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NBI-1070770

Phase 2

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

NBI-1070770 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2024

NBI-1070770 target and mechanism

Molecular targetGPR139
Target classGene
ModalitySmall molecule

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

NBI-1070770 clinical trials

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?

NBI-1070770 is an investigational small molecule being developed by Neurocrine Biosciences for the treatment of major depressive disorder. It is a GPR139-targeted compound and has been studied in a Phase 2 clinical trial. It is not approved for any indication and remains in clinical development.

What is NBI-1070770 used for?

NBI-1070770 is being evaluated for the treatment of major depressive disorder in adults. It is an investigational therapy and has not been approved for any use. The clinical program has focused on adults aged 18 years and older with a diagnosis of major depressive disorder.

What does NBI-1070770 target?

NBI-1070770 targets GPR139, an orphan G protein-coupled receptor. By interacting with this receptor, the drug is designed to modulate a specific signaling pathway relevant to major depressive disorder. GPR139 is the molecular target of the compound.

Who is developing NBI-1070770?

NBI-1070770 is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company is the sponsor of the clinical program evaluating the drug in major depressive disorder.

What phase is NBI-1070770 in?

NBI-1070770 is in Phase 2 clinical development. A Phase 2 trial in adults with major depressive disorder has been completed. The drug is investigational and has not been approved by the FDA or any regulatory authority for any indication.

What clinical trials is NBI-1070770 in?

NBI-1070770 has been studied in one Phase 2 clinical trial, NCT06267846, titled A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder. The trial was completed, enrolled 73 participants, and was randomized, double-blind, and placebo-controlled, conducted in the United States.