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NBI-1070770

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Neurocrine Biosciences, Inc.|Last Updated: Jul 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

NBI-1070770 · 1 trial · 1 indication

Phase 2 1
NCT06267846A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive DisorderMajor Depressive Disorder
COMPLETED73 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Recent Changes (Last 90 Days)

MEDIUMAug 17, 2026NCT06267846TRIAL_REMOVED: changed
MEDIUMAug 17, 2026NCT06267846TRIAL_REMOVED: changed
MEDIUMAug 17, 2026NCT06267846TRIAL_REMOVED: changed

Frequently asked questions about NBI-1070770

What is NBI-1070770 used for?

NBI-1070770 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adults with MDD to evaluate its efficacy and safety.

Who makes NBI-1070770?

NBI-1070770 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 potential as a treatment for Major Depressive Disorder.

What phase is NBI-1070770 in?

NBI-1070770 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for its efficacy and safety in treating Major Depressive Disorder.

What clinical trials is NBI-1070770 in?

NBI-1070770 has one completed clinical trial, registered as NCT06267846, titled 'A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder.' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 73 participants in the United States.

Is NBI-1070770 FDA approved?

No, NBI-1070770 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval and remains under clinical investigation.