NBI-1065890 / Neurocrine Biosciences - LARVOL DELTA

Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P2 trial • Movement Disorders

Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1065890 in Adults with Tardive Dyskinesia (PRNewswire) - "This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects with TD and will assess the efficacy, safety, and tolerability of NBI-1065890 compared with placebo. The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of Items 1–7) at Week 8."

New P2 trial • CNS Disorders

Details of Neurocrine's transformed R&D engine, designed to deliver at least four new Phase 1 and two Phase 2 programs per year by focusing on genetically or clinically validated mechanisms of action were shared during today's event. Highlighted programs include: (PRNewswire) - "NBI-'569, a dual M1 / M4 agonist for Alzheimer's psychosis, and NBI-'567, an M1 preferring agonist for Alzheimer's cognition and Lewy body dementia; Next-generation VMAT2 inhibitors; NBI-'890 and NBI-'675, engineered for increased half-life and potency and decreased solubility, and which provide the potential for long-acting injectable administration across multiple central nervous system indications; A suite of differentiated assets for better quality weight loss, including NBIP-'2118, a CRF2 agonist expected to enter Phase 1 development in the first half of 2026....Neurocrine plans to provide update on its emerging early-stage Neurology and Immunology pipeline in 2026."

New P1 trial • Pipeline update • Alzheimer's Disease • Dementia • Lewy Body Disease • Obesity