New Post-Hoc Analysis: Treatment With Ingrezza Results in Earlier Remission of Tardive Dyskinesia Symptoms and Reduced Disease Burden

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Neurocrine Biosciences today announced new data from a post-hoc analysis of the phase 4 KINECT-PRO open-label study that confirms robust rates of symptomatic remission of tardive dyskinesia (TD) were achieved with once-daily valbenazine (Ingrezza) capsules. The analysis also showed sustained improvements in patient-reported outcomes among participants who achieved symptomatic remission.

KINECT-PRO is the first and only study to evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment, specifically Ingrezza, on TD using multiple clinically validated scales. These results were presented at Psych Congress 2025 in San Diego, CA.

In the post-hoc analysis of KINECT-PRO, investigators included data from patients with mild to severe TD severity and awareness with mild to severe associated distress, as measured by the Abnormal Involuntary Movement Scale (AIMS) items 8 and 10 at baseline. Patients received an initial 40 mg dose of once-daily Ingrezza for 4 weeks, with the option to adjust the dose to 60 mg or 80 mg through week 16, followed by a stable dose through week 24. At week 24, 26 of 45 patients (57.8%) achieved the remission threshold, including 58.3% at 40 mg, 44.4% at 60 mg, and 62.5% at 80 mg. The threshold for remission of TD symptoms was defined as an AIMS score of ≤1 ("minimal" or "none") in each body region (items 1-7).

For patients meeting the symptomatic remission threshold, changes from baseline were evaluated using 3 validated patient-reported outcomes (PROs): the Tardive Dyskinesia Impact Scale, the Sheehan Disability Scale, and the EuroQoL Visual Analog Scale. After 24 weeks of treatment with Ingrezza, these results demonstrated robust and sustained improvements in TD impact, functional impairment, and health-related quality of life.

"These new analyses from KINECT-PRO demonstrated that symptomatic remission from the uncontrollable movements of tardive dyskinesia can be achieved with Ingrezza treatment even sooner than previously available data suggested, regardless of whether these movements were mild or more severe prior to treatment," said Sanjay Keswani, MD, the chief medical officer of Neurocrine Biosciences. "Additionally, the data indicate that patients who achieved remission of tardive dyskinesia symptoms, defined as minimal or no involuntary movements, experienced substantial and meaningful improvements in how tardive dyskinesia affects them physically, socially, and emotionally. This reinforces symptomatic remission as an important treatment goal achievable with Ingrezza."

In terms of safety profile, Ingrezza’s safety and tolerability of treatment was consistent with the known profile of and no new concerns identified.

This post-hoc analysis demonstrated high rates of symptomatic remission and associated improvements in PROs, including physical and socioemotional impacts of TD. These findings add to the unique and growing body of evidence supporting the efficacy of Ingrezza in TD severity and impact, as well as its potential to achieve remission of TD symptoms.

This research builds upon previous findings that demonstrate Ingrezza’s utility in improving health-related quality of life measures for patients with TD. Earlier this year, Neurocrine Biosciences shared analyses at the 2025 International Society for Pharmacoeconomics and Outcomes Research Conference from a phase 4 randomized withdrawal study showing participants with TD who received continued treatment with Ingrezza capsules demonstrated functional and health-related quality of life improvements. Significant enhancements in work/school, social life, and family/home life were observed with Ingrezza treatment.²

References

1. Neurocrine Biosciences presents new post-hoc analysis: treatment with Ingrezza® (valbenazine) capsules achieves earlier remission of tardive dyskinesia symptoms while reducing patient-reported disease burden. News release. September 23, 2025. Accessed September 23, 2025. https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-new-post-hoc-analysis-treatment

2. Kuntz L. New Ingrezza data demonstrates functional and quality of life improvements in patients with tardive dyskinesia. Psychiatric Times. May 16, 2025. https://www.psychiatrictimes.com/view/new-ingrezza-data-demonstrates-functional-and-quality-of-life-improvements-in-patients-with-tardive-dyskinesia