Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults
Neurocrine Biosciences (NBIX) has initiated a Phase 1 clinical study of NBI-1140675, their new second-generation VMAT2 inhibitor, in healthy adults. The study will evaluate the compound's safety, tolerability, pharmacokinetics and pharmacodynamics.
NBI-1140675 is an oral, selective small molecule inhibitor designed for treating neurological and neuropsychiatric conditions. It joins NBI-1065890 as the company's second VMAT2 inhibitor in Phase 1 trials.
This development builds on Neurocrine's track record with valbenazine, their first VMAT2 inhibitor, which received FDA approval for tardive dyskinesia treatment in 2017 and for Huntington's disease chorea in 2023. Valbenazine is currently in Phase 3 trials for schizophrenia and dyskinetic cerebral palsy.
Neurocrine Biosciences (NBIX) ha avviato uno studio clinico di Fase 1 per NBI-1140675, il loro nuovo inibitore di VMAT2 di seconda generazione, su adulti sani. Lo studio valuterà la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica del composto.
NBI-1140675 è un inibitore selettivo a piccole molecole da assumere per via orale, progettato per il trattamento di condizioni neurologiche e neuropsichiatriche. Si unisce a NBI-1065890 come secondo inibitore di VMAT2 dell'azienda in fase di sperimentazione clinica di Fase 1.
Questo sviluppo si basa sul percorso di Neurocrine con il valbenazina, il loro primo inibitore di VMAT2, che ha ricevuto l'approvazione della FDA per il trattamento della discinesia tardiva nel 2017 e per la corea di Huntington nel 2023. Il valbenazina è attualmente in fase di sperimentazione di Fase 3 per la schizofrenia e la paralisi cerebrale diskinetica.
Neurocrine Biosciences (NBIX) ha iniciado un estudio clínico de Fase 1 de NBI-1140675, su nuevo inhibidor de VMAT2 de segunda generación, en adultos sanos. El estudio evaluará la seguridad, tolerabilidad, farmacocinética y farmacodinámica del compuesto.
NBI-1140675 es un inhibidor selectivo de pequeñas moléculas que se administra por vía oral, diseñado para tratar condiciones neurológicas y neuropsiquiátricas. Se une a NBI-1065890 como el segundo inhibidor de VMAT2 de la empresa en ensayos de Fase 1.
Este desarrollo se basa en el historial de Neurocrine con valbenazina, su primer inhibidor de VMAT2, que recibió la aprobación de la FDA para el tratamiento de la discinesia tardía en 2017 y para la corea de Huntington en 2023. La valbenazina se encuentra actualmente en ensayos de Fase 3 para la esquizofrenia y la parálisis cerebral disquinética.
Neurocrine Biosciences (NBIX)는 건강한 성인을 대상으로 NBI-1140675의 1상 임상 시험을 시작했습니다. 이 연구는 화합물의 안전성, 내약성, 약동학 및 약력학을 평가할 것입니다.
NBI-1140675는 신경 및 신경정신적 질환 치료를 위해 설계된 경구용 선택적 소분자 억제제입니다. 이는 NBI-1065890과 함께 회사의 두 번째 VMAT2 억제제로 1상 임상 시험에 들어갑니다.
이 개발은 2017년 지연성 운동장애 치료를 위해 FDA 승인을 받은 Neurocrine의 첫 번째 VMAT2 억제제인 발베나진의 기록을 기반으로 합니다. 발베나진은 현재 정신분열증 및 운동장애성 뇌성마비에 대해 3상 임상 시험 중입니다.
Neurocrine Biosciences (NBIX) a lancé une étude clinique de Phase 1 sur NBI-1140675, leur nouvel inhibiteur de VMAT2 de deuxième génération, chez des adultes en bonne santé. L'étude évaluera la sécurité, la tolérance, la pharmacocinétique et la pharmacodynamique du composé.
NBI-1140675 est un inhibiteur sélectif de petites molécules administré par voie orale, conçu pour traiter des conditions neurologiques et neuropsychiatriques. Il rejoint NBI-1065890 en tant que deuxième inhibiteur de VMAT2 de l'entreprise en essais de Phase 1.
Ce développement s'appuie sur le parcours de Neurocrine avec le valbénazine, leur premier inhibiteur de VMAT2, qui a reçu l'approbation de la FDA pour le traitement de la dyskinésie tardive en 2017 et pour la chorée de Huntington en 2023. Le valbénazine est actuellement en essais de Phase 3 pour la schizophrénie et la paralysie cérébrale dyskinétique.
Neurocrine Biosciences (NBIX) hat eine klinische Studie der Phase 1 zu NBI-1140675, ihrem neuen VMAT2-Inhibitor der zweiten Generation, bei gesunden Erwachsenen gestartet. Die Studie wird die Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik der Verbindung bewerten.
NBI-1140675 ist ein oraler, selektiver kleiner Molekülinhibitor, der zur Behandlung neurologischer und neuropsychiatrischer Erkrankungen entwickelt wurde. Er ergänzt NBI-1065890 als den zweiten VMAT2-Inhibitor des Unternehmens in Phase-1-Studien.
Diese Entwicklung baut auf Neurocrines Erfolgen mit Valbenazin auf, ihrem ersten VMAT2-Inhibitor, der 2017 von der FDA zur Behandlung der tardiven Dyskinesie und 2023 zur Behandlung der Chorea Huntington genehmigt wurde. Valbenazin befindet sich derzeit in Phase-3-Studien für Schizophrenie und dyskinetische Zerebralparese.
- Initiated Phase 1 trial for new VMAT2 inhibitor NBI-1140675
- Second VMAT2 inhibitor in Phase 1 trials shows pipeline expansion
- Successful track record with first VMAT2 inhibitor (2 FDA approvals)
- Two additional Phase 3 trials ongoing for valbenazine
- Early-stage development (Phase 1) indicates long path to potential approval
- No efficacy data available yet for new compound
"We are focused on extending our bench of VMAT2 inhibitors in development, building on our successful discovery and development of valbenazine for the treatment of tardive dyskinesia and chorea in Huntington's disease," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "NBI-1140675 is an internally discovered, highly potent, selective VMAT2 inhibitor with the potential to provide differentiated benefit in treating certain neurological and neuropsychiatric conditions."
NBI-1140675 joins NBI-1065890 as a second-generation VMAT2 inhibitor undergoing evaluation by Neurocrine in Phase 1 clinical studies. VMAT2 inhibitors have been clinically validated as effective treatments for hyperkinetic movement disorders, playing an important role in presynaptic dopamine storage and release. Neurocrine successfully developed and received
About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, and Facebook.
(*in collaboration with AbbVie)
NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the efficacy and therapeutic potential of NBI-1140675. Factors could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with
© 2025 Neurocrine Biosciences. Inc. All Rights Reserved. CAP-NBI-US-0134 03/2025
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SOURCE Neurocrine Biosciences, Inc.
FAQ
What is the purpose of NBIX's Phase 1 trial for NBI-1140675?
How many VMAT2 inhibitors does NBIX now have in Phase 1 clinical trials?
What FDA approvals has NBIX received for their first VMAT2 inhibitor valbenazine?
What additional indications is NBIX pursuing for valbenazine in Phase 3 trials?
