Recent Updates
Recently added Catalysts

NBI-1070770

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Neurocrine Biosciences, Inc.|Last Updated: Oct 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06267846A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive DisorderPHASE2 COMPLETED 73Mar 20, 2024Sep 11, 2025Oct 29, 202513 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
Baseline, Day 5
Secondary Endpoints
Change in Total MADRS Score from Baseline at Postbaseline Timepoints
Baseline, up to Day 49
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NBI-1070770: Low DoseEXPERIMENTALParticipants will receive low-dose NBI-1070770.
NBI-1070770: Medium DoseEXPERIMENTALParticipants will receive medium-dose NBI-1070770.
NBI-1070770: High DoseEXPERIMENTALParticipants will receive high-dose NBI-1070770.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo.
Interventions
NameTypeDescription
NBI-1070770DRUGSuspension for oral administration
PlaceboDRUGSuspension for oral administration
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria: Participants must meet all of the following inclusion criteria: * Primary diagnosis of recurrent MDD or persistent MDD. * Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior ...

Countries:United States
Unlock Eligibility Criteria