Small Molecule · NBI-1070770

NBI-1070770

Phase 2Neurocrine Biosciences, Inc. (NBIX)

Investigational selective, orally active negative allosteric modulator of NR2B (GluN2B)-containing NMDA receptors, from Neurocrine Biosciences (licensed from Takeda), studied in major depressive disorder. Its Phase 2 study did not meet the primary endpoint (announced Nov 2025).

Also known as: NBI-1070770

Data current as of

Modality
Small molecule
Mechanism
GluN2B NAM
Highest phase
Phase 2
Lead indication
Major depressive disorder
Developer
Neurocrine Biosciences, Inc. (NBIX)
Trials
1 tracked · 13 sites

Mechanism of action

Selective, orally active negative allosteric modulator of the NR2B (GluN2B) subunit-containing NMDA receptor.

TargetActionAffinity
GluN2BprimaryGRIN2BNAM—ⓘ

Formulations

FormulationRouteRegimenPharmacokinetics
NBI-1070770 oral
Oral small-molecule NMDA NR2B (GluN2B) negative allosteric modulator; three dose strengths evaluated adjunctively in the Phase 2 MDD study (exact dose amounts not disclosed).
Oral——

Development timeline

Phase 2Apr 2024 – Nov 2025
  1. Phase 2 MDD study did NOT meet the primary endpoint vs placebo; generally well tolerated; next steps under analysis.↗
  2. First patient dosed in Phase 2 MDD study (NCT06267846).↗

NBI-1070770 for Major depressive disorder

Phase 2CompletedMajor depressive disorder indication →

Phase 2 adjunctive treatment of MDD (inadequate response to ≥1 antidepressant). The Phase 2 study (NCT06267846) did not meet its primary endpoint vs placebo; generally well tolerated. As of the Nov 10, 2025 update Neurocrine was analyzing results to determine next steps (not formally discontinued).

Clinical trials

NCT06267846NBI-1070770-MDD2029Phase 2Completedn=73

Phase 2 Study of NBI-1070770 in Adults With Major Depressive Disorder

Started Mar 2024· Primary completion Jul 2025· 📍 13 sites across 1 country (United States)

missedprimaryMADRS change vs placebo

Did not meet the primary endpoint vs placebo (announced Nov 10, 2025); drug generally well tolerated.

Related compounds

Other GluN2B compounds

More from Neurocrine Biosciences, Inc.

Identifiers

    Sources

    1. NBI-1070770 Phase 2 MDD (NCT06267846) — ClinicalTrials.gov
    2. Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder — Reference
    3. Neurocrine Biosciences Provides Update on Phase 2 Study of NBI-1070770 in Adults with Major Depressive Disorder — Neurocrine / PR Newswire