Drugs / BI 425809
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 117 trials · 1 missed | ||||||
| Phase 1 | NCT05723874 | Mar → May 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05718843 | Feb → Oct 2023 | impaired renal function disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05347004 | Oct → Dec 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05076409 | Oct 2021 → Jan 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT04602221 | Dec 2020 → Aug 2022 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT03988803 | Jul → Oct 2019 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03905096 | Apr → Aug 2019 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03817476 | Feb → May 2019 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03783000 | Jan → Mar 2019 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03654170 | Sep → Nov 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03082183 | Mar → Jun 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02783040 | Sep → Oct 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02383888 | May → Aug 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02362516 | Feb → Jun 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02342717 | Jan → Mar 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02337283 | Jan → Nov 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02068690 | Mar → Sep 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT03859973 | Apr 2019 → Sep 2022 | schizophrenia | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT02788513 | Aug 2016 → Sep 2019 | Alzheimer disease | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT02832037 | Jul 2016 → Dec 2019 | schizophrenia | Boehringer Ingelheim | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-05-24 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim's Investigational Treatment for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation prnewswire.com ↗
Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for BI 425809 for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). |
| 2020-09-14 | Boehringer Ingelheim | Results Phase II trial results demonstrated improvement in cognition with BI 425809 in adult patients with schizophrenia prnewswire.com ↗
Boehringer Ingelheim today announced the results from a 12-week, placebo-controlled Phase II trial, that demonstrate BI 425809 met its primary endpoint. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-05-24 | Boehringer Ingelheim | Boehringer Ingelheim's Investigational Treatment for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation prnewswire.com ↗ |
| 2020-09-14 | Boehringer Ingelheim | Phase II trial results demonstrated improvement in cognition with BI 425809 in adult patients with schizophrenia prnewswire.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI 425809 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05347004 ↗ |
| Known as | Iclepertin | “This substudy from a Phase II, randomized, double-blind, placebo-controlled, parallel-group study investigating the safety and efficacy of the novel glycine transporter-1...” PMID 35953474 ↗ Aug 20221“Iclepertin” NCT05347004 ↗ |
| Action | Inhibit | “Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers” PMID 29076028 ↗ Apr 2018 |
| Route | Oral | “Single Rising Oral Doses of BI 425809 in Healthy Male Subjects” NCT02068690 ↗ |