Omalizumab

Summary

Omalizumab (CHEMBL1201589) is an approved antibody (ATC R03DX05) targeting IGHE; indicated across 29 conditions including urticaria and obstructive lung disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: R03DX05
• Targets: 1 (IGHE)
• Indications: 29 conditions
• Clinical trials: 192

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201589
Name	Omalizumab
Type	Antibody
Max phase	4
ATC	R03DX05

Also known as: Ct-p39, CT-P39, CTP-39, CTP39, GBR 310, Gbr-310, Hs632, IGE25, OLIZUMAB, Omalizumab, Omalizumab biosimilar (ct-p39), Omalizumab biosimilar - synermore

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	7.83		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

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

Indication	Phase	MONDO	EFO
urticaria	4	MONDO:0005492	EFO:0005531
obstructive lung disease	4	MONDO:0002267	HP:0006536
asthma	4	MONDO:0004979	MONDO:0004979
rhinitis	4	MONDO:0003014	EFO:0008521

21 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
sinusitis	3	MONDO:0005961	EFO:0007486
seasonal allergic rhinitis	3	MONDO:0005324	EFO:0003956
allergic rhinitis	3	MONDO:0011786	EFO:0005854
angioedema	3	MONDO:0010481	EFO:0005532
interstitial cystitis	3	MONDO:0018301	EFO:0008507
chronic obstructive pulmonary disease	2	MONDO:0005002	EFO:0000341
eosinophilic esophagitis	2	MONDO:0005361	EFO:0004232
immune system disorder	2	MONDO:0005046	EFO:0000540
bullous pemphigoid	2	MONDO:0019082	EFO:0007187
gastroenteritis	2	MONDO:0002269	EFO:1001463
food allergy	2	MONDO:0700226	EFO:1001890
bronchitis	2	MONDO:0003781	EFO:0009661
interstitial nephritis	2	MONDO:0001085	MONDO:0001085
severe acute respiratory syndrome	2	MONDO:0005091	MONDO:0100096
allergic disease	2	MONDO:0005271	MONDO:0005271
familial dermatographia	2	MONDO:0007448	EFO:1000685
cold urticaria	2	MONDO:0022799	EFO:1001881
atopic eczema	1	MONDO:0004980	EFO:0000274
drug allergy	1	MONDO:0000775	EFO:0009482
colonic neoplasm	1	MONDO:0005401	MONDO:0021063
systemic lupus erythematosus	1	MONDO:0007915	MONDO:0007915

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

Clinical trials

Total trials: 192.

Phase distribution

Phase	Trials
PHASE4	52
PHASE2	43
PHASE3	39
Not specified	25
PHASE1	20
PHASE2/PHASE3	5
PHASE1/PHASE2	5
EARLY_PHASE1	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04774315	PHASE4	ACTIVE_NOT_RECRUITING	Molecular Endotypes of Chronic Idiopathic Urticaria
NCT06027073	PHASE4	NOT_YET_RECRUITING	Biologics and Sublingual Immunotherapy
NCT06437171	PHASE4	ACTIVE_NOT_RECRUITING	FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA
NCT06618963	PHASE4	RECRUITING	Effect of Omalizumab in the Skin of Food Allergy Patients
NCT00096954	PHASE4	COMPLETED	A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
NCT00133042	PHASE4	COMPLETED	The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma
NCT00139152	PHASE4	COMPLETED	Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
NCT00208234	PHASE4	UNKNOWN	Effect of Xolair on Airway Hyperresponsiveness
NCT00242359	PHASE4	WITHDRAWN	A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
NCT00264849	PHASE4	COMPLETED	Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
NCT00267202	PHASE4	COMPLETED	Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
NCT00329381	PHASE4	COMPLETED	Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
NCT00367016	PHASE4	COMPLETED	Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)
NCT00377572	PHASE4	COMPLETED	Inner-City Anti-IgE Therapy for Asthma
NCT00454051	PHASE4	COMPLETED	Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
NCT00472030	PHASE4	COMPLETED	Efficacy and Safety of Omalizumab in Bullous Pemphigoid
NCT00495612	PHASE4	COMPLETED	A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
NCT00546143	PHASE4	COMPLETED	Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma
NCT00555971	PHASE4	COMPLETED	Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
NCT00567476	PHASE4	COMPLETED	Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
NCT00603785	PHASE4	WITHDRAWN	Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis
NCT00624832	PHASE4	COMPLETED	A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
NCT00639691	PHASE4	COMPLETED	A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
NCT00657891	PHASE4	COMPLETED	The Effect of Xolair (Omalizumab) on Allergy Blood Cells
NCT00673218	PHASE4	UNKNOWN	The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
NCT00691873	PHASE4	COMPLETED	Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
NCT00784485	PHASE4	TERMINATED	Non-invasive Measures of Effects of Xolair in Asthma
NCT00787917	PHASE4	TERMINATED	An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
NCT00822783	PHASE4	COMPLETED	Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients
NCT00870584	PHASE4	COMPLETED	Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
NCT01125748	PHASE4	COMPLETED	A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
NCT01430403	PHASE4	COMPLETED	Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
NCT01584687	PHASE4	UNKNOWN	mRNA Expression as a Biomarker of Omalizumab Response
NCT01701583	PHASE4	COMPLETED	Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
NCT01912872	PHASE4	TERMINATED	Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
NCT01922037	PHASE4	COMPLETED	A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
NCT02023151	PHASE4	COMPLETED	Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
NCT02300701	PHASE4	COMPLETED	Role of Anti-IgE in Severe Childhood Eczema
NCT02392624	PHASE4	COMPLETED	A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
NCT02550106	PHASE4	COMPLETED	Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
NCT02654145	PHASE4	COMPLETED	Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients
NCT02658877	PHASE4	TERMINATED	Sputum-derived Cellular Targets After Xolair (Omalizumab)
NCT02742805	PHASE4	WITHDRAWN	Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
NCT02966314	PHASE4	COMPLETED	Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
NCT03111628	PHASE4	COMPLETED	Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
NCT03964051	PHASE4	TERMINATED	Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
NCT04037176	PHASE4	COMPLETED	Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)
NCT04195958	PHASE4	TERMINATED	A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
NCT04585997	PHASE4	UNKNOWN	Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - Choosebetweenamab.
NCT04998604	PHASE4	COMPLETED	EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
NCT05405478	PHASE4	UNKNOWN	Omalizumab Efficacy in Patients With Refractory Nasal Polyps
NCT06806826	PHASE4	COMPLETED	The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study
NCT06042478	PHASE3	ACTIVE_NOT_RECRUITING	Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
NCT06365879	PHASE3	ACTIVE_NOT_RECRUITING	To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria
NCT00046748	PHASE3	COMPLETED	Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
NCT00079937	PHASE3	COMPLETED	Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
NCT00109187	PHASE3	COMPLETED	An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
NCT00109200	PHASE3	COMPLETED	A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma
NCT00180011	PHASE2/PHASE3	COMPLETED	Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
NCT00219323	PHASE3	COMPLETED	Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.
NCT00232050	PHASE3	COMPLETED	Study of Omalizumab in Moderate to Severe Bronchial Asthma
NCT00314574	PHASE3	COMPLETED	A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)
NCT00396409	PHASE3	COMPLETED	Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
NCT00401596	PHASE3	COMPLETED	A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
NCT00482248	PHASE3	COMPLETED	Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
NCT00482508	PHASE3	COMPLETED	Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
NCT00500539	PHASE3	COMPLETED	Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
NCT00829179	PHASE3	COMPLETED	Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
NCT01007149	PHASE3	COMPLETED	Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
NCT01113437	PHASE2/PHASE3	UNKNOWN	Omalizumab in Non-atopic Asthma
NCT01155700	PHASE3	COMPLETED	Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
NCT01202903	PHASE3	COMPLETED	Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
NCT01264939	PHASE3	COMPLETED	A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
NCT01287117	PHASE3	COMPLETED	A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
NCT01292473	PHASE3	COMPLETED	A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
NCT01294878	PHASE3	COMPLETED	Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome
NCT01328886	PHASE3	COMPLETED	Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children
NCT01723072	PHASE3	COMPLETED	Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
NCT01803763	PHASE2/PHASE3	COMPLETED	Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
NCT01976208	PHASE2/PHASE3	COMPLETED	Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
NCT02049294	PHASE2/PHASE3	COMPLETED	Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
NCT02161562	PHASE3	COMPLETED	OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
NCT02329223	PHASE3	COMPLETED	Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
NCT03280537	PHASE3	COMPLETED	A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
NCT03280550	PHASE3	COMPLETED	A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
NCT03328897	PHASE3	COMPLETED	Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
NCT03369704	PHASE3	COMPLETED	Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
NCT03478930	PHASE3	COMPLETED	An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
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
NCT03881696	PHASE3	COMPLETED	Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
NCT04426890	PHASE3	COMPLETED	To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
NCT04944602	PHASE3	UNKNOWN	Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria
NCT05390255	PHASE3	UNKNOWN	Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis
NCT05774639	PHASE3	COMPLETED	Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
NCT05813470	PHASE3	COMPLETED	Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
NCT02570984	PHASE2	ACTIVE_NOT_RECRUITING	Preventing Asthma in High Risk Kids
NCT04045301	PHASE2	ACTIVE_NOT_RECRUITING	Omalizumab to Accelerate a Symptom-driven Multi-food OIT
NCT05332067	PHASE2	RECRUITING	Omalizumab Before Onset of Exacerbations
NCT06438757	PHASE2	ACTIVE_NOT_RECRUITING	Trial of JYB1904 in Patients With Allergic Asthma

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).