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Trials |  |
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- | ETD001 / Enterprise Therap
Preclinical, Journal: ETD001: A novel inhaled ENaC blocker with an extended duration of action in vivo. (Pubmed Central) - Jun 9, 2024
These data support that the ENaC blocker hypothesis is yet to be appropriately tested in pwCF. ETD001 has a profile that enables dosing at a level sufficient to provide a long duration of action in a Phase 2 clinical study in pwCF scheduled for 2024.
- | BI 1265162 / Boehringer Ingelheim
Journal: Discovery and development of BI 1265162, an ENaC inhibitor for the treatment of cystic fibrosis. (Pubmed Central) - Jan 17, 2024
A phase 2 study with BI 1265162 did not provide a clear sign of clinical benefit. Whether ENaC inhibition will be able to hold its promise for CF patients remains an open question.
- || BI 1265162 / Boehringer Ingelheim
Clinical, P2 data, Journal: Efficacy and safety of inhaled ENaC inhibitor BI 1265162 in patients with cystic fibrosis: BALANCE-CF™ 1 - a randomised, Phase II study. (Pubmed Central) - Apr 7, 2022
BI 1265162 was safe, but did not demonstrate a potential for clinical benefit. Development has been terminated.
- BI 1265162 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Mar 23, 2021
P1, N=7, Terminated, Sponsor: Boehringer Ingelheim
Development has been terminated. Trial completion date: Dec 2020 --> Apr 2020 | Trial primary completion date: Dec 2020 --> Apr 2020
- BI 1265162 / Boehringer Ingelheim
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Mar 18, 2021
P1, N=7, Terminated, Sponsor: Boehringer Ingelheim
N=16 --> 7 | Trial completion date: Jun 2021 --> Dec 2020 | Suspended --> Terminated | Trial primary completion date: Jun 2021 --> Dec 2020; Due to the COVID-19 pandemic, the recruitment of new subjects was temporarily halted in March 2020. The study was permanently discontinued in December 2020.
- || BI 1265162 / Boehringer Ingelheim
Clinical, Journal: First clinical trials of the inhaled epithelial sodium channel inhibitor BI 1265162 in healthy volunteers. (Pubmed Central) - Feb 12, 2021
P1
Accumulation was minimal. Twice-daily dosing is supported for future development.
- || BI 1265162 / Boehringer Ingelheim
Clinical, P2 data, Journal: An innovative phase II trial to establish proof of efficacy and optimal dose of a new inhaled epithelial sodium channel inhibitor BI 1265162 in adults and adolescents with cystic fibrosis: BALANCE-CF 1. (Pubmed Central) - Dec 17, 2020
P2
The design ensures that potential for effect is assessed ahead of wider enrolment, allowing investigation of a dose-response effect with minimal patient numbers. The results will increase understanding of efficacy, safety and optimal dosing of the inhaled ENaC inhibitor BI 1265162 in adults and adolescents with CF.
- | BI 1265162 / Boehringer Ingelheim
Preclinical, Journal: Preclinical evaluation of the epithelial sodium channel inhibitor BI 1265162 for treatment of cystic fibrosis. (Pubmed Central) - Dec 17, 2020
BI 1265162 alone and in combination with CF transmembrane conductance regulator (CFTR) modulators decreased water transport and increased MCC in both normal and CF airway human epithelial models and also increased the effects of CFTR modulators in CF epithelium to reach the effect size seen in healthy epithelium with ivacaftor/lumacaftor alone. These results demonstrate the potential of BI 1265162 as a mutation agnostic, ENaC-inhibitor-based therapy for CF.
- BI 1265162 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Nov 5, 2020
P1, N=16, Suspended, Sponsor: Boehringer Ingelheim
These results demonstrate the potential of BI 1265162 as a mutation agnostic, ENaC-inhibitor-based therapy for CF. Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Jan 2021 --> Jun 2021
- BI 1265162 / Boehringer Ingelheim
An update on BALANCE-CF™ 1: a Phase II trial of the inhaled ENaC inhibitor BI 1265162 in adults and adolescents with cystic fibrosis () - Jun 29, 2020 - Abstract #ECFS2020ECFS_392;
P2
Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Jan 2021 --> Jun 2021 BALANCE-CF™ 1 will increase understanding of efficacy, safety and optimal dosing of BI 1265162 in patients with CFaged≥12 years.
- BI 1265162 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Jun 17, 2020
P1, N=16, Suspended, Sponsor: Boehringer Ingelheim
BALANCE-CF™ 1 will increase understanding of efficacy, safety and optimal dosing of BI 1265162 in patients with CFaged≥12 years. Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020
- | BI 1265162 / Boehringer Ingelheim
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat (clinicaltrials.gov) - May 21, 2020
P2, N=52, Terminated, Sponsor: Boehringer Ingelheim
Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020 N=98 --> 52 | Trial completion date: Sep 2020 --> Apr 2020 | Suspended --> Terminated | Trial primary completion date: Sep 2020 --> Apr 2020; Not due to safety reasons
- ||| BI 1265162 / Boehringer Ingelheim
Trial completion date, Trial suspension, Trial primary completion date: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Apr 6, 2020
P1, N=16, Suspended, Sponsor: Boehringer Ingelheim
N=98 --> 52 | Trial completion date: Sep 2020 --> Apr 2020 | Suspended --> Terminated | Trial primary completion date: Sep 2020 --> Apr 2020; Not due to safety reasons Trial completion date: Apr 2020 --> Jul 2020 | Recruiting --> Suspended | Trial primary completion date: Apr 2020 --> Jul 2020
- ||||| BI 1265162 / Boehringer Ingelheim
Trial suspension: A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat (clinicaltrials.gov) - Apr 5, 2020
P2, N=98, Suspended, Sponsor: Boehringer Ingelheim
Trial completion date: Apr 2020 --> Jul 2020 | Recruiting --> Suspended | Trial primary completion date: Apr 2020 --> Jul 2020 Recruiting --> Suspended
- || BI 1265162 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Feb 19, 2020
P1, N=16, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Suspended Not yet recruiting --> Recruiting
- || BI 1265162 / Boehringer Ingelheim
New P1 trial: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body (clinicaltrials.gov) - Feb 11, 2020
P1, N=16, Not yet recruiting, Sponsor: Boehringer Ingelheim
- || BI 1265162 / Boehringer Ingelheim
Trial completion: A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood (clinicaltrials.gov) - Jan 18, 2020
P1, N=12, Completed, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || BI 1265162 / Boehringer Ingelheim
Enrollment closed: A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood (clinicaltrials.gov) - Nov 1, 2019
P1, N=12, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | BI 1265162 / Boehringer Ingelheim
Enrollment open: A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat (clinicaltrials.gov) - Sep 18, 2019
P2, N=98, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | BI 1265162 / Boehringer Ingelheim
New P2 trial: A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat (clinicaltrials.gov) - Aug 15, 2019
P2, N=98, Not yet recruiting, Sponsor: Boehringer Ingelheim
- | BI 1265162 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood (clinicaltrials.gov) - May 29, 2019
P1, N=12, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Trial completion date: Jun 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019
- || BI 1265162 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood (clinicaltrials.gov) - Apr 24, 2019
P1, N=12, Recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Jun 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019 Not yet recruiting --> Recruiting
- || BI 1265162 / Boehringer Ingelheim
New P1 trial: A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood (clinicaltrials.gov) - Apr 8, 2019
P1, N=12, Not yet recruiting, Sponsor: Boehringer Ingelheim
- || BI 1265162 / Boehringer Ingelheim
Trial completion: This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated. (clinicaltrials.gov) - Dec 10, 2018
P1, N=45, Completed, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | BI 1265162 / Boehringer Ingelheim
Enrollment closed: This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated. (clinicaltrials.gov) - Nov 29, 2018
P1, N=45, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || BI 1265162 / Boehringer Ingelheim
Enrollment open: This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated. (clinicaltrials.gov) - Jul 16, 2018
P1, N=50, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || BI 1265162 / Boehringer Ingelheim
New P1 trial: This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated. (clinicaltrials.gov) - Jul 2, 2018
P1, N=50, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| BI 1265162 / Boehringer Ingelheim
Trial completion, Trial completion date, Trial primary completion date: This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men (clinicaltrials.gov) - Mar 7, 2018
P1, N=53, Completed, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Feb 2018 --> Mar 2018 | Trial primary completion date: Feb 2018 --> Mar 2018
- ||| BI 1265162 / Boehringer Ingelheim
Enrollment open: This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men (clinicaltrials.gov) - Nov 29, 2017
P1, N=56, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Completed | Trial completion date: Feb 2018 --> Mar 2018 | Trial primary completion date: Feb 2018 --> Mar 2018 Not yet recruiting --> Recruiting
- ||| BI 1265162 / Boehringer Ingelheim
New P1 trial: This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men (clinicaltrials.gov) - Nov 21, 2017
P1, N=56, Not yet recruiting, Sponsor: Boehringer Ingelheim