Drugs / Otelixizumab
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01101555 | May 2010 → Sep 2011 | rheumatoid arthritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00946257 | Jul 2009 → Aug 2011 | type 1 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02000817 | Mar 2014 → Sep 2018 | type 1 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01222078 | Nov 2010 → May 2011 | type 1 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT01114503 | Jul 2010 → Aug 2012 | disease of orbital part of eye adnexa | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00451321 | Jul 2006 → Dec 2011 | type 1 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT01123083 | May 2010 → Mar 2012 | type 1 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00678886 | Jul 2008 → Jan 2012 | type 1 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01077531 Comparator | Apr 2010 → Mar 2013 | rheumatoid arthritis | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00627146 Comparator | Jun 2000 → Mar 2007 | type 1 diabetes mellitus | University Hospital Brussels | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-03-05 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Podium Presentation at AD/PD of Nasal Anti-CD3 in Alzheimer’s Disease tizianalifesciences.com ↗
Data shows reduction of microglia activation and improvement in behavior in rodent models of Alzheimer’s disease (AD) and Parkinson’s disease (PD) |
| 2023-03-31 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Anti-CD3 mAb Research for the Treatment of Alzheimer’s Disease to be Presented by Dr. Howard Weiner at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders Conference tizianalifesciences.com ↗
Data shows reduction of microglia activation and improvement in behavior in rodent model of Alzheimer’s disease (AD) |
| 2011-03-11 | GlaxoSmithKline | Results GlaxoSmithKline and Tolerx announce phase III DEFEND-1 study of otelixizumab in type 1 diabetes did not meet its primary endpoint gsk.com ↗
Issued: London UK and Cambridge, Mass, US GlaxoSmithKline (GSK) and Tolerx, Inc. today announced that the Phase III DEFEND-1 study of otelixizumab, an investigational humanised anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes. |
| 1996-09-01 | 7 Hills Pharma, LLC | Results Alpha 4 beta 1 (CD49d/CD29) integrin costimulation of human T cells enhances transcription factor and cytokine induction in the absence of altered sensitivity to anti-CD3 stimulation 7hillspharma.com ↗
In contrast to freshly isolated T cells, in vitro-cultured T cells did not require costimulation for cytokine secretion in response to anti-CD3 alone. |
All press releases naming this drug 4 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Otelixizumab | “Otelixizumab is a humanized, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody” NCT01101555 ↗ |
| Known as | ChAglyCD | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743053 ↗ |
| Known as | ChAglyCD3 | “The aim of the study was to examine the 48 month outcome of treating recent-onset type 1 diabetic patients for 6 days with humanised CD3-antibody, ChAglyCD3.” PMID 20225393 ↗ Jan 2010 |
| Known as | GSK2136525 | “Otelixizumab (GSK2136525) is a humanised, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb).” NCT01077531 ↗ |
| Known as | TRX-4 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743053 ↗ |
| Modality | Monoclonal antibody | “ChAgly CD3) Monoclonal Antibody” NCT00627146 ↗ |
| Route | Intravenous | “6 days treatment 8mg/d intravenous” NCT00627146 ↗ |
| Target | CD3E | “CD3ɛ target engagement” PMID 30566758 ↗ Feb 2019 |