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32 News |  |
- | Journal: Pharmacological Inventions for Alzheimer Treatment in the United States of America: A Revision Patent from 2010 - 2020. (Pubmed Central) - Jan 16, 2023
CPC-201 and PXT864 demonstrated, in Phase 2, good tolerability and improvement of AD symptoms...The most advanced treatments in their research are those focused on treating Aβ accumulation. More studies are needed to prove the efficacy of the patented molecules.
- || LY3202626 / Eli Lilly
PK/PD data, Journal: Robust Pharmacodynamic Effect of LY3202626, a Central Nervous System Penetrant, Low Dose BACE1 Inhibitor, in Humans and Nonclinical Species. (Pubmed Central) - Mar 5, 2022
LY3202626 is a potent BACE1 inhibitor with high blood-brain barrier permeability. The favorable safety and pharmacokinetic/pharmacodynamic profile of LY3202626 supports further clinical development.
- |||| Kisunla (donanemab-azbt) / Eli Lilly
Trial completion: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) (clinicaltrials.gov) - Feb 15, 2022
P2, N=272, Completed, Sponsor: Eli Lilly and Company
The favorable safety and pharmacokinetic/pharmacodynamic profile of LY3202626 supports further clinical development. Active, not recruiting --> Completed
- | LY3202626 / Eli Lilly
Journal: Excretion, Mass balance and Metabolism of [C] LY3202626 in Humans: An interplay of microbial reduction, reabsorption, and AO oxidation that leads to an extended excretion profile. (Pubmed Central) - Sep 15, 2021
A portion of plasma radioactivity was unextractable and presumably bound covalently to plasma proteins. In vitro incubation of LY3202626 in human liver microsomes in the presence of NADPH with dimedone as a trapping agent implicated the formation of the proposed sulfenic acid intermediate.
- || LY3202626 / Eli Lilly
Clinical, Journal: Discovery and Early Clinical Development of LY3202626, a Low-Dose, CNS-Penetrant BACE Inhibitor. (Pubmed Central) - Aug 25, 2021
LY2886721 advanced to Phase II, but development was halted due to abnormally elevated liver enzymes. Herein, we report the discovery and clinical development of LY3202626, a highly potent, CNS-penetrant, and low-dose BACE inhibitor, which successfully addressed these key development challenges.
- || LY3202626 / Eli Lilly
Clinical, P2 data, Journal: Phase II (NAVIGATE-AD study) Results of LY3202626 Effects on Patients with Mild Alzheimer's Disease Dementia. (Pubmed Central) - Jun 12, 2021
LY3202626 tested at doses generating 70-90% BACE inhibition was generally well tolerated in this study. LY3202626 treatment did not result in a clinically significant change in cerebral tau burden as measured by flortaucipir nor in change of functional or cognitive decline compared to placebo.
- || LY3202626 / Eli Lilly
Enrollment change: A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease (clinicaltrials.gov) - Apr 19, 2021
P1, N=94, Completed, Sponsor: Eli Lilly and Company
LY3202626 treatment did not result in a clinically significant change in cerebral tau burden as measured by flortaucipir nor in change of functional or cognitive decline compared to placebo. N=136 --> 94
- | Kisunla (donanemab-azbt) / Eli Lilly
Enrollment closed: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) (clinicaltrials.gov) - Aug 4, 2019
P2, N=266, Active, not recruiting, Sponsor: Eli Lilly and Company
N=136 --> 94 Recruiting --> Active, not recruiting
- | Kisunla (donanemab-azbt) / Eli Lilly
Trial completion date, Trial primary completion date: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) (clinicaltrials.gov) - Aug 15, 2018
P2, N=375, Recruiting, Sponsor: Eli Lilly and Company
Recruiting --> Active, not recruiting Trial completion date: Dec 2020 --> Sep 2021 | Trial primary completion date: Mar 2020 --> Oct 2020
- | LY3202626 / Eli Lilly
Trial termination, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Aug 6, 2018
P2, N=316, Terminated, Sponsor: Eli Lilly and Company
Trial completion date: Dec 2020 --> Sep 2021 | Trial primary completion date: Mar 2020 --> Oct 2020 Active, not recruiting --> Terminated; Low likelihood of identifying a statistically significant treatment effect.
- ||| LY3202626 / Eli Lilly
Enrollment closed, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Apr 12, 2018
P2, N=380, Active, not recruiting, Sponsor: Eli Lilly and Company
Active, not recruiting --> Terminated; Low likelihood of identifying a statistically significant treatment effect. Recruiting --> Active, not recruiting
- || LY3202626 / Eli Lilly
Trial completion date, Trial primary completion date, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Apr 11, 2018
P2, N=380, Recruiting, Sponsor: Eli Lilly and Company
Recruiting --> Active, not recruiting Trial completion date: Jun 2019 --> Jul 2018 | Trial primary completion date: Jun 2019 --> Jul 2018
- |||| Kisunla (donanemab-azbt) / Eli Lilly
Enrollment open: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) (clinicaltrials.gov) - Dec 27, 2017
P2, N=375, Recruiting, Sponsor: Eli Lilly and Company
Trial completion date: Jun 2019 --> Jul 2018 | Trial primary completion date: Jun 2019 --> Jul 2018 Not yet recruiting --> Recruiting
- ||||| Kisunla (donanemab-azbt) / Eli Lilly
New P2 trial: A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) (clinicaltrials.gov) - Dec 7, 2017
P2, N=375, Not yet recruiting, Sponsor: Eli Lilly and Company
- ||| LY3202626 / Eli Lilly
Enrollment change, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Aug 15, 2017
P2, N=380, Recruiting, Sponsor: Eli Lilly and Company
Not yet recruiting --> Recruiting N=500 --> 380
- | LY3202626 / Eli Lilly
Trial completion: A Study of LY3202626 in Healthy Participants (clinicaltrials.gov) - Jun 20, 2017
P1, N=30, Completed, Sponsor: Eli Lilly and Company
N=500 --> 380 Recruiting --> Completed
- || LY3202626 / Eli Lilly
Trial primary completion date, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Jun 14, 2017
P2, N=500, Recruiting, Sponsor: Eli Lilly and Company
Recruiting --> Completed Trial primary completion date: Dec 2019 --> Aug 2019
- || LY3202626 / Eli Lilly
Trial primary completion date, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - May 3, 2017
P2, N=500, Recruiting, Sponsor: Eli Lilly and Company
Trial primary completion date: Dec 2019 --> Aug 2019 Trial primary completion date: May 2019 --> Dec 2019
- || LY3202626 / Eli Lilly
Trial primary completion date, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Feb 1, 2017
P2, N=500, Recruiting, Sponsor: Eli Lilly and Company
Trial primary completion date: May 2019 --> Dec 2019 Trial primary completion date: Aug 2018 --> May 2019
- | LY3202626 / Eli Lilly
New P1 trial: A Study of LY3202626 in Healthy Participants (clinicaltrials.gov) - Jan 18, 2017
P1, N=30, Not yet recruiting, Sponsor: Eli Lilly and Company
- |||| LY3202626 / Eli Lilly
Enrollment open, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Jul 6, 2016
P2, N=500, Recruiting, Sponsor: Eli Lilly and Company
Trial primary completion date: Aug 2018 --> May 2019 Not yet recruiting --> Recruiting
- ||||| LY3202626 / Eli Lilly
New P2 trial, Tau PET: NAVIGATE-AD: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) - Jun 9, 2016
P2, N=500, Not yet recruiting, Sponsor: Eli Lilly and Company
- ||| LY3202626 / Eli Lilly
Trial completion, Enrollment change: A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease (clinicaltrials.gov) - Feb 26, 2016
P1, N=136, Completed, Sponsor: Eli Lilly and Company
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | N=100 --> 136
- || LY3202626 / Eli Lilly
Enrollment closed: A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease (clinicaltrials.gov) - Jan 11, 2016
P1, N=100, Active, not recruiting, Sponsor: Eli Lilly and Company
Active, not recruiting --> Completed | N=100 --> 136 Recruiting --> Active, not recruiting
- LY3202626 / Eli Lilly
Trial completion: A Study of [ (clinicaltrials.gov) - Dec 16, 2015
P1, N=8, Completed, Sponsor: Eli Lilly and Company
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- LY3202626 / Eli Lilly
Enrollment closed: A Study of [ (clinicaltrials.gov) - Nov 24, 2015
P1, N=8, Active, not recruiting, Sponsor: Eli Lilly and Company
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- LY3202626 / Eli Lilly
Enrollment open: A Study of [ (clinicaltrials.gov) - Oct 22, 2015
P1, N=8, Recruiting, Sponsor: Eli Lilly and Company
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- LY3202626 / Eli Lilly
New P1 trial: A Study of [ (clinicaltrials.gov) - Sep 21, 2015
P1, N=8, Not yet recruiting, Sponsor: Eli Lilly and Company
- ||| LY3202626 / Eli Lilly
New P1 trial: A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease (clinicaltrials.gov) - Dec 23, 2014
P1, N=100, Recruiting, Sponsor: Eli Lilly and Company