Otelixizumab

Summary

Otelixizumab (CHEMBL1743053) is a phase-3 clinical-stage antibody targeting CD3E; indicated across 3 conditions including type 1 diabetes mellitus and rheumatoid arthritis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (CD3E)
• Indications: 3 conditions
• Clinical trials: 8

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1743053
Name	Otelixizumab
Type	Antibody
Max phase	3

Also known as: CHAGLY CD3, CHAGLYCD-3, ChAglyCD, Chaglycd3, Otelixizumab, TRX-4, TRX4, OTELIXIZUMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
CD3E	CD3e	Binding		0%	P07766

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): CD3E.

Top Reactome pathways

10 total, by targets touching each:

Pathway	Targets	Genes
Adaptive Immune System	1	CD3E
Immune System	1	CD3E
Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell	1	CD3E
TCR signaling	1	CD3E
Downstream TCR signaling	1	CD3E
Phosphorylation of CD3 and TCR zeta chains	1	CD3E
Translocation of ZAP-70 to Immunological synapse	1	CD3E
Generation of second messenger molecules	1	CD3E
Regulation of T cell activation by CD28 family	1	CD3E
Co-inhibition by PD-1	1	CD3E

Dominant GO biological processes

GO term	Targets
positive regulation of cell-matrix adhesion	1
adaptive immune response	1
positive regulation of T cell anergy	1
T cell anergy	1
cell surface receptor signaling pathway	1
cell surface receptor protein tyrosine kinase signaling pathway	1
signal complex assembly	1
G protein-coupled receptor signaling pathway	1
smoothened signaling pathway	1
positive regulation of gene expression	1
negative regulation of gene expression	1
dendrite development	1
calcium-mediated signaling	1
cerebellum development	1
T cell costimulation	1

Indications & clinical

Indications

3 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
type 1 diabetes mellitus	3	MONDO:0005147	MONDO:0005147
rheumatoid arthritis	1	MONDO:0008383	EFO:0000685

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 8.

Phase distribution

Phase	Trials
PHASE2	4
PHASE1	2
PHASE3	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01123083	PHASE3	COMPLETED	Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
NCT00451321	PHASE2	TERMINATED	TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
NCT00627146	PHASE2	COMPLETED	Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients
NCT01114503	PHASE2	TERMINATED	A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease
NCT01222078	PHASE2	TERMINATED	Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus
NCT02000817	PHASE1/PHASE2	COMPLETED	Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
NCT00946257	PHASE1	COMPLETED	Subcutaneous Administration of Otelixizumab to T1DM Patients
NCT01077531	PHASE1	TERMINATED	Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).