SAN DIEGO, June 8, 2026
Neurocrine Biosciences announced new clinical findings demonstrating the long-term effectiveness of INGREZZA® (valbenazine) capsules for the treatment of tardive dyskinesia (TD), reinforcing the therapy’s ability to deliver meaningful symptom improvement across a broad range of patients. New analyses from the Phase 3 KINECT® 4 study showed that 94% of patients achieved either symptomatic remission or a clinically meaningful response after 48 weeks of treatment. Additional research presented at the 2026 Psych Congress Elevate highlighted the high prevalence of hepatic risk factors among patients with TD, underscoring the importance of treatment options that can be used in individuals with liver impairment.
KINECT 4 Analysis Demonstrates High Rates of Meaningful Clinical Response
The latest post-hoc analysis builds upon previously reported results from the 48-week KINECT 4 trial, where 59% of participants achieved symptomatic remission, defined as absent or minimal involuntary movements across all seven body regions measured by the Abnormal Involuntary Movement Scale (AIMS). Researchers found that among patients who did not reach this stringent remission threshold, the majority still experienced substantial symptom improvement. Specifically, 86% achieved at least a 30% reduction in total AIMS score, while 67% achieved a reduction of 50% or greater. When combined with patients who reached full remission, approximately 94% of treated participants experienced either remission or clinically meaningful improvement, highlighting the broad therapeutic impact of INGREZZA in reducing involuntary movements associated with tardive dyskinesia.
Long-Term Treatment Supports Durable Symptom Control
The Phase 3 KINECT 4 study enrolled adults with moderate to severe TD who also had underlying psychiatric conditions such as schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. Participants received once-daily INGREZZA 40 mg or 80 mg for 48 weeks. Results demonstrated substantial reductions in movement severity, with mean improvements in AIMS total scores of 10.2 points for the 40 mg dose and 11.0 points for the 80 mg dose. The treatment was generally well tolerated throughout the study, with urinary tract infection and headache representing the most commonly reported adverse events. Researchers also observed minimal changes in psychiatric stability, cardiovascular measures, and laboratory parameters, supporting the long-term safety profile of the therapy in a complex patient population.
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Hepatic Risk Analysis Highlights Importance of Individualized Treatment
A separate retrospective Medicare claims analysis involving more than 176,000 newly diagnosed TD patients revealed that 90% had at least one hepatic risk factor, while 44% had three or more risk factors associated with liver disease or hepatic impairment. Common risk factors included obesity, type 2 diabetes, hypertension, hyperlipidemia, and substance use disorders. Because liver disease may progress without obvious symptoms, these findings emphasize the importance of evaluating hepatic health when selecting treatment strategies for TD. Neurocrine noted that INGREZZA remains the only VMAT2 inhibitor with approved dosing recommendations for patients with hepatic impairment, providing clinicians with an important treatment option for a large portion of the TD population.
Expanding Evidence for INGREZZA in Movement Disorders
Tardive dyskinesia affects an estimated 800,000 adults in the United States and is characterized by persistent, involuntary movements that can significantly impact daily functioning and quality of life. The condition is commonly associated with long-term use of antipsychotic medications prescribed for psychiatric disorders. INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, works by regulating dopamine release in brain regions responsible for movement control. The new findings add to a growing body of evidence supporting INGREZZA’s ability to provide durable symptom relief and meaningful clinical outcomes across diverse patient populations. As the only VMAT2 inhibitor to demonstrate symptomatic remission in clinical trials, the therapy continues to strengthen its position as a leading treatment option for adults living with tardive dyskinesia.
Source: Neurocrine Biosciences, press release
