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

Valbenazine Improves the Burden and Symptoms of Tardive Dyskinesia: Topline Results from the Phase 4 KINECT-PRO Study (MDS Congress 2025) - "This is the first study to report the effects of a VMAT2 inhibitor on the physical, social, and emotional impacts of TD using multiple PROs, including the validated and disease-specific TDIS. Results present a comprehensive assessment of the impact of TD on patients' lives and the broad range of improvements that occurred following VBZ treatment."

P4 data • CNS Disorders • Movement Disorders

Valbenazine Improves Chorea Across Multiple Body Regions in Adults With Huntington's Disease (MDS Congress 2025) - P3 | ".In this post-hoc analysis of TMC data from KINECT-HD, greater chorea improvements were found with valbenazine across all body regions, and more participants had clinical improvements in each region with valbenazine. These analyses support the primary study endpoint and demonstrate consistent valbenazine benefit across body regions."

Clinical • CNS Disorders • Movement Disorders

Physical, Mental, and Socioemotional Functional Improvement Following Valbenazine Treatment for TD: a Case Series (MDS Congress 2025) - "This case series adds granularity to the growing body of evidence that improvement extends beyond movement symptoms following appropriate TD treatment. Level of improvement by functional area after VBZ"

Clinical • CNS Disorders • Mental Retardation • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Scopolamine-induced Tardive Dyskinesia: A Case Report (MDS Congress 2025) - "He was then prescribed fluphenazine and deutetrabenazine for the diagnosis of tics and experienced drug-induced parkinsonism as a side effect with the onset of shuffling gait and right upper extremity rest tremor...He was started on valbenazine with significant improvement in his TD and minimal side effects of parkinsonism at the 60mg daily dosage. Although exacerbation of TD by anticholinergics is well documented in the literature, there are few cases of anticholinergic-associated TD documented. Further investigation is essential to determine the interplay between the cholinergic and dopaminergic systems, given the frequent use of anticholinergic medications for common disorders, including nausea, COPD, urinary frequency, and asthma."

Case report • Clinical • CNS Disorders • Epilepsy • Movement Disorders • Parkinson's Disease

Long-Term Safety and Efficacy of Valbenazine for Treating Huntington's Disease Chorea (MDS Congress 2025) - P3 | "KINECT-HD2 demonstrated long-term safety and tolerability of once-daily valbenazine. TEAEs were consistent with symptoms common to HD and/or adverse events reported in previous clinical trials of VMAT2 inhibitors for HD chorea. Chorea improvements were observed early with valbenazine and sustained through three years of treatment."

Clinical • CNS Disorders • Movement Disorders

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders (MDS Congress 2025) - "Our study suggests that VMAT2 inhibitors are effective 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 insights into barriers to access to these drugs by pediatric patients."

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

Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment (MDS Congress 2025) - P3 | "A majority of participants who received 48 weeks of once-daily valbenazine reached a potential threshold for remission of TD while on treatment, regardless of dose or psychiatric diagnosis. The threshold for remission used in this analysis could be applied to clinical settings and/or used in future research as a potential treatment goal for TD."

Clinical • CNS Disorders • Mental Retardation • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Decreased Disease Burden in Motor-Related HD-HI Domains Among Adults With Huntington's Disease Treated With Valbenazine (MDS Congress 2025) - P3 | "Based on patient self-reports, VBZ was associated with greater improvements in mobility, abnormal movements, and hand/arm function compared to PBO over the 12-week K-HD trial. These findings suggest that the effect of VBZ to reduce HD chorea may also decrease disease burden in motor-related domains."

Clinical • Ataxia • CNS Disorders • Movement Disorders

Huntington disease in a Patient with Extensive Psychiatric History (MDS Congress 2025) - "Patient received more social support and symptoms are managed by Valbenazine, clonidine, fluphenazine, duloxetine. The delayed diagnosis of Huntington's Disease in this young patient, due to confounding factors and initial psychiatric symptoms, underscores the importance of a comprehensive approach. This case serves to remind clinicians of the diverse clinical manifestations of HD and the need for early consideration in differential diagnoses. Figure 1: Brain MRI"

Clinical • ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Dementia • Depression • Mental Retardation • Movement Disorders • Post-traumatic Stress Disorder • Psychiatry • Suicidal Ideation

Hemichorea and Oromandibular Stereotypies Following Immunomodulatory Therapy in Multiple Myeloma: A Case Report (MDS Congress 2025) - "Stopping the chemotherapy and starting valbenazine eliminated the chorea and stereotypies within days. Hemichorea and oromandibular stereotypies resembling tardive dyskinesia may be a rare side effect of multiple myeloma treatment with lenalidomide, daratumumab, and bortezomib, occurring as early as two weeks after initiating treatment, through an as yet undescribed pathologic mechanism."

Case report • Clinical • Immunomodulating • CNS Disorders • Movement Disorders

Comparative Efficacy and Safety of VMAT2 Inhibitors for Chorea in Huntington's Disease: A Systematic Review and Meta-Analysis (MDS Congress 2025) - "Objective: To assess the safety and efficacy of vesicular monoamine transporter 2 (VMAT2) inhibitors (deutetrabenazine, tetrabenazine, valbenazine) in managing chorea in Huntington's Disease (HD). VMAT inhibitors effectively enhance chorea motor symptoms in HD, with notable CGI-C improvement. safety is considered acceptable, with fatigue being the most common side effect, but not significantly more prominent than placebo. Regardless of the restricted number of RCTs, this meta-analysis shows strong comparative evidence regarding VMAT2 inhibitors data available in the literature."

Retrospective data • Review • CNS Disorders • Movement Disorders

Amitriptyline-Induced Rabbit Syndrome: A Case of Refractory Oral Vertical Dyskinesia (MDS Congress 2025) - "She was started on valbenazine for her prior diagnosis of TD, but was discontinued as it worsened her symptoms...Trials of propranolol, carbidopa/levodopa, and benztropine showed minimal improvement... Rabbit syndrome is a rare, drug-induced oral vertical dyskinesia. Classically, it is characterized by rhythmic, peri-oral movements which resembles the chewing motion of a rabbit. Although it is typically associated with antipsychotics, it can also be triggered by other medications, including tricyclic antidepressants [1]."

Clinical • Preclinical • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Psychiatry

Factors Predicting the Efficacy of Valbenazine and Exacerbation of Tardive Dyskinesia After Valbenazine Discontinuation in Japanese Patients: A Post Hoc Analysis of the J-KINECT Study. (PubMed, J Clin Psychopharmacol) - "Although multiple regression analysis did not identify strong predictors of valbenazine efficacy and change in TD symptoms after valbenazine discontinuation, valbenazine dose was associated with meaningful improvement in TD. Rather than indicating efficacy in patients with specific factors, the data suggest a possible dose-dependent trend in improvement with valbenazine."

Journal • Retrospective data • CNS Disorders • Movement Disorders

Efficacy and safety of vesicular monoamine transporter 2 inhibitors for Huntington's disease chorea based on network meta-analysis. (PubMed, Front Pharmacol) - "Three VMAT2 inhibitors, including tetrabenazine, deutetrabenazine and valbenazine were investigated. Tetrabenazine is the most effective in controlling chorea, whereas valbenazine may be the optimal choice for patients with comorbid psychiatric symptoms. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251012431, identifier CRD420251012431."

Journal • Retrospective data • Review • Huntington's Disease • Movement Disorders • Psychiatry • Suicidal Ideation

Not the moves you asked for: exploring dopamine receptor-blocking agents-induced movement disorders (ECNP 2025) - "Treatment involves anticholinergic agents like benztropine or diphenhydramine to rapidly alleviate symptoms...Management includes dose reduction, switching to a lower-risk agent, beta-blockers (e.g., propranolol), and benzodiazepines...Management involves reducing or discontinuing the DRBA and switching to alternatives like clozapine or quetiapine, which have a lower risk of causing parkinsonism...Treatment focuses on the use of vesicular monoamine transporter 2 (VMAT2) inhibitors, such as valbenazine and deutetrabenazine... Beyond physical symptoms, DIMDs severely impact quality of life. Unlike psychiatric symptoms, which are internal, DIMDs are highly visible, leading to social stigma, emotional distress, and functional impairment. Akathisia has been linked to dysphoria and suicidal ideation, while TD can increase mortality."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dystonia • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Suicidal Ideation

Findings presented at 2025 MDS International Congress of Parkinson's Disease and Movement Disorders (PRNewswire) - "Robust improvements in the mean (±standard error of the mean [SEM]) UHDRS TMC score were observed by Week 2 (-3.4±0.3 [n=146]) at the lowest dose of INGREZZA (40 mg); Mean TMC improvements from baseline were observed at all post-baseline study visits (from Week 2 to Week 156); PGI-C response status at Week 2 with INGREZZA was 34.5% (50/145) followed by 75.9% at Week 104 and 77.8% at Week 156. Similar results were found for CGI-C....INGREZZA was generally well tolerated over the long term, and TEAEs observed in the study were consistent with its established safety profile and with known symptoms of Huntington's disease."

P3 data • Huntington's Disease

Efficacy and Safety of VMAT-2 Inhibitors and Dopamine Stabilizers for Huntington's Chorea: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis. (PubMed, Med Sci (Basel)) - "VMAT-2 inhibitors may suggest potential improvements in motor symptoms in Huntington's disease, while current evidence does not demonstrate a significant benefit of dopamine stabilizers. The safety profiles of both treatments appear generally comparable to placebo. Further rigorous and long-term studies are required to better establish their efficacy and safety."

Clinical • Journal • Retrospective data • Review • Genetic Disorders • Huntington's Disease • Movement Disorders

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Neurocrine Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Acute exacerbation of major depressive disorder following valbenazine treatment for tardive dyskinesia: A case report. (PubMed, PCN Rep) - "After she achieved partial psychiatric improvement on lurasidone, we started valbenazine to address her dyskinesia. This case shows that valbenazine can acutely worsen preexisting depression. Clinicians should actively evaluate psychiatric history, assess current mood stability before prescribing, and monitor patients closely to identify and address mood changes promptly."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry

New Developments in the Treatments of Psychosis (WFSBP 2025) - "Objective: Despite the discovery of chlorpromazine over 70 years ago and substantial pharmacologic advances, postsynaptic dopamine blockade has remained the sole mechanism of action of approved drugs for schizophrenia... Newly/recently approved agents include vesicular monoamine transporter-2 inhibitors valbenazine and deutetrabenazine for tardive dyskinesia and, possibly, residual positive symptoms; olanzapine/samidorphan combination, lumateperone, new formulations, including subcutaneous injections, and ultra-long-acting injectable antipsychotics. Agents in development that have at least one positive phase 1B, 2 or 3 trial include the trace amine-associated receptor-1 (TAAR1) ulotaront, M1/M4 muscarinic agonist xanomeline plus peripherally restricted anticholinergic trospium, the M4 muscarinic positive allosteric modulator emraclidine, as well as multiple other muscarinic receptor modulators for total psychopathology, methylated amisulpride (LB-102), and evenamide, a..."

CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy (clinicaltrials.gov) - P3 | N=86 | Active, not recruiting | Sponsor: Neurocrine Biosciences | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Cerebral Palsy • CNS Disorders • Movement Disorders

Efficacy of aripiprazole and valbenazine in the treatment of tourette syndrome: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Acta Neurol Belg) - "This meta-analysis indicates that aripiprazole is more effective than valbenazine in reducing tic severity and improving overall clinical outcomes in individuals with TS. While both agents demonstrated statistically significant benefits over placebo, aripiprazole yielded a greater magnitude of improvement with consistent results across studies. These findings support the continued use of aripiprazole as a first-line pharmacologic option, while highlighting valbenazine as a potential alternative in select cases. Further high-quality trials are warranted to clarify the role of valbenazine and optimize individualized treatment strategies for TS."

Journal • Retrospective data • Review • CNS Disorders • Developmental Disorders • Movement Disorders • Psychiatry • Tourette Syndrome

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P4 trial • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

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

Population Pharmacokinetic and Exposure-Efficacy Analyses of Valbenazine in Patients with Huntington's Disease: Supporting Dose Selection for Chorea Management. (PubMed, J Clin Pharmacol) - "Together, results from the population PK model and E-R analyses reinforce the evidence base for valbenazine efficacy in reducing chorea severity, as demonstrated by the notable decrease in TMC scores compared to baseline. They also endorse the selection of dosing regimens ranging from 40 to 80 mg QD for the treatment of chorea in patients with HD."

Journal • PK/PD data • Huntington's Disease • Movement Disorders