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NBI-1065890

Phase 2

Tardive Dyskinesia | Small molecule | Neurology |Neurocrine Biosciences, Inc.|Last Updated: Jun 23, 2026

Target and mechanism

Molecular targetVMAT2
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

NBI-1065890 · 1 trial · 1 indication

Phase 2 1
NCT07365462Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaTardive Dyskinesia
RECRUITING100 Analytics
PHASE2RECRUITING
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive DyskinesiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment
Baseline and Week 8

Secondary Endpoints

Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8
Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NBI-1065890EXPERIMENTALParticipants will receive NBI-1065890.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matching NBI-1065890.

Interventions

NameTypeDescription
NBI-1065890DRUGOral administration
PlaceboDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Key Inclusion Criteria: * Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening. * Medical...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJun 23, 2026NCT07365462lastUpdatePostDate: changed
LOWJun 23, 2026NCT07365462lastUpdatePostDate: changed

Frequently asked questions about NBI-1065890

What is NBI-1065890 used for?

NBI-1065890 is an investigational small molecule being developed for the treatment of tardive dyskinesia, a neurological condition characterized by involuntary movements. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does NBI-1065890 target?

NBI-1065890 targets the vesicular monoamine transporter 2 (VMAT2), a protein involved in the packaging and release of neurotransmitters. By modulating VMAT2 activity, the drug aims to address the abnormal movements associated with tardive dyskinesia.

Who makes NBI-1065890?

NBI-1065890 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with tardive dyskinesia.

What phase is NBI-1065890 in?

NBI-1065890 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is designed to assess its efficacy, safety, and tolerability in adults with tardive dyskinesia.

What clinical trials is NBI-1065890 in?

NBI-1065890 is being evaluated in a Phase 2 clinical trial registered as NCT07365462. This randomized, double-blind, placebo-controlled study is recruiting approximately 100 adults with tardive dyskinesia in the United States to compare the drug against placebo.

Is NBI-1065890 the same as other VMAT2 inhibitors?

NBI-1065890 is a distinct investigational compound targeting VMAT2. While other VMAT2 inhibitors exist for tardive dyskinesia, NBI-1065890 is a separate drug candidate developed by Neurocrine Biosciences. No alternative names for NBI-1065890 have been disclosed.