BI 1569912 / Boehringer Ingelheim - LARVOL DELTA

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

NMDA subunit 2B-selective negative allosteric modulator satoprodil (BI 1569912) as mono- and adjunctive therapy in patients with major depressive disorder: results from two phase 2 randomized, controlled trials. (PubMed, Neuropsychopharmacology) - "In patients with MDD, satoprodil (all doses) over 6-weeks was well tolerated but did not reduce depressive symptoms beyond placebo in either trial in a relevant manner. These trials provide the most comprehensive clinical evidence to date on GluN2B-selective modulation in MDD and will inform future research on glutamatergic pathways."

Journal • P2 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • GRIN2B

Safety, tolerability and pharmacokinetics of an NMDA receptor subunit 2B-selective negative allosteric modulator, BI 1569912: Results of three partially randomised, placebo-controlled phase I trials. (PubMed, J Psychopharmacol) - P1 | "BI 1569912 demonstrated favourable safety and PK profiles in healthy participants.Clinical trial registration: Trial 1 (ClinicalTrials.gov: NCT04445090 (1447-0001)); Trial 2 (ClinicalTrials.gov: NCT04978506 (1447-0002)); Trial 3 (ClinicalTrials.gov: NCT04958252 (1447-0004))."

Journal • P1 data • PK/PD data • GRIN2B

A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - P2 | N=243 | Completed | Sponsor: Boehringer Ingelheim | N=84 ➔ 243

Enrollment change • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Safety and Efficacy of the NMDA-2b-Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder. (PubMed, Clin Pharmacol Ther) - "The maximum decrease from baseline in MADRS within a 7-day interval was similar across groups; however, a single BI 1569912 20-mg dose provided a clinically relevant 3.4- to 4.9-point improvement in MADRS total score vs. placebo at Days 2, 4, and 6, meeting predefined criteria for further development. The favorable safety profile and preliminary efficacy signals support continued development of BI 1569912 for adults with MDD."

Clinical • Journal • P1 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Test Different Doses of BI 1569912 in People With Depression (clinicaltrials.gov) - P2 | N=224 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - P2 | N=84 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Test Different Doses of BI 1569912 in People With Depression (clinicaltrials.gov) - P2 | N=224 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | N=204 ➔ 84

Enrollment change • Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Test Different Doses of BI 1569912 in People With Depression (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2025 ➔ May 2025 | Trial primary completion date: Oct 2025 ➔ May 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2025 ➔ Feb 2025 | Trial primary completion date: Aug 2025 ➔ Feb 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Test Different Doses of BI 1569912 in People With Depression (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Test Different Doses of BI 1569912 in People With Depression (clinicaltrials.gov) - P2 | N=222 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - P1 | N=76 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry