Neurocrine Biosciences announced the initiation of a Phase 2, randomized, double‑blind, placebo‑controlled study of its internally discovered VMAT2 inhibitor NBI‑1065890 in adults with tardive dyskinesia (TD). The trial, designated NBI‑1065890‑TD2033, will enroll roughly 100 subjects and will assess efficacy, safety and tolerability, with the primary endpoint being the change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at week 8.
NBI‑1065890 is positioned as a next‑generation, selective VMAT2 inhibitor that may offer a differentiated profile compared with Neurocrine’s existing FDA‑approved drug, valbenazine (INGREZZA). The company highlights that the new compound could provide improved efficacy, a more favorable safety profile or a longer dosing interval, potentially expanding the therapeutic options for patients who currently rely on valbenazine for TD and Huntington’s disease chorea.
The launch of this study underscores Neurocrine’s broader strategy to deepen its VMAT2 portfolio while diversifying its pipeline. INGREZZA remains the company’s revenue engine, with 2025 net product sales of $545 million and a full‑year guidance of $2.5‑$2.6 billion. In addition, the company has recently introduced CRENESSITY (crinecerfont) for congenital adrenal hyperplasia and is advancing programs such as osavampator for major depressive disorder and NBI‑568 for schizophrenia, signaling a concerted effort to broaden its therapeutic reach beyond movement disorders.
Chief Medical Officer Dr. Sanjay Keswani emphasized that advancing NBI‑1065890 to Phase 2 is a key step in defining the future of VMAT2 biology and delivering lasting impact for patients. Dr. Keswani, who joined Neurocrine as CMO in June 2025, noted that the study’s design and endpoints are aligned with regulatory expectations and that the company is confident in the compound’s potential to address unmet needs in the TD market, which serves an estimated 800,000 adults in the United States.
The initiation of a Phase 2 program signals a significant commercial opportunity for Neurocrine. The TD market is sizable and projected to grow, and a differentiated VMAT2 inhibitor could capture additional market share from competitors such as deutetrabenazine (AUSTEDO). By expanding its pipeline, Neurocrine aims to reinforce its leadership in movement disorders while mitigating reliance on a single product line.
Overall, the Phase 2 launch of NBI‑1065890 represents a strategic investment in Neurocrine’s core competency in VMAT2 biology and a proactive step toward sustaining long‑term growth in a high‑need therapeutic area.
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