Valbenazine Linked to Better Physical and Emotional Well-Being in Tardive Dyskinesia

Newly presented data from KINECT-PRO, a phase 4 post-marketing study, showed that treatment with valbenazine (Ingrezza; Neurocrine Biosciences), an FDA-approved VMAT2 inhibitor, led to positive, real-world changes in physical, social, and emotional outcomes in patients with tardive dyskinesia (TD).¹

Presented at the 2025 International Parkinson and Movement Disorders Society Congress (MDS), held September 5-10 in Hawaii, the open-label study comprised a 4-week screening period, followed by a 4-week initial loading phase, and a 12-week treatment period. Patients began treatment with 40 mg of valbenazine during the loading phase, with the option to either remain on that dose or increase to 60 mg or 80 mg. Coming into the study, patients had at least mild TD severity, per Abnormal Involuntary Movement Scale (AIMS) item 8, and mild or worse associated distress from their dyskinetic movements (AIMS item 10).

Led by Joseph McEvoy, MD, Case Distinguished Chair in Psychotic Disorders, at the Medical College of Georgia, 52 of the originally enrolled 59 participants (mild TD: n = 24; mod/severe TD: n = 35) completed week 24 visit, with 45 included in the efficacy analyses. After 24 weeks of treatment, those on valbenazine saw several positive impacts on a number of patient-reported outcome (PRO) measures, with these changes observed as early as week 4.

After 24 weeks, investigators reported mean changes of –6.8, –8.9, and –8.0 in Tardive Dyskinesia Impact Scale (TDIS) for the mild, moderate/severe, and overall cohorts, respectively. On Sheehan Disability Scale (SDS), these groups reported mean changes of –1.8, –2.8, and –2.3 for social life, and –1.3, –1.8, and –1.6 for family life. In addition, positive impacts were seen on EQ-5D-5L visual analog scale (+12.8, +13.3, and +13.1).

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Each of these PROs slightly differs: the TDIS captures the specific impact of tardive dyskinesia on daily function and well-being, while the SDS evaluates broader disability across work, social, and family life. In contrast, the EQ-5D-5L VAS provides a single, patient-rated measure of overall health, allowing comparisons across different conditions and treatments. Authors noted that this was the first study to report the effects of a VMAT2 inhibitor on the physical, social, and emotional aspects of TD using multiple PROs.

Additional data from the study showed that at week 24, mean changes in AIMS total scores were –5.6 for mild patients, –7.8 for moderate to severe patients, and –6.8 for the overall cohort. Valbenazine, originally approved in 2017 for patients with TD, had safety findings that were consistent with known safety and tolerability profile for the medication.

Years later after its original approval, in 2023, the FDA expanded valbenazine’s indication to include the treatment of chorea associated with Huntington disease, making it the only VMAT2 inhibitor approved for this condition. Led then a year later, the agency approved a new sprinkle formulation for valbenazine, giving patients greater flexibility in dosing options. To date, the oral granules capsules, which come in 40 mg, 60, or 80 doses, are intended to be opened for sprinkling on soft foods prior to administration.^2,3

Earlier this year, a published paper pooling the KINECT-3 extension (NCT02274558) and KINECT-4 (NCT02405091) studies of valbenazine provided further support for the therapy in elderly patients with TD. Over a 48-week treatment period, patients at least 65 years or older saw improvements in clinician assessments and patient reports, with no impact on psychiatric stability. On AIMS total score, investigators recorded mean changes of –4.5, (±0.7; n = 50), –8.6 (±0.9; n = 26), and –8.8 (±0.9; n = 28), respectively, at weeks 8, 24, and 48.4.⁴

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REFERENCES
1. Dunayevich E, Parameswaran A, Bron M, et al. Valbenazine Improves the Burden and Symptoms of Tardive Dyskinesia: Topline Results from the Phase 4 KINECT-PRO Study. Presented at: 2025 MDS Congress; October 5-10; Hawaii.
2. Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease. News Release. Neurocrine Biosciences. Published August 18, 2023. Accessed August 18, 2023.
3. Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules. News release. Neurocrine. April 30, 2024. Accessed October 3, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-us-fda-approval-of-ingrezza-sprinkle-valbenazine-capsules-302132283.html
4. Sajatovic M, Alexopoulos GS, Jen E, Farahmand K, Zinger C. Improvements Over Time with Valbenazine in Elderly Adults (≥65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies. J. Clin Psychiatry. 2025;86(2):24m15550.