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

Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Yale University | N=15 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Movement Disorders

Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia (clinicaltrials.gov) - P3 | N=442 | Completed | Sponsor: Neurocrine Biosciences | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Feb 2025

Trial completion • Trial completion date • CNS Disorders • Psychiatry • Schizophrenia

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders. (PubMed, Tremor Other Hyperkinet Mov (N Y)) - "Of the 359 prescriptions for VMAT2 inhibitors, 94% included tetrabenazine, 4.6% deutetrabenazine, and 1.4% valbenazine. Our study suggests that VMAT2 inhibitors are effective for treating pediatric hyperkinetic movement disorders. Furthermore, this study provides insights into barriers to access to these drugs by pediatric patients."

Journal • Real-world evidence • Huntington's Disease • Movement Disorders • Pediatrics

Neurocrine Biosciences Presents New Post-Hoc Data Analyses from KINECT-HD Study Demonstrating Significant Reduction in Disease Burden with INGREZZA (valbenazine) Capsules for Huntington's Disease Chorea (PRNewswire) - P3 | N=128 | KINETIC-HD (NCT04102579) | Sponsor: Neurocrine Biosciences | "These analyses will be presented at the 2025 Advanced Therapeutics in Movement & Related Disorders Congress hosted by the Parkinson & Movement Disorder Alliance in Washington, D.C...In the 12-week Phase 3 KINECT-HD clinical trial, INGREZZA demonstrated a significant reduction in chorea severity, as measured by the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score. These post-hoc analyses were conducted to assess the effect of INGREZZA on motor and cognitive burden among people with Huntington's disease (HD) chorea using the Huntington's Disease Health Index (HD-HI), a disease-specific tool that was developed with patients and caregivers to assess disease burden across functional and psychological domains....At maintenance, INGREZZA demonstrated numerically larger reductions compared with placebo across all 18 cognition items and 32 of the 33 motor items."

P3 data • Huntington's Disease

Neurocrine Biosciences Presents New Data Showing Significant Patient-Reported Improvements in Health-Related Quality of Life with INGREZZA (valbenazine) Capsules in Older Adults with Tardive Dyskinesia (PRNewswire) - P4 | N=135 | NCT03891862 | Sponsor: Neurocrine Biosciences | "Findings will be presented at the 2025 American Association of Nurse Practitioners National Conference in San Diego...The analyses were conducted in a subset of 29 adult patients (≥65 years) who participated in a Phase 4, double-blind, placebo-controlled, randomized withdrawal study (NCT03891862)...Patients who received continued treatment with INGREZZA reported significant improvements in health-related quality of life and functional status, compared with those randomized to placebo...The EuroQol 5-Dimension 5-Level (EQ-5D-5L) assessment tool, which measures health-related quality of life across five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression); The Sheehan Disability Scale (SDS), which measures patient-reported functional impairment in work/school, social life and family/home life impairment."

P4 data • Patient reported outcomes • Movement Disorders

Electroconvulsive therapy for depression and oral dyskinesia in a patient who developed parkinsonism induced by valbenazine. (PubMed, PCN Rep) - "After the worsening of depression, the patient was hospitalized and underwent 10 sessions of modified ECT, which remarkably helped improving depressive symptoms and oral dyskinesia. This case suggests that ECT could be a viable treatment option for managing patients with depression and oral dyskinesia who are susceptible of valbenazine-induced parkinsonism."

Journal • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

Neurocrine Biosciences Presents Patient-Reported Outcomes from KINECT-PRO Study Demonstrating INGREZZA (valbenazine) Capsules Improved Functionality and Quality of Life in Patients with Tardive Dyskinesia (PRNewswire) - P4 | N=59 | NCT05859698 | Sponsor: Neurocrine Biosciences | "In the overall population, TDIS, SDS, EQ-VAS and AIMS improvements were observed as early as Week 4 after initial treatment with the lowest clinically effective INGREZZA dose (40 mg) and sustained through Week 24. Robust and sustained improvements in physical, social and emotional functioning were observed with INGREZZA, along with a substantial reduction in TD severity, regardless of TD severity at baseline or underlying psychiatric condition. Notably, even patients with milder TD movements were impacted by TD at baseline and saw improvements by Week 24...In the study, safety and tolerability of treatment were consistent with the known profile of INGREZZA, with no new concerns identified."

Patient reported outcomes • CNS Disorders

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 | Trial completion date: Mar 2025 ➔ Jul 2025

Trial completion date • CNS Disorders • Psychiatry • Schizophrenia

Early Improvement of Tardive Dyskinesia With Once-Daily Valbenazine: Effect Sizes and Numbers Needed to Treat (APA 2025) - P3 | "Effect sizes and NNTs based on AIMS data from the KINECT 3 study indicate that many patients may experience substantial TD improvements with valbenazine 80 mg once-daily by Week 2 of treatment. By Week 6, a medium treatment effect was observed with valbenazine 40 mg, and a large treatment effect was observed with valbenazine 80 mg."

Huntington's Disease • 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 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

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 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

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

New Ingrezza Data Demonstrates Functional and Quality of Life Improvements in Patients With Tardive Dyskinesia (Psychiatric Times) - P4 | N=135 | NCT03891862 | Sponsor: Neurocrine Biosciences | "Neurocrine Biosciences...announced new analyses from a phase 4 randomized withdrawal study (NCT03891862) showing participants with tardive dyskinesia who received continued treatment with valbenazine (Ingrezza) capsules demonstrated functional and health-related quality of life improvements...In the open-label portion of the study, participants receiving Ingrezza treatment for 8 weeks experienced significant improvements from baseline in multiple areas of HRQoL, including mobility (change from baseline: -0.27), self-care (-0.28), usual activities (-0.36), and pain/discomfort (-0.34). Those randomized to receive Ingrezza for an additional 8 weeks (week 16) saw continued improvements in all HRQoL dimensions, including significant improvements in mobility (placebo-adjusted difference from week 8: -0.34) and anxiety/depression (-0.38) compared with those receiving placebo."

HEOR • P4 data • CNS Disorders

Improvements Over Time with Valbenazine in Elderly Adults (≥65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies. (PubMed, J Clin Psychiatry) - P3 | " Valbenazine was safe and effective in elderly adults who received up to 48 weeks of treatment. Long-term treatment led to substantial and sustained TD improvements per clinician assessment (AIMS, CGI-TD) and patient report (PGIC), with no impact on psychiatric stability."

Clinical • Journal • Retrospective data • Infectious Disease • Movement Disorders • Nephrology • Psychiatry

Unique and overlapping mechanisms of valbenazine, deutetrabenazine, and vitamin E for tardive dyskinesia. (PubMed, Schizophrenia (Heidelb)) - "Pharmacological experiments should be conducted to verify and further explore these results. The findings offer a theoretical basis for further pharmacological investigation and a resource for TD drug screening."

Journal • Movement Disorders • DRD2 • NOS3 • SLC6A3 • TLR4

Neurocrine Biosciences Publishes Analysis Showing Long-Term Efficacy and a Consistent Safety Profile of INGREZZA (valbenazine) Capsules in Older Adults with Tardive Dyskinesia in The Journal of Clinical Psychiatry (PRNewswire) - "Neurocrine Biosciences...announced publication of a post-hoc analysis from two 48-week studies, the KINECT 3 extension and KINECT 4, demonstrating the long-term safety profile and robust efficacy of INGREZZA (valbenazine) capsules in adults aged 65 years and older with tardive dyskinesia (TD) in The Journal of Clinical Psychiatry....The pooled post-hoc analysis included 304 participants across studies who received a once-daily dose of INGREZZA (40 mg or 80 mg) for up to 48 weeks....Overall, psychiatric stability was maintained through 48 weeks of treatment and INGREZZA was generally well tolerated. The most common treatment-emergent adverse events reported from Weeks 8 to 48 included urinary tract infection and somnolence; each occurred in six of the 55 participants who were 65 years and older. There were no statistically significant differences between age groups (<65 versus ≥65) for most efficacy and safety outcomes at Week 48."

Retrospective data • CNS Disorders • Movement Disorders

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

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