Ingrezza (valbenazine) / Neurocrine, Mitsubishi Tanabe - LARVOL DELTA

Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Virginia Commonwealth University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Dystonia • Movement Disorders

Neurocrine Biosciences Presents Real-World Data on Therapeutic Dose Attainment and Dosing Trends of VMAT2 Inhibitors in Patients With Tardive Dyskinesia (PRNewswire) - "Neurocrine Biosciences, Inc...announced the presentation of new data from a real-world study showing that all patients with tardive dyskinesia achieved a therapeutic dose with INGREZZA (valbenazine) capsules upon initiation of treatment. This retrospective cohort study will be presented at the Academy of Managed Care Pharmacy 2025 Annual Meeting in Houston, Texas...All patients treated with INGREZZA at 40 mg, 60 mg or 80 mg reached a therapeutic dose upon initiation of treatment, while significantly fewer deutetrabenazine-treated patients were able to reach a therapeutic dose within six months; Only 47.5% of patients on deutetrabenazine BID and 54.3% of patients on deutetrabenazine XR were able to reach a therapeutic dose within six months, with an average attainment time of three to four weeks (P<0.001)....Fewer patients taking INGREZZA experienced a dose change when compared with those taking deutetrabenazine."

Real-world evidence • Movement Disorders

Impact of Valbenazine on Improvements in Disability and Functional Impairment in Patients With Tardive Dyskinesia (TD): Sheehan Disability Scale (SDS) Results From a Phase 4 Randomized Withdrawal Study (NCT03891862) (ISPOR 2025) - P4 | "A phase 4 study assessed persistence of effects of valbenazine, a VMAT2 inhibitor approved for TD and chorea associated with Huntington's disease, versus placebo. Patients received open-label (OL) valbenazine up to 80 mg for 8 weeks then were randomized to either continue valbenazine or receive placebo for 8 weeks. Patients receiving 8 weeks OL valbenazine had improvements in functioning and disability, evidenced by reduced SDS scores. Patients randomized to valbenazine experienced continued improvements in all SDS domains, including significant enhancements in social life and family/home life compared to those randomized to placebo."

Clinical • P4 data • Huntington's Disease • Movement Disorders

Assessing Real-World Dosing Patterns for Vesicular Monoamine Transporter-2 Inhibitors (VMAT2i), Valbenazine and Deutetrabenazine, Among Patients with Tardive Dyskinesia (TD) in a Nationwide US Claims Database (ISPOR 2025) - "Persistent patients taking valbenazine experienced fewer month-to-month dose changes than deutetrabenazine patients, potentially representing a simpler treatment regimen for patients and providers. Additionally, over one-quarter of persistent deutetrabenazine patients on either formulation did not attain therapeutic dosing."

Claims database • Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders

Impact Of Valbenazine On Improvements In Health-Related Quality of Life (HRQoL) In Patients With Tardive Dyskinesia (TD): EQ-5D-5L Results From A Phase 4 Randomized Withdrawal Study (NCT03891862) (ISPOR 2025) - P4 | "A phase 4 study assessed persistence of effects of valbenazine, a VMAT2 inhibitor approved for treatment of TD and chorea associated with Huntington's disease, versus placebo. Patients received open-label (OL) valbenazine up to 80 mg for 8 weeks, then were randomized to continue valbenazine or receive placebo for 8 weeks. Patients receiving 8 weeks of OL valbenazine had improvements in HRQoL via the EQ-5D-5L. Patients randomized to valbenazine experienced continued improvements in all EQ-5D-5L items including significant improvements in mobility and anxiety/depression compared to patients randomized to placebo."

Clinical • HEOR • P4 data • CNS Disorders • Depression • Huntington's Disease • Mood Disorders • Movement Disorders • Pain • Psychiatry

Indirect Treatment Comparison for Early Efficacy of VMAT2 Inhibitors for Tardive Dyskinesia and Chorea Associated with Huntington's Disease (ISPOR 2025) - "OBJECTIVES: Two vesicular monoamine transporter 2 (VMAT2) inhibitors, valbenazine and deutetrabenazine, are approved for both tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). Favorable improvements were found with valbenazine versus deutetrabenazine during early treatment for both TD and HD-chorea. Magnitude of effect and time needed to reach an effective dose are important considerations when choosing a medication to treat the hyperkinetic movement disorders of TD or HD-chorea."

Clinical • Huntington's Disease • Movement Disorders

Neurocrine Biosciences Presents 48-Week Remission Data on Treatment of Tardive Dyskinesia With INGREZZA (valbenazine) Capsules (PRNewswire) - P3 | N=167 | KINECT 4 (NCT02405091) | Sponsor: Neurocrine Biosciences | "Neurocrine Biosciences...today presented new data from the long-term, open-label KINECT 4 study demonstrating remission of tardive dyskinesia among the majority of patients treated with once-daily INGREZZA (valbenazine) capsules. The post-hoc analysis was conducted using data from 103 participants who reached the final Week 48 visit in the KINECT 4 clinical trial and assessed a proposed threshold for remission of tardive dyskinesia (TD) symptoms using the Abnormal Involuntary Movement Scale (AIMS). The threshold for remission was defined as an AIMS item score of ≤1 (rating of "none" or "minimal") in each of the seven body regions (items 1-7). The percentage who met the threshold for remission was analyzed by dose (40 mg and 80 mg) and by psychiatric diagnosis (schizophrenia or schizoaffective disorder, mood disorder)."

P3 data • Movement Disorders

Neurocrine Biosciences Presents New KINECT-HD Data Showing Significant Reduction in Chorea Across Body Regions With INGREZZA (valbenazine) Capsules (PRNewswire) - P3 | N=128 | KINECT-HD (NCT04102579) | Sponsor: Neurocrine Biosciences | "The post-hoc analysis was presented at the Neuroscience Advanced Practice Provider Symposium hosted by the American Association of Neuroscience Nurses in New Orleans...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....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."

P3 data • Huntington's Disease

Lurasidone-Induced Tardive Dyskinesia Reversed With Lithium Therapy: A Case Report. (PubMed, J Pharm Pract) - "It has wide-reaching effects on patients' well-being, quality of life,1 and treatment adherence.2 Thus, TD is debilitating, leading to social withdrawal,3 and workplace absenteeism.1 Current data on tardive dyskinesia treatment are limited, and prevention, primarily through the modification of antipsychotic regimens, remains the most effective strategy.4 Recent systematic review has shown valbenazine and vitamin E are the only treatments significantly more effective compared to placebo in treatment of TD, although valbenazine is associated with significant side effects.5 We present a case of a 76-year-old female with a diagnosis of Bipolar II Disorder (BD) who developed TD after treatment with lurasidone for 10 years...This article reviews the literature discussing the interplay between lithium and TD and presents a case report of TD improvement after lithium augmentation for treatment-resistant depression. While this case suggests a potential role in TD..."

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Psychiatry

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders (AAN 2025) - "Of 347 prescriptions for VMAT2 inhibitors, 94% were prescribed tetrabenazine, 4.6% deutetrabenazine and 1.4% valbenazine. Our study suggests that VMAT2 inhibitors are effective and safe for treating pediatric hyperkinetic movement disorders. While adverse effects were common, most were mild and improved with dosage reduction or transitioning to deutetrabenazine or valbenazine. Furthermore, this study provides insight into barriers to pediatric access."

Clinical • Real-world • Real-world evidence • Movement Disorders • Pediatrics

Effect Sizes of Once-daily Valbenazine for Tardive Dyskinesia: A Post-hoc Analysis of KINECT® 3 Data (AAN 2025) - P3 | "Effect sizes have been reported for common neuropsychiatric medications relative to placebo, including antidepressants for major depressive episodes (d=0.4), antipsychotics for schizophrenia (d=0.5), deutetrabenazine for TD (d=0.6), and levodopa for Parkinson's disease (d=0.9).Design/Cohen's d effect sizes for valbenazine in TD were calculated using Abnormal Involuntary Movement Scale (AIMS) data from KINECT® 3 (NCT02274558), a 6-week phase 3 study with valbenazine (40 or 80 mg) versus placebo. Based on AIMS data from KINECT 3, meaningful effect sizes were detected as early as Week 2 with a large effect size noted for valbenazine 80 mg by Week 6."

Retrospective data • CNS Disorders • Depression • Huntington's Disease • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Effect Sizes of Once-daily Valbenazine for Chorea Associated with Huntington's Disease: A Post-hoc Analysis of KINECT®-HD Data (AAN 2025) - P3 | "Effect sizes reported for common neurologic treatments include levodopa for Parkinson's disease (0.9), sumatriptan for migraines (0.8), methylphenidate for attention-deficit/hyperactivity disorder (0.8), and memantine for moderate-to-severe Alzheimer's disease (0.3 to 0.5).Design/Cohen's d effect sizes for valbenazine in HD chorea were calculated using Unified Huntington's Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) data from KINECT®-HD (NCT04102579), a 12-week phase 3 study of valbenazine (≤80 mg) versus placebo. Based on TMC data from KINECT-HD, meaningful effect sizes were detected as early as Week 2 at the initial 40-mg dose. Effect sizes for valbenazine generally increased throughout the 12-week trial to a large effect size at maintenance."

Retrospective data • ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Huntington's Disease • Migraine • Movement Disorders • Pain • Parkinson's Disease • Psychiatry

Improvement in Quality of Life and Functional Status Following Valbenazine Treatment in Patients with Tardive Dyskinesia: Real-world Data from a Chart Extraction and Clinician Survey (AAN 2025) - "Real-world, valbenazine-treated TD patients experienced improvement in functional, social, independence, emotional, and physical aspects of their lives, irrespective of TD severity. Data on independence, ADLs, and antipsychotic medication adherence added new information to prior analyses in functional and QoL improvements beyond movement symptoms."

Clinical • HEOR • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Sustained Chorea Improvements with Long-term, Once-daily Valbenazine in Adults with Huntington's Disease (AAN 2025) - P3 | "KINECT-HD2 results indicate acceptable long-term safety/tolerability of once-daily valbenazine, along with rapid, sustained, and clinically meaningful chorea improvement. Outcomes with valbenazine in adults with HD chorea were unaffected by concomitant use of antipsychotic therapy."

Clinical • CNS Disorders • Fatigue • Huntington's Disease • Mood Disorders • Movement Disorders • Psychiatry

Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Yale University | Trial primary completion date: Oct 2025 ➔ Oct 2026

Trial primary completion date

Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia (clinicaltrials.gov) - P4 | N=59 | Completed | Sponsor: Neurocrine Biosciences | Active, not recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Neurocrine Biosciences Reports Patient-Reported Outcome Data from KINECT-PRO Study for INGREZZA (valbenazine) Capsules in Tardive Dyskinesia: Significant and Clinically Meaningful Improvements in Functionality and Quality of Life Measures (PRNewswire) - P4 | N=59 | KINECT-PRO (NCT05859698) | Sponsor: Neurocrine Biosciences | "Neurocrine Biosciences...today announced top-line data from a Phase 4 study, KINECT-PRO...Fifty-nine patients were enrolled in the KINECT-PRO study and received once-daily INGREZZA (40 mg, 60 mg or 80 mg) for up to 24 weeks. Fifty-two patients completed the Week 24 visit....The primary objective of the KINECT-PRO study was to evaluate changes in patient-reported physical and socio-emotional impacts of TD, changes in a person's work, family, social life and overall sense of health and well-being during INGREZZA treatment. These outcomes were measured at Weeks 4, 8, 16 and 24 by the Tardive Dyskinesia Impact Scale (TDIS), the Sheehan Disability Scale (SDS) and the EQ Visual Analogue Scale (EQ-VAS), respectively."

P4 data • CNS Disorders

A narrative review of phase III and IV clinical trials for the pharmacological treatment of Huntington's disease in adults. (PubMed, Medicine (Baltimore)) - "The medications used in phase III and IV trials are minocycline, valbenazine, deutetrabenazine, tominersen, pridopidine (phase III), and memantine (phase IV)...Current medications aim to manage HD symptoms, potentially improving outcomes and reducing disease progression risks. The growing emphasis on specific approaches reflects a better understanding of HD's diverse symptoms, presenting opportunities for more effective and personalized treatment strategies."

Journal • P3 data • Review • CNS Disorders • Genetic Disorders • Huntington's Disease • Movement Disorders • Psychiatry

Safety and Efficacy of Deutetrabenazine at High versus Lower Daily Dosages in the ARC-HD Study to Treat Chorea in Huntington Disease. (PubMed, CNS Drugs) - P3 | "In this open-label, long-term study, some participants received deutetrabenazine dosing > 48 mg/d to achieve adequate chorea control. There was no new safety concern or incremental change in the safety profile between dosages of ≤ 48 mg/d and > 48 mg/d. These results include dosages that have not been approved for clinical use, however, they increase our understanding of safety and tolerability of deutetrabenazine doses."

Journal • CNS Disorders • Genetic Disorders • Huntington's Disease • Movement Disorders • Psychiatry

Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Virginia Commonwealth University

New P2 trial • CNS Disorders • Dystonia • Movement Disorders

Valbenazine for the treatment of chorea associated with Huntington's disease. (PubMed, Expert Opin Pharmacother) - "Even though multiple classes of medications have been used to treat this symptom, only the vesicular monoamine transporter 2 (VMAT2) inhibitors tetrabenazine, deutetrabenazine, and valbenazine have been approved by the FDA for this indication. The cost of this medication could be a barrier to access, even for those with insurance, due to high co-pay fees. Head-to-head clinical trials are needed to compare valbenazine's efficacy with the other approved drugs for chorea in HD."

Journal • Review • CNS Disorders • Huntington's Disease • Movement Disorders • Parkinson's Disease • Psychiatry

Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine As Adjunctive Treatment for Schizophrenia (clinicaltrials.gov) - P3 | N=442 | Active, not recruiting | Sponsor: Neurocrine Biosciences | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Efficacy and acceptability of pharmacological interventions for tardive dyskinesia in people with schizophrenia or mood disorders: a systematic review and network meta-analysis. (PubMed, Mol Psychiatry) - "In network 2 (k = 2, n = 63), switch to molindone (k = 1, n = 9) versus switch to haloperidol worsened TD (SMD = 1.68; 95% CI = 0.61,2.76)...Despite large effect sizes for some treatments with very low quality/confidence, when considering higher quality evidence only valbenazine or deutetrabenazine are evidence-based first-line treatments for TD, and potentially vitamin E as second-line. Switching to molindone and antipsychotic washout should be avoided. More treatment options and higher-quality trials are needed."

Journal • Retrospective data • Review • CNS Disorders • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Psychological Adjustment to Tardive Dyskinesia (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Yale University | Trial completion date: Jan 2025 ➔ Oct 2025 | Trial primary completion date: Jan 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Movement Disorders

Suicidal Ideation and Self-harming Thoughts With Valbenazine Use: A Case Report. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal • Psychiatry • Suicidal Ideation