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NCT06966401Phase 3RECRUITING

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Study Summary

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Conditions
Major Depressive Disorder
Interventions / Drugs
NBI-1065845
View on ClinicalTrials.gov ↗
Sponsor
NBIX
Neurocrine Biosciences
Neuroscience
C58/100
Study Details
Enrollment600 participants
Primary Completion—
Lead SponsorNeurocrine Biosciences
Data Retrieved2026-04-11 04:22:17.614586+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 600 participants
Sponsor Catalyst Profile

Neurocrine Biosciences (NBIX) is the sponsoring company for this trial. BiotechSign currently grades this company C (58/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.