potenziale esclusività che si estende fino agli anni 2040.
Inoltre, Vanda ha avviato un trial clinico di Fase III per investigare Bysanti™ come trattamento aggiuntivo una volta al giorno per il disturbo depressivo maggiore (MDD), con risultati attesi nel 2026.
Vanda Pharmaceuticals (NASDAQ: VNDA) ha presentado una Nueva Solicitud de Medicamento (NDA) a la FDA para Bysanti™ (milsaperidone), dirigida al tratamiento del trastorno bipolar I agudo y la esquizofrenia. La solicitud cuenta con el respaldo de múltiples estudios clínicos que evalúan la eficacia y seguridad del fármaco.
Bysanti™, un nuevo antipsicótico atípico, actúa interactuando con varios receptores de neurotransmisores, incluidos los receptores alfa-adrenérgicos, de serotonina y de dopamina en el cerebro. Si se aprueba, el fármaco podría llegar al mercado estadounidense para 2026, con una posible exclusividad que se extendería hasta la década de 2040.
Además, Vanda ha lanzado un ensayo clínico de Fase III que investiga Bysanti™ como tratamiento complementario diario para el trastorno depresivo mayor (MDD), con resultados anticipados para 2026.
반다 제약(VANDA Pharmaceuticals, NASDAQ: VNDA)는 Bysanti™ (밀사페리돈)에 대한 새로운 의약품 신청(NDA)을 FDA에 제출했습니다. 이 약물은 급성 양극성 I 장애 및 정신분열증 치료를 목표로 하고 있습니다. 이 신청서는 약물의 효능과 안전성을 평가하는 여러 임상 연구에 의해 뒷받침됩니다.
Bysanti™는 새로운 비정형 항정신병제로, 뇌의 알파-아드레날린, 세로토닌 및 도파민 수용체와 상호작용하여 작용합니다. 승인이 된다면, 이 약물은 2026년까지 미국 시장에 도달할 수 있으며, 2040년대까지 잠재적인 독점권이 연장될 수 있습니다.
또한, 반다는 주요 우울 장애(MDD)에 대한 하루 한 번 보조 치료제로 Bysanti™를 조사하는 3상 임상 시험을 시작했으며, 결과는 2026년으로 예상됩니다.
Vanda Pharmaceuticals (NASDAQ: VNDA) a soumis une Demande de Nouveau Médicament (NDA) à la FDA pour Bysanti™ (milsaperidone), visant à traiter le trouble bipolaire I aigu et la schizophrénie. La demande est soutenue par plusieurs études cliniques évaluant l'efficacité et la sécurité du médicament.
Bysanti™, un nouvel antipsychotique atypique, agit en interagissant avec divers récepteurs de neurotransmetteurs, y compris les récepteurs alpha-adrénergiques, de la sérotonine et de la dopamine dans le cerveau. S'il est approuvé, le médicament pourrait atteindre le marché américain d'ici 2026, avec une exclusivité potentielle s'étendant jusqu'aux années 2040.
De plus, Vanda a lancé un essai clinique de Phase III pour étudier Bysanti™ comme traitement d'appoint quotidien pour le trouble dépressif majeur (MDD), avec des résultats attendus en 2026.
Vanda Pharmaceuticals (NASDAQ: VNDA) hat einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) bei der FDA für Bysanti™ (Milsaperidon) eingereicht, der auf die Behandlung von akutem bipolaren I-Störungen und Schizophrenie abzielt. Der Antrag wird durch mehrere klinische Studien unterstützt, die die Wirksamkeit und Sicherheit des Medikaments bewerten.
Bysanti™, ein neuartiges atypisches Antipsychotikum, wirkt, indem es mit verschiedenen Neurotransmitter-Rezeptoren im Gehirn interagiert, einschließlich Alpha-Adrenozeptoren, Serotonin- und Dopaminrezeptoren. Wenn es genehmigt wird, könnte das Medikament bis 2026 auf den US-Markt kommen, mit einer potenziellen Exklusivität, die bis in die 2040er Jahre reicht.
Darüber hinaus hat Vanda eine Phase-III-Studie gestartet, die Bysanti™ als einmal tägliche Zusatzbehandlung für die Major Depression (MDD) untersucht, wobei Ergebnisse für 2026 erwartet werden.
- NDA submission for two significant psychiatric indications
- Potential market entry by 2026
- Long patent protection period extending into 2040s
- Additional Phase III trial for MDD could expand market opportunity
- FDA approval not guaranteed
- Revenue generation still years away (2026)
- Phase III MDD trial results pending until 2026
Bysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. 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.
If approved, Bysanti™ could be available for sale in the US in 2026. Exclusivity, including pending patent applications, could extend into the 2040s. Additionally, Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026.
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 Bysanti™'s mechanism of action, the potential commercial availability of Bysanti™, the potential to extend patent exclusivity for Bysanti™ into the 2040s, and the anticipated timing of the availability of results from the Phase III clinical study of Bysanti™ for the treatment of MDD 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 assumptions regarding how Bysanti™ achieves its therapeutic effect, Vanda's ability to complete the clinical development of and obtain regulatory approval for Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia by 2026, Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s and Vanda's ability to complete the Phase III clinical study of Bysanti™ for the treatment of MDD and receive results in 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
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
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Collected Strategies
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SOURCE Vanda Pharmaceuticals Inc.
FAQ
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