Phase 4 Study Highlights Valbenazine's Positive Impact on Patient-Reported Quality of Life, Daily Functioning in Tardive Dyskinesia

Patients with tardive dyskinesia (TD) treated with valbenazine (Ingrezza; Neurocrine Biosciences) showed significant improvements in patient-reported quality of life, daily functioning, and clinician-rated movement severity over 24 weeks, according to results from the phase 4, open-label KINECT-PRO study (NCT05859698) recently published in CNS Spectrums.^1,2

“Quality of life and day-to-day functioning are important considerations when evaluating the impact of tardive dyskinesia and treatment goals,” lead author Christoph U. Correll, MD, professor of psychiatry at the Zucker Hillside Hospital, Northwell Health, said in a statement.¹ “These findings showed improvements with INGREZZA in both clinician-rated movement severity and patient-reported daily impact and reinforced the potential for meaningful benefit across a broad range of patients regardless of baseline movement severity or underlying psychiatric diagnosis.”¹

KINECT-PRO enrolled 59 adults with TD and at least mild TD-related distress, and an underlying diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. At baseline, approximately 41% (24 of 59) had clinician-rated mild TD movement severity, while 59% (35 of 59) had moderate or severe TD. Participants received once-daily valbenazine, starting at 40 mg for 4 weeks and then flexibly dosed at 40, 60, or 80 mg through week 24; 52 of 59 (88%) completed the week 24 visit.

Primary end points measured change from baseline to week 24 on 3 validated patient-reported outcomes, including the Tardive Dyskinesia Impact Scale (TDIS), the EuroQoL Visual Analogue Scale (EQ-VAS), and the Sheehan Disability Scale (SDS). Secondary end points assessed movement severity via the Abnormal Involuntary Movement Scale (AIMS) and global impression measures.

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In the efficacy population (n = 45), mean TDIS scores improved 8.0 points, exceeding the scale's minimal clinically important difference (MCID) of 4 points, while AIMS total scores improved 6.8 points, surpassing its MCID of 2 points. EQ-VAS scores rose 13.1 points, and SDS social- and family-life scores decreased 2.3 and 1.6 points, respectively. TDIS and AIMS improvements exceeded MCID thresholds as early as week 8 and week 4, respectively, and persisted through week 24.

In total, about 58% of patients (26 of 45) met criteria for TD symptomatic remission at week 24, defined as an AIMS severity score of 0 or 1 across all 7 assessed body regions. Even patients with milder baseline TD had clinically meaningful mean changes of -6.8 points on TDIS and -5.6 points on AIMS. Investigators reported no new safety signals; adverse events (AEs) were consistent with valbenazine's known profile, which most commonly includes somnolence and sedation.

TD is a movement disorder marked by involuntary, repetitive movements of the face, trunk, and limbs that typically emerges after prolonged exposure to antipsychotics and other dopamine receptor-blocking medications, including metoclopramide and prochlorperazine. The condition is estimated to affect at least 800,000 adults in the US and can be persistent and irreversible.¹ AIMS-based severity ratings have long anchored TD trials but capture little about the disorder's effect on daily life, a gap TD-specific patient-reported measures have only recently begun to address.³

Valbenazine selectively inhibits the vesicular monoamine transporter 2 (VMAT2), reducing dopamine release without appreciable affinity for VMAT1 or dopaminergic, serotonergic, adrenergic, histaminergic, or muscarinic receptors. The FDA approved valbenazine for TD in adults in April 2017 based on the 6-week, randomized, double-blind, placebo-controlled KINECT 3 trial, in which the 80-mg/day dose produced a significantly greater reduction in AIMS dyskinesia score than placebo.⁴ The TDIS used in KINECT-PRO was developed from qualitative research and KINECT 3/KINECT 4 trial data and underwent psychometric validation published in 2024.³

“The KINECT-PRO clinical study incorporated validated patient-reported measures, including the Tardive Dyskinesia Impact Scale, to better understand the effects of treating tardive dyskinesia with INGREZZA on patient-reported quality of life and functioning,” Sanjay Keswani, MD, chief medical officer at Neurocrine Biosciences, said in a statement.¹ “These findings add to the extensive body of evidence supporting the meaningful improvements INGREZZA has on movement severity and quality of life and functionality.”

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REFERENCES
1. Neurocrine Biosciences announces publication of KINECT-PRO findings demonstrating INGREZZA (valbenazine) capsules improved patient-reported quality of life and daily functioning for people living with tardive dyskinesia. News release. Neurocrine Biosciences. August 12, 2026. Accessed September 2, 2026. https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-publication-kinect-protm
2. Correll CU, Perez-Rodriguez MM, McEvoy JP, et al. Valbenazine Improves Quality of Life, Functionality, and Movement Severity in Patients With Tardive Dyskinesia: Findings From the KINECT-PRO™ Study. CNS Spectr. Published online August 11, 2026. doi:10.1017/S1092852926101138
3. Farber RH, Stull DE, Witherspoon B, et al. The Tardive Dyskinesia Impact Scale (TDIS), a novel patient-reported outcome measure in tardive dyskinesia: development and psychometric validation. J Patient Rep Outcomes. 2024;8(1):2. Published 2024 Jan 4. doi:10.1186/s41687-023-00679-4
4. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017;174(5):476-484. doi:10.1176/appi.ajp.2017.16091037