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NBI-1117570

Phase 2

Schizophrenia | Small molecule | Psychiatry |Neurocrine Biosciences, Inc.|Last Updated: May 26, 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 Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07288333Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaPHASE2 RECRUITING 120Feb 16, 2026Aug 1, 2027May 26, 20265 Bulgaria, United Kingdom
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Study Endpoints
Primary Endpoints
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
Day 35
Secondary Endpoints
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Day 1 up to Day 49
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NBI-1117570: Lower-doseEXPERIMENTALParticipants will receive a lower-dose of NBI-1117570.
NBI-1117570: Higher-doseEXPERIMENTALParticipants will receive a higher-dose of NBI-1117570.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to NBI-1117570.
Interventions
NameTypeDescription
NBI-1117570DRUGOral administration
PlaceboDRUGOral administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: * 18 to 55 years of age * Primary diagnosis of schizophrenia ≥1 year before screening. * Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization. * Participant must have ha...

Countries:BulgariaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07288333lastUpdatePostDate: changed
LOWMay 27, 2026NCT07288333lastUpdatePostDate: changed
LOWMay 26, 2026NCT07288333Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07288333studyFirstPostDate: changed