Ligelizumab

Summary

Ligelizumab (CHEMBL2109457) is a phase-3 clinical-stage antibody targeting IGHE; indicated across 8 conditions including allergic disease and food allergy.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (IGHE)
• Indications: 8 conditions
• Clinical trials: 20

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2109457
Name	Ligelizumab
Type	Antibody
Max phase	3

Also known as: Ligelizumab, QGE-031, QGE031, LIGELIZUMAB

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
IGHE	immunoglobulin heavy constant epsilon	Binding	11.83		P01854

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): IGHE.

Top Reactome pathways

6 total, by targets touching each:

Pathway	Targets	Genes
Fc epsilon receptor (FCERI) signaling	1	IGHE
Role of LAT2/NTAL/LAB on calcium mobilization	1	IGHE
FCERI mediated MAPK activation	1	IGHE
FCERI mediated Ca+2 mobilization	1	IGHE
FCERI mediated NF-kB activation	1	IGHE
Interleukin-4 and Interleukin-13 signaling	1	IGHE

Dominant GO biological processes

GO term	Targets
antibody-dependent cellular cytotoxicity	1
adaptive immune response	1
B cell antigen processing and presentation	1
inflammatory response	1
immune response	1
complement activation, classical pathway	1
type I hypersensitivity	1
antibacterial humoral response	1
macrophage differentiation	1
type 2 immune response	1
B cell proliferation	1
B cell activation	1
macrophage activation	1
mast cell degranulation	1
eosinophil degranulation	1

Indications & clinical

Indications

6 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
allergic disease	3	MONDO:0005271	MONDO:0005271
food allergy	3	MONDO:0700226	EFO:1001890
atopic eczema	2	MONDO:0004980	EFO:0000274
bullous pemphigoid	2	MONDO:0019082	EFO:0007187
asthma	2	MONDO:0004979	MONDO:0004979
cold urticaria	1	MONDO:0022799	EFO:1001881

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

Clinical trials

Total trials: 20.

Phase distribution

Phase	Trials
PHASE2	9
PHASE3	7
PHASE1	2
PHASE1/PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03580356	PHASE3	COMPLETED	A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
NCT03580369	PHASE3	COMPLETED	A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
NCT03907878	PHASE3	COMPLETED	A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines
NCT04210843	PHASE3	TERMINATED	Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
NCT04984876	PHASE3	TERMINATED	Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
NCT05024058	PHASE3	TERMINATED	Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
NCT05678959	PHASE3	TERMINATED	Long-term Extension Study of Ligelizumab in Food Allergy
NCT01451450	PHASE2	WITHDRAWN	Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
NCT01552629	PHASE2	COMPLETED	A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients
NCT01688882	PHASE2	TERMINATED	Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
NCT01703312	PHASE1/PHASE2	COMPLETED	A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
NCT01716754	PHASE2	COMPLETED	Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
NCT02075008	PHASE2	TERMINATED	Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
NCT02336425	PHASE2	TERMINATED	Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
NCT02477332	PHASE2	COMPLETED	Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
NCT02649218	PHASE2	COMPLETED	A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
NCT03437278	PHASE2	COMPLETED	Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)
NCT01596712	PHASE1	COMPLETED	Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects
NCT04513548	PHASE1	TERMINATED	Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
NCT04903613	Not specified	NO_LONGER_AVAILABLE	Global Managed Access Program Cohort for Ligelizumab in CSU

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).