Neurocrine Biosciences Presents New KINECT®-HD Data Showing Significant Reduction in Chorea Across Body Regions With INGREZZA® (valbenazine) Capsules
Neurocrine Biosciences (NBIX) has presented new data from the KINECT®-HD study demonstrating significant improvements in chorea symptoms with INGREZZA® (valbenazine) capsules in Huntington's disease patients. The post-hoc analysis, presented at the 2025 American Association of Neuroscience Nurses Symposium, showed consistent benefits across body regions.
The Phase 3 clinical trial involved 125 patients randomized to receive either INGREZZA (n=64) at doses of 40mg, 60mg, or 80mg, or placebo (n=61) over 12 weeks. The study measured chorea severity using the UHDRS® Total Maximal Chorea score across seven body regions.
Key findings revealed:
- More participants showed meaningful chorea improvements with INGREZZA versus placebo across all affected body regions
- Statistically significant improvements were observed in upper and lower extremities (P<0.05)
- Greatest improvements were seen in arms and legs, which had the highest severity at baseline
Neurocrine Biosciences (NBIX) ha presentato nuovi dati dallo studio KINECT®-HD che dimostrano significativi miglioramenti nei sintomi di corea con le capsule di INGREZZA® (valbenazina) nei pazienti affetti da malattia di Huntington. L'analisi post-hoc, presentata al Simposio 2025 dell'Associazione Americana degli Infermieri di Neuroscienze, ha mostrato benefici costanti in diverse regioni del corpo.
Il trial clinico di Fase 3 ha coinvolto 125 pazienti randomizzati a ricevere INGREZZA (n=64) a dosi di 40mg, 60mg o 80mg, oppure un placebo (n=61) per un periodo di 12 settimane. Lo studio ha misurato la gravità della corea utilizzando il punteggio UHDRS® Total Maximal Chorea su sette regioni corporee.
I risultati principali hanno rivelato:
- Un numero maggiore di partecipanti ha mostrato miglioramenti significativi nella corea con INGREZZA rispetto al placebo in tutte le regioni corporee interessate
- Miglioramenti statisticamente significativi sono stati osservati negli arti superiori e inferiori (P<0.05)
- I miglioramenti più consistenti sono stati registrati in braccia e gambe, che presentavano la gravità più alta all'inizio
Neurocrine Biosciences (NBIX) ha presentado nuevos datos del estudio KINECT®-HD que demuestran mejoras significativas en los síntomas de corea con las cápsulas de INGREZZA® (valbenazina) en pacientes con enfermedad de Huntington. El análisis post-hoc, presentado en el Simposio 2025 de la Asociación Americana de Enfermeras de Neurociencia, mostró beneficios consistentes en varias regiones del cuerpo.
El ensayo clínico de Fase 3 involucró a 125 pacientes aleatorizados para recibir INGREZZA (n=64) en dosis de 40mg, 60mg o 80mg, o un placebo (n=61) durante 12 semanas. El estudio midió la gravedad de la corea utilizando la puntuación UHDRS® Total Maximal Chorea en siete regiones corporales.
Los hallazgos clave revelaron:
- Más participantes mostraron mejoras significativas en la corea con INGREZZA en comparación con el placebo en todas las regiones corporales afectadas
- Se observaron mejoras estadísticamente significativas en las extremidades superiores e inferiores (P<0.05)
- Las mayores mejoras se vieron en brazos y piernas, que tenían la mayor gravedad al inicio
Neurocrine Biosciences (NBIX)는 헌팅턴병 환자에서 INGREZZA® (발베나진) 캡슐을 사용하여 무도증 증상이 유의미하게 개선되었다는 KINECT®-HD 연구의 새로운 데이터를 발표했습니다. 2025년 미국 신경과 간호사 협회 심포지엄에서 발표된 후속 분석 결과, 신체 여러 부위에서 일관된 이점이 나타났습니다.
3상 임상 시험은 125명의 환자를 무작위로 배정하여 INGREZZA (n=64)를 40mg, 60mg 또는 80mg의 용량으로 또는 위약 (n=61)을 12주 동안 투여했습니다. 이 연구는 7개 신체 부위에서 UHDRS® 총 최대 무도증 점수를 사용하여 무도증의 심각성을 측정했습니다.
주요 발견 사항은 다음과 같습니다:
- INGREZZA를 사용한 참가자들이 모든 영향을 받은 신체 부위에서 위약에 비해 의미 있는 무도증 개선을 보였습니다
- 상지와 하지에서 통계적으로 유의미한 개선이 관찰되었습니다 (P<0.05)
- 가장 큰 개선은 기초선에서 가장 심각했던 팔과 다리에서 나타났습니다
Neurocrine Biosciences (NBIX) a présenté de nouvelles données de l'étude KINECT®-HD montrant des améliorations significatives des symptômes de chorée avec les capsules d'INGREZZA® (valbénazine) chez les patients atteints de la maladie de Huntington. L'analyse post-hoc, présentée au Symposium 2025 de l'Association Américaine des Infirmiers en Neurosciences, a montré des bénéfices constants dans plusieurs régions du corps.
Le essai clinique de Phase 3 a impliqué 125 patients randomisés pour recevoir soit INGREZZA (n=64) à des doses de 40mg, 60mg ou 80mg, soit un placebo (n=61) pendant 12 semaines. L'étude a mesuré la gravité de la chorée en utilisant le score UHDRS® Total Maximal Chorea sur sept régions corporelles.
Les principales conclusions ont révélé:
- Un plus grand nombre de participants a montré des améliorations significatives de la chorée avec INGREZZA par rapport au placebo dans toutes les régions corporelles affectées
- Des améliorations statistiquement significatives ont été observées dans les membres supérieurs et inférieurs (P<0.05)
- Les plus grandes améliorations ont été observées dans les bras et les jambes, qui présentaient la gravité la plus élevée au départ
Neurocrine Biosciences (NBIX) hat neue Daten aus der KINECT®-HD-Studie präsentiert, die signifikante Verbesserungen der Chorea-Symptome mit INGREZZA® (Valbenazin) Kapseln bei Patienten mit Huntington-Krankheit zeigen. Die post-hoc-Analyse, die auf dem Symposium der American Association of Neuroscience Nurses 2025 vorgestellt wurde, zeigte konsistente Vorteile in verschiedenen Körperregionen.
Die Phase-3-Studie umfasste 125 Patienten, die randomisiert entweder INGREZZA (n=64) in Dosen von 40mg, 60mg oder 80mg oder ein Placebo (n=61) über 12 Wochen erhielten. Die Studie maß die Schwere der Chorea mit dem UHDRS® Total Maximal Chorea Score über sieben Körperregionen.
Wichtige Ergebnisse zeigten:
- Mehr Teilnehmer zeigten signifikante Verbesserungen der Chorea mit INGREZZA im Vergleich zum Placebo in allen betroffenen Körperregionen
- Statistisch signifikante Verbesserungen wurden in den oberen und unteren Extremitäten beobachtet (P<0.05)
- Die größten Verbesserungen wurden in Armen und Beinen festgestellt, die zu Beginn die höchste Schwere aufwiesen
- Statistically significant efficacy demonstrated in Phase 3 trial
- Positive clinical data showing improvement across all body regions
- Strong results in most severely affected areas (arms and legs)
- None.
Insights
Neurocrine's post-hoc analysis of the KINECT-HD trial reinforces INGREZZA's efficacy profile in Huntington's disease chorea, a significant expansion beyond its established tardive dyskinesia indication. The data demonstrating statistically significant improvements in upper and lower extremities (P<0.05) is particularly meaningful as these were the most severely affected body regions at baseline.
This granular body-region data strengthens INGREZZA's clinical profile by showing not just overall efficacy but targeted relief in the areas most impacting patients' daily functioning. The consistency of response across multiple body regions suggests robust target engagement of VMAT2 inhibition in the Huntington's disease population.
The therapeutic landscape for Huntington's chorea remains , with only two FDA-approved treatments available. INGREZZA's once-daily dosing offers a competitive advantage over tetrabenazine-based options that require multiple daily doses and carry higher side effect burdens. This data solidifies INGREZZA's position as a differentiated therapy in a medication class where tolerability and convenience significantly impact adherence and outcomes.
While these findings don't represent a completely new indication approval, they strengthen the clinical evidence supporting INGREZZA's effectiveness in this additional market segment, potentially driving increased physician comfort with prescribing.
- Data Reinforce the Clinically Meaningful Impact of INGREZZA in Adults with Huntington's Disease Chorea
- Findings Presented at the 2025 American Association of Neuroscience Nurses Neuroscience Advanced Practice Provider Symposium
"This analysis reinforces the primary study findings, showing the consistent benefit of INGREZZA in reducing the involuntary movements of chorea that can affect any part of the body," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "Notably, the most significant improvements were seen in the arms and legs, which were the most severely affected at baseline. These results are meaningful because they show how INGREZZA alleviates chorea symptoms and therefore helps people with Huntington's disease in their everyday lives."
In the 12-week, Phase 3 KINECT-HD clinical trial, once-daily INGREZZA demonstrated a significant reduction in chorea severity, as measured by the Unified Huntington's Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score, which measures chorea in seven body regions (face, buccal-oral-lingual region, trunk, right and left upper extremities, right and left lower extremities). This post-hoc analysis was conducted to assess the effect of INGREZZA on chorea by individual body region.
In the KINECT-HD study, patients were randomized 1:1 to receive INGREZZA (n=64) at doses of 40 mg, 60 mg or 80 mg, or placebo (n=61). TMC scores at baseline were similar between treatment groups. Key findings from the post-hoc analysis include:
- More participants had potentially meaningful chorea improvements (a TMC score shift from ≥2 at screening/baseline to ≤1 at maintenance) with INGREZZA versus placebo for all affected body regions.
- Statistically significant chorea improvements were observed for the upper and lower extremities (P<0.05 for each) – body regions with the highest chorea severity seen at baseline.
- Average TMC body region scores improved at maintenance, with numerically greater improvements for all TMC items with INGREZZA versus placebo.
About Chorea Associated with Huntington's Disease
Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease.
About KINECT®-HD
KINECT®-HD was a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of valbenazine as a once-daily treatment to reduce chorea associated with Huntington's disease (HD) and evaluate the safety and tolerability of valbenazine in patients with HD. The study enrolled 128 adults 18 to 75 years of age who were diagnosed with motor-manifest HD and who had sufficient chorea symptoms to meet study protocol criteria.
KINECT-HD used the Unified Huntington's Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score as the primary efficacy endpoint. The secondary endpoints included Clinical Global Impression of Change (CGI-C) response status and Patient Global Impression of Change (PGI-C) response status for valbenazine treatment. Treatment with valbenazine resulted in a placebo-adjusted mean reduction in the TMC score of 3.2 units (P<0.0001), indicating a substantial improvement in chorea. Secondary endpoints of CGI-C response status and PGI-C response status were also statistically significant and supported the improvements in TMC score that were seen over the 12-week study period.
Treatment-emergent adverse events in this study were generally consistent with the known safety profile of valbenazine. The most common adverse reactions in patients with HD included somnolence and sedation, urticaria, rash and insomnia.
View the complete study results from the Phase 3 KINECT-HD study published in The Lancet Neurology online edition. For more information on the KINECT-HD study, please visit HuntingtonStudyGroup.org.
About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration.
INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements.
INGREZZA is proven across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA® SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.
Important Information
Approved Uses
INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:
- movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
Do not take INGREZZA or INGREZZA SPRINKLE if you:
- are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:
- Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.
- Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.
- Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.
Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days.
The most common side effect of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
About Neurocrine Biosciences, Inc.
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 LinkedIn, X and Facebook. (*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA 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 potential benefits to be derived from INGREZZA for the treatment of chorea associated with Huntington's disease (HD) and the value INGREZZA may bring to patients with chorea associated with HD. Factors that 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 and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA for the treatment of chorea associated with HD; whether INGREZZA receives adequate reimbursement from third-party payors; the degree and pace of market uptake of INGREZZA for the treatment of chorea associated with HD; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA for the treatment of chorea associated with HD; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA for the treatment of chorea associated with HD, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA for the treatment of chorea associated with HD or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA for the treatment of chorea associated with HD; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA for the treatment of chorea associated with HD 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; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
© 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US- 0049 03/2025
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FAQ
What were the key results of NBIX's KINECT-HD study for INGREZZA in Huntington's disease?
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What dosages of INGREZZA were tested in NBIX's KINECT-HD study?
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