Teplizumab

Summary

Teplizumab (CHEMBL1743078) is an approved antibody (ATC A10XX01) targeting CD3E; indicated across 3 conditions including type 1 diabetes mellitus and glucose intolerance.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: A10XX01
• Targets: 1 (CD3E)
• Indications: 3 conditions
• Clinical trials: 19

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1743078
Name	Teplizumab
Type	Antibody
Max phase	4
ATC	A10XX01

Also known as: HUMANIZED OKT3, Humanzied OKT3, MGA-031, MGA031, PRV-031, PRV031, Teplizumab, Teplizumab mzwv, Teplizumab-mzwv, Tzield, hOKT3 gamma 1 (Ala-Ala), TEPLIZUMAB

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

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
type 1 diabetes mellitus	4	MONDO:0005147	MONDO:0005147

2 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
glucose intolerance	2	MONDO:0001076	EFO:0002546
psoriasis	1	MONDO:0005083	EFO:0000676

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
Not specified	6
PHASE2	5
PHASE3	3
PHASE1/PHASE2	2
PHASE4	1
PHASE2/PHASE3	1
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05757713	PHASE4	ACTIVE_NOT_RECRUITING	Teplizumab in Pediatric Stage 2 Type 1 Diabetes
NCT07088068	PHASE3	RECRUITING	A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
NCT00385697	PHASE2/PHASE3	COMPLETED	The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
NCT00920582	PHASE3	TERMINATED	Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
NCT03875729	PHASE3	COMPLETED	Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
NCT06791291	PHASE2	RECRUITING	Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
NCT07216391	PHASE2	NOT_YET_RECRUITING	Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
NCT00378508	PHASE2	COMPLETED	Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
NCT00954915	PHASE1/PHASE2	TERMINATED	Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis
NCT01030861	PHASE2	COMPLETED	Teplizumab for Prevention of Type 1 Diabetes In Relatives At-Risk
NCT03751007	PHASE1/PHASE2	COMPLETED	A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)
NCT04270942	PHASE2	COMPLETED	At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
NCT07610213	PHASE1	NOT_YET_RECRUITING	Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes
NCT04598893	Not specified	ACTIVE_NOT_RECRUITING	Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
NCT06481904	Not specified	RECRUITING	Registry for Stage 2 Type 1 Diabetes
NCT07260110	Not specified	RECRUITING	A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
NCT07360080	Not specified	RECRUITING	Long-Term Outcomes of Teplizumab in Routine Clinical Care
NCT07457580	Not specified	RECRUITING	Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
NCT06892002	Not specified	COMPLETED	Description of Patients With Type 1 Diabetes Treated With Teplizumab

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).