Developer · Germany
Boehringer Ingelheim
Privately held global research-driven pharmaceutical company (Ingelheim am Rhein, Germany) with a CNS/psychiatry pipeline. Developed the PDE9A inhibitor BI 409306 (osoresnontrine) across schizophrenia, attenuated psychosis syndrome and Alzheimer's disease before refocusing its glutamatergic CNS efforts on the GlyT1 inhibitor iclepertin (BI 425809).
Pipeline (4)
- Major depressive disorderPhase 2Completed
- Major depressive disorderDiscontinuedDiscontinued
- SchizophreniaDiscontinuedDiscontinued
- SchizophreniaDiscontinuedDiscontinued
- Alzheimer's diseaseDiscontinuedDiscontinued
Catalysts · 0 upcoming · 7 reported
Recently reported
- 2025-12-01missed
Iclepertin (BI 425809)forSchizophreniaFull results
Pooled CONNEX Phase 3 results published in The Lancet Psychiatry: iclepertin no better than placebo on MCCB (p=0.63).
- 2025-01-16missed
Iclepertin (BI 425809)forSchizophreniaTopline data
Phase 3 CONNEX (CONNEX-1/-2/-3) missed primary (MCCB) and key secondary endpoints; iclepertin development in schizophrenia discontinued.
- 2024-01-10missed
BI 1358894forMajor depressive disorderFull results
BI 1358894 Phase 2 dose-ranging trial in MDD negative: no separation from placebo on MADRS at week 6
- 2022-04-19terminated
BI 1358894forMajor depressive disorderFull results
Decentralized BI 1358894 MDD trial terminated for deficient enrollment (45 of target randomized)
- 2022-04-04missed
OsoresnontrineforSchizophreniaFull results
Phase 2 relapse-prevention trial negative: incidence of first relapse over 28 weeks 48.2% on pooled BI 409306 vs 49.6% on placebo (pooled HR 0.910, 95% CI 0.468-1.770, p=0.78; 25 mg HR 1.097, 50 mg HR 0.910); no PANSS-positive or CGI-S benefit. Trial terminated early (n=264) citing COVID-19 disruption.
- 2018-05-02missed
OsoresnontrineforSchizophreniaFull results
Phase 2 CIAS trial negative: no significant difference between BI 409306 (any of four doses, 10-100 mg once daily) and placebo on MCCB composite score change at 12 weeks (1.2-2.8 vs 2.5), and no SCoRS benefit, in 518 randomized patients with schizophrenia.
- 2018-02-01missed
OsoresnontrineforAlzheimer's diseaseTopline data
Both Phase 2 Alzheimer's trials of BI 409306 missed their efficacy endpoints; Boehringer Ingelheim announced further AD development would not be pursued (pooled prespecified primary analysis, n=457: no significant change vs placebo in NTB total z-score at week 12, and no secondary-endpoint signal).
Recent activity
- Dec 1, 2025ReadoutIclepertin (BI 425809)·SchizophreniamissedPooled CONNEX Phase 3 results published in The Lancet Psychiatry: iclepertin no better than placebo on MCCB (p=0.63).source ↗
- May 2, 2025Phase changeBI 1569912·Major depressive disorderPhase 2Phase 2 monotherapy dose-finding trial (NCT06558344) reached primary completion.source ↗
- Feb 26, 2025Phase changeBI 1569912·Major depressive disorderPhase 2Phase 2 adjunctive dose-finding trial (NCT06280235) reached primary completion.source ↗
- Jan 16, 2025ReadoutIclepertin (BI 425809)·SchizophreniamissedPhase 3 CONNEX (CONNEX-1/-2/-3) missed primary (MCCB) and key secondary endpoints; iclepertin development in schizophrenia discontinued.source ↗
- Jan 10, 2024ReadoutBI 1358894·Major depressive disordermissedBI 1358894 Phase 2 dose-ranging trial in MDD negative: no separation from placebo on MADRS at week 6source ↗
- Apr 19, 2022ReadoutBI 1358894·Major depressive disorderterminatedDecentralized BI 1358894 MDD trial terminated for deficient enrollment (45 of target randomized)source ↗
- Apr 4, 2022ReadoutOsoresnontrine·SchizophreniamissedPhase 2 relapse-prevention trial negative: incidence of first relapse over 28 weeks 48.2% on pooled BI 409306 vs 49.6% on placebo (pooled HR 0.910, 95% CI 0.468-1.770, p=0.78; 25 mg HR 1.097, 50 mg HR 0.910); no PANSS-positive or CGI-S benefit. Trial terminated early (n=264) citing COVID-19 disruption.source ↗
- Aug 9, 2021Phase changeIclepertin (BI 425809)·SchizophreniaPhase 3Phase 3 CONNEX program initiated (CONNEX-1/-2/-3 plus the CONNEX-X open-label extension); iclepertin 10 mg once daily over 26 weeks adjunctive to stable antipsychotic treatment.source ↗
- Mar 31, 2021Phase changeOsoresnontrine·SchizophreniaDiscontinuedBoth remaining Phase 2 trials were terminated citing 'disruption due to COVID-19' (NCT03351244 completed 2021-03-31; NCT03230097 completed 2021-04-07), and the posted results show the relapse-prevention primary endpoint was missed (pooled HR 0.910, p=0.78). No formal discontinuation announcement exists; discontinuation is inferred from the terminations, the absence of any new BI 409306 trial since, the compound's absence from Boehringer's subsequent pipeline communications, and BI's own 2024 Schizophr Res paper describing development in the past tense. Date is the relapse trial's CT.gov completion date, an approximation of an undisclosed internal decision.source ↗
- Jun 25, 2020Phase changeIclepertin (BI 425809)·SchizophreniaPhase 2Phase 2 proof-of-concept (NCT02832037, n=509, 12 weeks) reported: iclepertin was well tolerated and significantly improved cognition (MCCB) vs placebo in CIAS, supporting Phase 3.source ↗
- May 2, 2018ReadoutOsoresnontrine·SchizophreniamissedPhase 2 CIAS trial negative: no significant difference between BI 409306 (any of four doses, 10-100 mg once daily) and placebo on MCCB composite score change at 12 weeks (1.2-2.8 vs 2.5), and no SCoRS benefit, in 518 randomized patients with schizophrenia.source ↗
- Feb 1, 2018Phase changeOsoresnontrine·SchizophreniaPhase 2After the Alzheimer's Phase 2 trials missed their endpoints, Boehringer Ingelheim announced it was refocusing PDE9 inhibition brain research on schizophrenia (press release, February 2018) — the relapse-prevention trial NCT03351244 (started 2017-12-07) and the attenuated psychosis syndrome trial NCT03230097 (started 2017-09-29) became the program's remaining bets, despite the CIAS trial having already missed its own primary endpoint. Date carries month precision; the release's exact day is not stated on the archived page.source ↗
Trials recruiting · 1 recruiting of 60 sponsored
- Phase 1BI 3031185, Placebo
A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
Competitive landscape
Other companies developing against Boehringer Ingelheim's targets or indications.
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- Eli Lilly and Company2 compoundsSchizophreniaAlzheimer's disease
- F. Hoffmann-La Roche Ltd2 compoundsSchizophreniaAlzheimer's disease
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- LB Pharmaceuticals Inc.1 compoundMajor depressive disorderSchizophrenia
- Merck & Co., Inc.3 compoundsSchizophreniaAlzheimer's disease
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- Syndeio Biosciences, Inc.2 compoundsGluN2BMajor depressive disorder
- Vanda Pharmaceuticals Inc.2 compoundsMajor depressive disorderSchizophrenia