Small Molecule · BI 1569912

BI 1569912

Phase 2Boehringer Ingelheim International GmbH

Oral selective negative allosteric modulator of GluN2B (NR2B)-containing NMDA receptors, from Boehringer Ingelheim, for major depressive disorder. A Phase Ib trial reported a 3.4–4.9 point MADRS improvement vs placebo at 20 mg; two Phase 2 dose-finding trials (adjunctive and monotherapy) completed in 2025.

Also known as: BI 1569912, BI-1569912

Data current as of

Modality
Small molecule
Mechanism
GluN2B NAM
Highest phase
Phase 2
Lead indication
Major depressive disorder
Developer
Boehringer Ingelheim International GmbH
Trials
2 tracked · 93 sites

Mechanism of action

Selective negative allosteric modulator of NR2B (GluN2B)-containing NMDA receptors — a glutamatergic mechanism hypothesized to give rapid antidepressant effects with a differentiated tolerability profile.

TargetActionAffinity
GluN2BprimaryGRIN2BNAM—ⓘ

Formulations

FormulationRouteRegimenPharmacokinetics
BI 1569912 oral tablet
Immediate-release tablet; 5 mg and 20 mg single doses evaluated in the Phase Ib MDD trial (as adjunct to ongoing SSRI/SNRI), administered under fasted conditions
OralSingle dose—

Development timeline

Phase 2Feb 2025 – May 2025
  1. Phase 2 monotherapy dose-finding trial (NCT06558344) reached primary completion.
  2. Phase 2 adjunctive dose-finding trial (NCT06280235) reached primary completion.

BI 1569912 for Major depressive disorder

Phase 2CompletedMajor depressive disorder indication →

BI 1569912 for MDD. Phase Ib adjunctive trial met criteria for continued development (MADRS improvement 3.4–4.9 points vs placebo at 20 mg). Two Phase 2 6-week dose-finding trials (5/10/20 mg) completed in 2025 — adjunctive (NCT06280235) and monotherapy (NCT06558344). Phase 2 topline not yet located.

Clinical trials

NCT065583441447-0012Phase 2Completedn=225

Phase 2 Dose-Finding Trial of Oral BI 1569912 (Monotherapy) in Major Depressive Disorder

Started Oct 2024· Primary completion May 2025· 📍 41 sites across 2 countries (United States, Japan)

NCT06280235Phase 2Completedn=243

Phase 2 Dose-Finding Trial of BI 1569912 as Adjunctive Therapy in Major Depressive Disorder

Started Mar 2024· Primary completion Feb 2025· 📍 52 sites across 7 countries (United States, Japan, China, Bulgaria)

Related compounds

Other GluN2B compounds

More from Boehringer Ingelheim International GmbH

Identifiers

    Sources

    1. BI 1569912 adjunctive Phase 2 (NCT06280235) — ClinicalTrials.gov
    2. BI 1569912 monotherapy Phase 2 (NCT06558344) — ClinicalTrials.gov
    3. Safety and Efficacy of the NMDA-2b-Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder — Clinical Pharmacology & Therapeutics
    4. Safety and Efficacy of the NMDA-2b-Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder — Clinical Pharmacology & Therapeutics (PMC)