Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti鈩� 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鈩� (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鈩�, 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鈩� 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鈩� (milsaperidone), mirata al trattamento del disturbo bipolare I acuto e della schizofrenia. La richiesta 猫 supportata da diversi studi clinici che valutano l'efficacia e la sicurezza del farmaco.
Bysanti鈩�, 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 esclusivit脿 che si estende fino agli anni 2040.
Inoltre, Vanda ha avviato un trial clinico di Fase III per investigare Bysanti鈩� 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鈩� (milsaperidone), dirigida al tratamiento del trastorno bipolar I agudo y la esquizofrenia. La solicitud cuenta con el respaldo de m煤ltiples estudios cl铆nicos que eval煤an la eficacia y seguridad del f谩rmaco.
Bysanti鈩�, un nuevo antipsic贸tico at铆pico, act煤a interactuando con varios receptores de neurotransmisores, incluidos los receptores alfa-adren茅rgicos, de serotonina y de dopamina en el cerebro. Si se aprueba, el f谩rmaco podr铆a llegar al mercado estadounidense para 2026, con una posible exclusividad que se extender铆a hasta la d茅cada de 2040.
Adem谩s, Vanda ha lanzado un ensayo cl铆nico de Fase III que investiga Bysanti鈩� como tratamiento complementario diario para el trastorno depresivo mayor (MDD), con resultados anticipados para 2026.
氚橂嫟 鞝滌暯(VANDA Pharmaceuticals, NASDAQ: VNDA)电� Bysanti鈩� (氚�靷帢毽張)鞐� 雽�頃� 靸堧鞖� 鞚橃暯頀� 鞁犾箔(NDA)鞚� FDA鞐� 鞝滌稖頄堨姷雼堧嫟. 鞚� 鞎诫鞚� 旮夓劚 鞏戧饭靹� I 鞛レ暊 氚� 鞝曥嫚攵勳棿歃� 旃橂毳� 氇╉憸搿� 頃橁碃 鞛堨姷雼堧嫟. 鞚� 鞁犾箔靹湹鐢 鞎诫鞚� 須姤瓿� 鞎堨爠靹膘潉 韽夑皜頃樀鐢 鞐煬 鞛勳儊 鞐瓣惮鞐� 鞚橅暣 霋冯皼旃惄雼堧嫟.
Bysanti鈩⒌鐢 靸堧鞖� 牍勳爼順� 頃爼鞁犽硲鞝滊, 雵岇潣 鞎岉寣-鞎勲摐霠堧偁毽�, 靹鸽韱犽媽 氚� 霃勴寣氙� 靾橃毄觳挫檧 靸來樃鞛戩毄頃橃棳 鞛戩毄頃╇媹雼�. 鞀轨澑鞚� 霅滊嫟氅�, 鞚� 鞎诫鞚� 2026雲勱箤歆� 氙戈淡 鞁滌灔鞐� 霃勲嫭頃� 靾� 鞛堨溂氅�, 2040雲勲寑旯岇 鞛犾灛鞝侅澑 霃呾爯甓岇澊 鞐办灔霅� 靾� 鞛堨姷雼堧嫟.
霕愴暅, 氚橂嫟电� 欤检殧 鞖办毟 鞛レ暊(MDD)鞐� 雽�頃� 頃橂（ 頃� 氩� 氤挫“ 旃橂鞝滊 Bysanti鈩㈦ゼ 臁办偓頃樀鐢 3靸� 鞛勳儊 鞁滍棙鞚� 鞁滌瀾頄堨溂氅�, 瓴瓣臣电� 2026雲勳溂搿� 鞓堨儊霅╇媹雼�.
Vanda Pharmaceuticals (NASDAQ: VNDA) a soumis une Demande de Nouveau M茅dicament (NDA) 脿 la FDA pour Bysanti鈩� (milsaperidone), visant 脿 traiter le trouble bipolaire I aigu et la schizophr茅nie. La demande est soutenue par plusieurs 茅tudes cliniques 茅valuant l'efficacit茅 et la s茅curit茅 du m茅dicament.
Bysanti鈩�, un nouvel antipsychotique atypique, agit en interagissant avec divers r茅cepteurs de neurotransmetteurs, y compris les r茅cepteurs alpha-adr茅nergiques, de la s茅rotonine et de la dopamine dans le cerveau. S'il est approuv茅, le m茅dicament pourrait atteindre le march茅 am茅ricain d'ici 2026, avec une exclusivit茅 potentielle s'茅tendant jusqu'aux ann茅es 2040.
De plus, Vanda a lanc茅 un essai clinique de Phase III pour 茅tudier Bysanti鈩� comme traitement d'appoint quotidien pour le trouble d茅pressif majeur (MDD), avec des r茅sultats attendus en 2026.
Vanda Pharmaceuticals (NASDAQ: VNDA) hat einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) bei der FDA f眉r Bysanti鈩� (Milsaperidon) eingereicht, der auf die Behandlung von akutem bipolaren I-St枚rungen und Schizophrenie abzielt. Der Antrag wird durch mehrere klinische Studien unterst眉tzt, die die Wirksamkeit und Sicherheit des Medikaments bewerten.
Bysanti鈩�, ein neuartiges atypisches Antipsychotikum, wirkt, indem es mit verschiedenen Neurotransmitter-Rezeptoren im Gehirn interagiert, einschlie脽lich Alpha-Adrenozeptoren, Serotonin- und Dopaminrezeptoren. Wenn es genehmigt wird, k枚nnte das Medikament bis 2026 auf den US-Markt kommen, mit einer potenziellen Exklusivit盲t, die bis in die 2040er Jahre reicht.
Dar眉ber hinaus hat Vanda eine Phase-III-Studie gestartet, die Bysanti鈩� als einmal t盲gliche Zusatzbehandlung f眉r die Major Depression (MDD) untersucht, wobei Ergebnisse f眉r 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鈩� is a new chemical entity that belongs in the class of atypical antipsychotic drugs. Bysanti鈩� 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鈩� 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鈩� 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 听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鈩�'s mechanism of action, the potential commercial availability of Bysanti鈩�, the potential to extend patent exclusivity for Bysanti鈩� into the 2040s, and the anticipated timing of the availability of results from the Phase III clinical study of Bysanti鈩� 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鈩� achieves its therapeutic effect, Vanda's ability to complete the clinical development of and obtain regulatory approval for Bysanti鈩� for the treatments of acute bipolar I disorder and schizophrenia by 2026, Vanda's ability to satisfy the conditions necessary to extend Bysanti鈩�'s patent exclusivity into the 2040s and Vanda's ability to complete the Phase III clinical study of Bysanti鈩� 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.
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FAQ
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