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NBI-1065890

Phase 2

Tardive Dyskinesia | Small molecule | Dermatology |Neurocrine Biosciences, Inc.|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07365462Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaPHASE2 RECRUITING 100Feb 6, 2026Mar 1, 2027May 19, 202617 United States
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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 — 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

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)
LOWMay 26, 2026NCT07365462Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07365462studyFirstPostDate: changed