Neurocrine Biosciences’ Kinect 4 open-label study (NCT02405091) found that 59.2% of patients achieved remission of tardive dyskinesia through once-daily doses of Ingrezza (valbenazine).
Post-hoc analysis from the trial found that while only 103 patients out of the initially recruited 163 patients completed the trial, 57.7% of patients with schizophrenia and 62.5% of participants with mood disorders were able to reach remission.
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Patients from 48 clinical sites across the US and Canada were split into two arms, receiving either 40mg or 80mg of Ingrezza through the 48-week trial. Of those who completed the trial, 58.6% of patients on 40mg reached remission while the 80mg group saw 59.5% doing the same.
Results from the open-label safety and tolerability study were announced as part of the 2025 Psychiatry Update Conference in Chicago, US. The threshold for what was defined as remission was set at a less than one point score in each of the categories measured via the Abnormal Involuntary Movement Scale (AIMS) score system.
Neurocrine Biosciences’ chief medical officer Eiry Roberts said: “These findings further establish Ingrezza as a highly effective long-term treatment option for individuals living with tardive dyskinesia, regardless of their underlying psychiatric condition, including schizophrenia, or schizoaffective or mood disorder.
“The significant improvements observed in AIMS score and the high remission rates highlight the efficacy of Ingrezza, at even the lowest dose.”
Research published in the journal Neurotherapeutics estimates that the condition affects approximately 600,000 people across the US, with the risk increasing with age.
Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor designed to inhibit the release of dopamine.
GlobalData’s Pharmaceutical Intelligence Center found that the global tardive dyskinesia market brought in $3.9bn last year, with Ingrezza itself making up $2.3bn of that amount. Ingrezza is expected to bring in approximately $6.2bn for the company by the end of the decade. Following closely behind is Teva Pharmaceutical’s Austedo (deutetrabenazine), which earned $1.6bn in 2024.
GlobalData is the parent company of Clinical Trials Arena.
Away from tardive dyskinesia, the company has launched another separate trial examining another VMAT2 inhibitor, NBI-1140675. Meanwhile, German healthcare giant Boehringer Ingelheim’s schizophrenia drug iclepertin missed all primary and secondary endpoints in three Phase III studies.
