BI 1569912 · program

BI 1569912 for Major depressive disorder

Phase 2CompletedBoehringer Ingelheim International GmbH

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.

Data current as of

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.

Clinical trials in Major depressive disorder

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)

NCT04937829Phase 1Completedn=59

A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication

Started Jul 2021· Primary completion Nov 2023· 📍 10 sites across 1 country (United States)

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—

Mechanism of action (compound-wide)

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—ⓘ

← Full BI 1569912 compound page (identity, identifiers, all indications)

Sources

  1. BI 1569912 adjunctive Phase 2 (NCT06280235) — ClinicalTrials.gov
  2. BI 1569912 monotherapy Phase 2 (NCT06558344) — ClinicalTrials.gov
  3. clinicaltrials.gov — clinicaltrials.gov
  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
  5. 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)