Neurocrine Biosciences has started a Phase II clinical trial of NBI-1065890, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, in adults with tardive dyskinesia (TD).
TD is characterised by involuntary, repetitive movements affecting the torso, face or other body parts.
The double-blind, placebo-controlled and randomised Phase II study aims to assess the efficacy, tolerability, and safety of this investigational compound in TD, a movement disorder often linked to prolonged use of antipsychotic medications.
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It is enrolling nearly 100 adults with TD. The main efficacy endpoint is the change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at week eight.
Neurocrine previously developed valbenazine, which received the US Food and Drug Administration (FDA) approval in 2017 as the first therapy for TD. Valbenazine was also approved in 2023 for chorea associated with Huntington’s disease.
NBI-1065890 was developed and discovered internally at Neurocrine Biosciences. It is administered orally and is currently in clinical development for treating TD.
VMAT2 inhibition may offer therapeutic benefits in TD and other hyperkinetic movement or central nervous system disorders involving disrupted dopaminergic signalling.
Neurocrine Biosciences’ chief medical officer Sanjay Keswani said: “NBI-‘890 is an internally discovered molecule with distinct physical and chemical properties that may allow it to benefit a broader range of patients with tardive dyskinesia.
“Advancing this programme to a Phase II clinical study is key to our strategy to define the future of VMAT2 biology and deliver lasting impact for patients.”
In December 2025, Neurocrine reported that its Phase III trial evaluating the selective VMAT2 inhibitor, valbenazine, in paediatric and adult patients with dyskinetic cerebral palsy did not meet the endpoints.
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