Drugs / Solanezumab
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02614131 | Dec 2015 → Dec 2016 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01148498 | Aug 2010 → Aug 2012 | Alzheimer disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00749216 | Sep 2008 → Jul 2009 | Alzheimer disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00329082 | May 2006 → May 2008 | Alzheimer disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04623242 | Dec 2012 → Nov 2019 | familial Alzheimer disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2/3 | NCT01760005 | Dec 2012 → Apr 2028 expected | familial Alzheimer disease | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 36 trials · 4 missed | ||||||
| Phase 3 | NCT02760602 | Jun 2016 → May 2017 | Alzheimer disease | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT02008357 | Feb 2014 → Dec 2022 | cognitive disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT01900665 | Jul 2013 → Oct 2016 | Alzheimer disease | Eli Lilly and Company | Terminated | Missed primary |
| Phase 3 | NCT01127633 | Dec 2010 → Jul 2014 | Alzheimer disease | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT00904683 | May 2009 → Jun 2012 | Alzheimer disease | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00905372 | May 2009 → Apr 2012 | Alzheimer disease | Eli Lilly and Company | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2023-03-08 | Eli Lilly and Company | Results Lilly Provides Update on A4 Study of Solanezumab for Preclinical Alzheimer's Disease lilly.com ↗
Results of the A4 Study clearly showed that the primary and secondary endpoints were not met. |
| 2020-02-10 | Eli Lilly and Company | Results Lilly Announces Topline Results for Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study lilly.com ↗
INDIANAPOLIS, Feb. 10, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the analysis performed by Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study showed that solanezumab did not meet the primary endpoint. |
| 2016-12-08 | Eli Lilly and Company | Results Lilly Announces Detailed Results of Solanezumab Phase 3 EXPEDITION3 Study at the Clinical Trials on Alzheimer's Disease (CTAD) 2016 Meeting lilly.com ↗
Eli Lilly and Company (NYSE:LLY) today presented detailed results of its phase 3 EXPEDITION3 trial at the 9th Clinical Trials on Alzheimer's Disease (CTAD) meeting. |
| 2016-11-23 | Eli Lilly and Company | Results Lilly Announces Top-Line Results of Solanezumab Phase 3 Clinical Trial lilly.com ↗
Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=.095), as measured by the ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive subscale). |
| 2015-07-22 | Eli Lilly and Company | Results Data Using New Delayed-Start Methodology Suggested Benefit of Early Treatment with Solanezumab in Patients with Mild Alzheimer's Disease lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced results suggesting the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. |
| 2012-10-08 | Eli Lilly and Company | Results Lilly Announces Detailed Results of the Phase 3 Solanezumab EXPEDITION Studies Following a Presentation of the Independent Analyses by the Alzheimer's Disease Cooperative Study (ADCS) lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced its detailed results for the Phase 3, double-blind, placebo-controlled EXPEDITION studies in patients with mild-to-moderate Alzheimer's disease. |
| 2012-08-24 | Eli Lilly and Company | Results Eli Lilly and Company Announces Top-Line Results on Solanezumab Phase 3 Clinical Trials in Patients with Alzheimer's Disease lilly.com ↗ |
| 2008-07-30 | Eli Lilly and Company | Results Phase II Data on Lilly's Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimer's Disease lilly.com ↗
In this study, intravenously administered LY2062430 bound to the amyloid beta protein, resulting in increased amounts of amyloid beta in participants' blood and cerebrospinal fluid. |
All press releases naming this drug 10 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Solanezumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01760005 ↗ |
| Known as | LY2062430 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00329082 ↗ |
| Modality | Monoclonal antibody | “LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody” NCT00904683 ↗ |
| Route | Intravenous | “100mg QW IV for 12 weeks” NCT00329082 ↗ |
| Target | APP | “Amyloid-beta A4 protein binding agent” CHEMBL1743072 ↗ |