Xolair

(omalizumab)

ApprovedMonoclonal antibody

Omalizumab is used to treat moderate to severe allergic asthma and chronic hives by blocking a substance in the body that causes allergic reactions and inflammation.[2] Xolair is currently approved and in use across 7 indications[4].[1]

Xolair is one of 104 biologic programs targeting Allergic Disease. It is currently in Approved.

Indications

167

Total Trials

Active Trials

103

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Allergic DiseaseRecruiting

RhinitisUnknown

Allergic RhinitisActive, not recruiting

Chronic Idiopathic UrticariaCompleted

Physical ActivityTerminated

Cystic FibrosisTerminated

OmalizumabUnknown status

Allergic DiseasePhase 3

Recruiting

RhinitisPreclinical

Unknown

Allergic RhinitisPreclinical

Active, not recruiting

Chronic Idiopathic UrticariaApproved

Completed

Physical ActivityApproved

Terminated

Cystic FibrosisApproved

Terminated

OmalizumabApproved

Unknown status

Competition

Competitive Landscape

107 competitors in Cystic Fibrosis

#DrugCompanyPhaseTrials

Xolair

Roche

Approved

1 2

Ibsrela

AArdelyx

Phase 3

1 3

Biaxin

AbbVie

Phase 2

2 4

Lamprene

Novartis

Phase 2

1 5

HSK31858

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

2 6

Tygacil

PPrism Pharmaceuticals

Phase 2

1 7

ELX/TEZ/IVA

Vertex Pharmaceuticals

Phase 3

18 8

Trikafta

NNottingham University Hospitals NHS Trust

Phase 3

4 9

VNZ/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

1 10

VX-121/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Chronic Rhinosinusitis

NCT06683261

Post-ApprovalRecruiting

Food Allergy

NCT06618963

Post-ApprovalActive, not recruiting

Treatment

NCT06437171

Phase 1Recruiting

Study completion

NCT07356713

Q3 2027

Phase 3Active, not recruiting

Chronic Spontaneous Urticaria

NCT06042478

Q4 2027

Phase 2Recruiting

Food Allergy

NCT06934200

Clinical

Trials by Indication[1]

Asthma25 trials

Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus

Completed·UUniversity of Virginia·Phase 2·NCT02388997·31 enrolled

Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

Completed· Novartis logo

Novartis·Phase 3·NCT00046748·484 enrolled

Preventing Asthma in High Risk Kids

Active, not recruiting·—·Phase 2·NCT02570984·200 enrolled

Show 22 more trials

Soluble CD23 Expression in Asthma Patients Treated With OMA

Terminated·UUniversity of Mississippi Medical Center·N/A·NCT00226200·80 enrolled

Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study.

Completed·RRigshospitalet, Denmark·Phase 2·NCT03727971·66 enrolled

A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)

Completed· Roche logo

Roche·Phase 3·NCT00314574·850 enrolled

Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Completed· GSK logo

GSK·Phase 4·NCT02654145·145 enrolled

Inner-City Anti-IgE Therapy for Asthma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00377572·419 enrolled

Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)

Completed·UUniversity of California, Davis·Phase 4·NCT00367016·6 enrolled

Unknown status·—··NCT04665141·600 enrolled

Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

Active, not recruiting·QQianfoshan Hospital··NCT06771934·60 enrolled

Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

Completed·—·Phase 2/3·NCT00180011·18 enrolled

Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

Completed· Novartis logo

Novartis·Phase 4·NCT00546143·32 enrolled

ICATA Asthma Mechanistic Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00377390·224 enrolled

The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma

Completed·UUniversity of Florida·Phase 4·NCT00133042·16 enrolled

Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma

Terminated· Novartis logo

Novartis·Phase 4·NCT01912872·112 enrolled

A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Withdrawn·—·Phase 4·NCT00242359

A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma

Completed· Roche logo

Roche·Phase 4·NCT00495612·69 enrolled

A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Completed· Roche logo

Roche·Phase 4·NCT01922037·806 enrolled

Study of Omalizumab in Moderate to Severe Bronchial Asthma

Completed· Novartis logo

Novartis·Phase 3·NCT00232050·327 enrolled

Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00482508·95 enrolled

Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

Completed· Novartis logo

Novartis·Phase 3·NCT00219323·133 enrolled

Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

Completed· Novartis logo

Novartis·Phase 2·NCT01716754·471 enrolled

Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

Completed· Novartis logo

Novartis·Phase 3·NCT01007149·79 enrolled

Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".

Unknown status·UUniversity of Newcastle, Australia·Phase 4·NCT04585997·200 enrolled

Allergic Asthma20 trials

Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab

Terminated·UUniversity of North Carolina, Chapel Hill·N/A·NCT00287378·1 enrolled

A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma

Completed· Novartis logo

Novartis·Phase 1/2·NCT01703312·37 enrolled

Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT01202903·616 enrolled

Show 17 more trials

Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma

Completed·CCinnagen·Phase 3·NCT05813470·256 enrolled

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

Completed· Novartis logo

Novartis·Phase 4·NCT00639691·48 enrolled

Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

Completed· Novartis logo

Novartis·Phase 4·NCT00670930·36 enrolled

Trial of JYB1904 in Patients With Allergic Asthma

Active, not recruiting·JJemincare·Phase 2·NCT06438757·69 enrolled

Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients

Recruiting·LLongbio Pharma·Phase 2·NCT07342803·200 enrolled

Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

Completed· Novartis logo

Novartis·Phase 4·NCT00567476·116 enrolled

Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

Completed· Novartis logo

Novartis·Phase 3·NCT00079937·628 enrolled

Effect of Anti-IgE in Non-Allergic Asthma

Terminated·JJohns Hopkins University·Phase 2·NCT00162773·29 enrolled

Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis

Completed· Novartis logo

Novartis·Phase 3·NCT00396409·128 enrolled

Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Completed· Novartis logo

Novartis·Phase 4·NCT00870584·271 enrolled

XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States

Completed· Novartis logo

Novartis··NCT05157087·16,246 enrolled

Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

Completed·SShanghai Zhangjiang Biotechnology Limited Company·Phase 2/3·NCT01976208·630 enrolled

Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma

Completed· Novartis logo

Novartis·Phase 4·NCT00267202·275 enrolled

Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma

Completed· Novartis logo

Novartis·Phase 4·NCT00454051·31 enrolled

Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

Completed· Novartis logo

Novartis··NCT05424523·200 enrolled

Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

Completed· Novartis logo

Novartis·Phase 4·NCT00264849·406 enrolled

Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

Completed· Novartis logo

Novartis·Phase 3·NCT00482248·132 enrolled

Omalizumab16 trials

Omalizumab Before Onset of Exacerbations

Recruiting·—·Phase 2·NCT05332067·300 enrolled

Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Completed·CCarsten Bindslev-Jensen·Phase 4·NCT04037176·20 enrolled

The Efficacy of Preseasonal Omalizumab Treatment

Completed·—·N/A·NCT04489121·31 enrolled

Show 13 more trials

Omalizumab to Treat Hyper-IgE (Job's) Syndrome

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00260702·1 enrolled

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

Active, not recruiting·PPhilippe Bégin·Phase 2·NCT04045301·90 enrolled

Omalizumab for Lupus

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 1·NCT01716312·17 enrolled

Sputum-derived Cellular Targets After Xolair (Omalizumab)

Terminated·NNYU Langone Health·Phase 4·NCT02658877·3 enrolled

The Effect of Omalizumab on Responses to Cat Allergen Challenge

Completed·JJohns Hopkins University·N/A·NCT00604786·18 enrolled

mRNA Expression as a Biomarker of Omalizumab Response

Unknown status·IInstituto de Investigação em Imunologia·Phase 4·NCT01584687·6 enrolled

The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

Completed·JJohns Hopkins University·Phase 2·NCT01003301·19 enrolled

Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT01430403·478 enrolled

Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils

Completed·JJohns Hopkins University·Phase 4·NCT02023151·17 enrolled

Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

Completed· Novartis logo

Novartis·Phase 3·NCT01328886·38 enrolled

A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

Completed· Roche logo

Roche·Phase 4·NCT01125748·176 enrolled

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT04998604·360 enrolled

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety

Completed·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT04778137·114 enrolled

Chronic Spontaneous Urticaria12 trials

Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

Completed· Amgen logo

Amgen·Phase 2·NCT04833855·183 enrolled

Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria

Unknown status·CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.·Phase 3·NCT04944602·340 enrolled

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Recruiting·SSimon Francis Thomsen·Phase 4·NCT05916937·40 enrolled

Show 9 more trials

Trial of JYB1904 in Chronic Spontaneous Urticaria.

Recruiting·JJemincare·Phase 2·NCT06509334·135 enrolled

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Completed· Novartis logo

Novartis·Phase 4·NCT02550106·136 enrolled

Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

Completed· Novartis logo

Novartis·Phase 3·NCT02329223·218 enrolled

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

Completed· Novartis logo

Novartis·Phase 3·NCT02161562·314 enrolled

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

Completed· Novartis logo

Novartis·Phase 3·NCT03328897·418 enrolled

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

Completed· Roche logo

Roche·Phase 3·NCT01287117·319 enrolled

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)

Completed· Roche logo

Roche·Phase 3·NCT01292473·323 enrolled

A Global, Multi-center, Open-label Study, Investigating a Remibrutinib- and Omalizumab-Based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-Antihistamines, to Achieve Fast and Well-Controlled Disease Within 24 Weeks

Not yet recruiting· Novartis logo

Novartis·Phase 3·NCT07816328·382 enrolled

A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines and an Open-label 52-week Optional Extension to Assess Long-term Efficacy, Safety and Tolerability of Remibrutinib 25 mg b.i.d.

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06042478·470 enrolled

Chronic Idiopathic Urticaria7 trials

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

Completed· Roche logo

Roche·Phase 3·NCT01264939·336 enrolled

Molecular Endotypes of Chronic Idiopathic Urticaria

Active, not recruiting·UUniversity of Colorado, Denver·Phase 4·NCT04774315·15 enrolled

A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

Completed· Roche logo

Roche·Phase 2·NCT00866788·90 enrolled

Show 4 more trials

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Completed·KKashiv BioSciences, LLC·Phase 3·NCT05774639·600 enrolled

Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

Completed·UUniversity of Colorado, Denver·Phase 4·NCT01701583·10 enrolled

Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)

Completed·JJohns Hopkins University·Phase 4·NCT03111628·18 enrolled

A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

Completed· Roche logo

Roche·Phase 4·NCT02392624·206 enrolled

50 more indications

Urticaria7 trials

Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 2/3·NCT01803763·30 enrolled

Urticaria Facticia Treatment With Omalizumab (UFO)

Completed·—·Phase 2·NCT02169115·61 enrolled

Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

Unknown status·NNational Taiwan University Hospital·N/A·NCT02191072·20 enrolled

Show 4 more trials

Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

Completed· Novartis logo

Novartis·Phase 2·NCT00481676·49 enrolled

Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria

Completed·—·Phase 2·NCT01713725·20 enrolled

Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation

Withdrawn·SSelina Gierer, D.O.·Phase 4·NCT02742805

Omalizumab in Severe and Refractory Solar Urticaria

Completed·—·Phase 2·NCT02262130·10 enrolled

Allergy7 trials

Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma

Unknown status·SScripps Clinic·N/A·NCT00286416·60 enrolled

Omalizumab in the Treatment of Peanut Allergy

Completed·JJohns Hopkins University·Phase 2·NCT00949078·51 enrolled

Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy

Unknown status·CCaroline Nilsson·Phase 2·NCT02402231·23 enrolled

Show 4 more trials

Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1/2·NCT00932282·13 enrolled

Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00078195·168 enrolled

The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Completed·—·Phase 4·NCT00657891·49 enrolled

OIT and Xolair® (Omalizumab) in Cow's Milk Allergy

Completed·HHugh A Sampson, MD·Phase 2·NCT01157117·77 enrolled

Food Allergy5 trials

E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy

Unknown status·XXiu-Min Li·Phase 2·NCT02879006·33 enrolled

Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin

Not yet recruiting·FFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud··NCT07073404·37 enrolled

Effect of Omalizumab in the Skin of Food Allergy Patients

Recruiting·NNational Jewish Health·Phase 4·NCT06618963·40 enrolled

Show 2 more trials

Omalizumab in Severe Asthmatics With Food Allergy

Completed·—··NCT06316414·65 enrolled

Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

Recruiting·JJohns Hopkins University·Phase 2·NCT06934200·32 enrolled

Efficacy and Safety4 trials

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Completed·LLongbio Pharma·Phase 2·NCT06228560·202 enrolled

Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Completed· Novartis logo

Novartis·Phase 2·NCT02477332·382 enrolled

Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)

Completed· Novartis logo

Novartis·Phase 3·NCT01155700·51 enrolled

Show 1 more trial

Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients

Completed· Novartis logo

Novartis·Phase 3·NCT03369704·337 enrolled

Immunotherapy4 trials

Biologics and Sublingual Immunotherapy

Not yet recruiting·MMedical University of Silesia·Phase 4·NCT06027073·150 enrolled

Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

Completed·SStanford University·Phase 1·NCT01510626·35 enrolled

Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

Unknown status·—·N/A·NCT02968394·11 enrolled

Show 1 more trial

Multi Immunotherapy to Test Tolerance and Xolair

Completed·KKari Christine Nadeau·Phase 2·NCT02626611·70 enrolled

Atopic Dermatitis3 trials

Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage

Completed·TTechnical University of Munich·Phase 2·NCT01179529

Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis

Completed·SStanford University·Phase 1·NCT01678092·8 enrolled

Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients

Completed·MMedical University of Vienna·Phase 4·NCT00822783

Allergic Disease3 trials

A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases

Completed·YYuhan Corporation·Phase 1·NCT05061524·68 enrolled

A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

Completed·YYuhan Corporation·Phase 1·NCT05564221·46 enrolled

A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases

Completed·YYuhan Corporation·Phase 1·NCT05960708·30 enrolled

Chronic Rhinosinusitis2 trials

Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Recruiting·UUniversitaire Ziekenhuizen KU Leuven··NCT06683261·300 enrolled

Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Completed·JJohns Hopkins University·Phase 1·NCT04583501·21 enrolled

Tics2 trials

Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®

Completed·AAO GENERIUM·Phase 1·NCT04601389·84 enrolled

Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection

Terminated·BBioRay Pharmaceutical Co., Ltd.·Phase 1·NCT04361812·1 enrolled

Anaphylaxis2 trials

A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00890162·16 enrolled

Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).

Terminated·CCarsten Bindslev-Jensen·Phase 4·NCT03964051·7 enrolled

Atopic Asthma2 trials

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)

Completed· Roche logo

Roche·Phase 4·NCT00096954·333 enrolled

Omalizumab in Non-atopic Asthma

Unknown status·KKing's College London·Phase 2/3·NCT01113437·40 enrolled

Immunogenicity2 trials

PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects

Completed·KKashiv BioSciences, LLC·Phase 1·NCT05564611·204 enrolled

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

Completed· Novartis logo

Novartis·Phase 3·NCT00500539·155 enrolled

Treatment2 trials

Xolair Treatment for Milk Allergic Children

Completed·—·Phase 1·NCT00968110·10 enrolled

FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA

Active, not recruiting·—·Phase 4·NCT06437171·20 enrolled

Angioedema2 trials

Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT02966314·12 enrolled

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT01723072·91 enrolled

Eosinophilic Esophagitis2 trials

Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model

Completed·OO & O Alpan LLC·Phase 1·NCT01040598·19 enrolled

A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

Completed·UUniversity of Utah·Phase 2·NCT00123630·30 enrolled

Clinical Trial2 trials

Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

Completed·—·Phase 1/2·NCT01781637·36 enrolled

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

Completed· Roche logo

Roche·Phase 3·NCT03280537·127 enrolled

Desensitization2 trials

Xolair Enhances Oral Desensitization in Peanut Allergic Patients

Completed·LLynda Schneider·Phase 1/2·NCT01290913·13 enrolled

Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

Completed·DDavid Lang·Phase 4·NCT00555971·16 enrolled

Chronic Rhinosinusitis With Nasal Polyps2 trials

An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

Completed· Roche logo

Roche·Phase 3·NCT03478930·249 enrolled

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

Completed· Roche logo

Roche·Phase 3·NCT03280550·138 enrolled

Randomized1 trial

A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01544348·295 enrolled

Safety and Efficacy1 trial

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Completed· Novartis logo

Novartis·Phase 3·NCT03580369·1,072 enrolled

Nasal polyposis1 trial

Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma

Completed·UUniversity Hospital, Ghent·Phase 2·NCT01393340·23 enrolled

Interstitial Nephritis1 trial

Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)

Withdrawn·MMayo Clinic·Phase 2·NCT01893658

Allergic Rhinitis1 trial

The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study

Completed·YYuzuncu Yil University·Phase 4·NCT06806826·50 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels

Withdrawn·NNational Jewish Health·Phase 2·NCT00851370

Bronchitis1 trial

Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Completed·MMcMaster University·Phase 2/3·NCT02049294·11 enrolled

LAI1 trial

Xolair Interventional Study in ASD Patients With Comorbid Atopy

Withdrawn·—·Phase 1·NCT04535817

T-ALL1 trial

A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

Completed· Roche logo

Roche·Phase 2·NCT00382148·10 enrolled

Gastroenteritis1 trial

Omalizumab to Treat Eosinophilic Gastroenteritis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00084097·30 enrolled

MPA1 trial

Completed·SSyneos Health·Phase 1·NCT05053334·165 enrolled

Antibody1 trial

Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects

Completed·JJemincare·Phase 1·NCT05449535·56 enrolled

Biologics1 trial

Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)

Completed·SStanford University·Phase 2·NCT03679676·108 enrolled

Hypersensitivity1 trial

Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction

Completed·YYale University·Phase 1·NCT02266355·9 enrolled

Gastrointestinal1 trial

Gastrointestinal STRING Test With Oral Immunotherapy

Terminated·SStanford University·Phase 1·NCT04943744·13 enrolled

Physical Activity1 trial

A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma

Terminated· Roche logo

Roche·Phase 4·NCT04195958·3 enrolled

Cystic Fibrosis1 trial

An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

Terminated· Novartis logo

Novartis·Phase 4·NCT00787917·14 enrolled

COVID-191 trial

COVID-19 Immunologic Antiviral Therapy With Omalizumab

Unknown status·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 2·NCT04720612·40 enrolled

ESS1 trial

Effect of Xolair on Airway Hyperresponsiveness

Unknown status·—·Phase 4·NCT00208234·22 enrolled

Adjuvant Therapy1 trial

Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

Completed·—·Phase 1·NCT02118987·5 enrolled

Bullous Pemphigoid1 trial

Efficacy and Safety of Omalizumab in Bullous Pemphigoid

Completed·UUniversity of Iowa·Phase 4·NCT00472030·2 enrolled

Immune1 trial

Multi OIT to Test Immune Markers After Minimum Maintenance Dose

Completed·KKari Christine Nadeau, MD PhD·Phase 2·NCT03181009·60 enrolled

Adolescent1 trial

A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Completed· Novartis logo

Novartis·Phase 3·NCT03580356·1,078 enrolled

Interstitial Cystitis1 trial

Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome

Completed·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 3·NCT01294878·3 enrolled

Cold Urticaria1 trial

Cold Urticaria Treatment With Xolair

Completed·—·Phase 2·NCT01580592·31 enrolled

Observational Study1 trial

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar

Recruiting·CCelltrion HealthCare France··NCT07425639·225 enrolled

Nasal Polyps1 trial

Omalizumab Efficacy in Patients With Refractory Nasal Polyps

Unknown status·SShiraz University of Medical Sciences·Phase 4·NCT05405478·2 enrolled

Airway obstruction1 trial

A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma

Completed· Roche logo

Roche·Phase 2·NCT00434434·61 enrolled

Prospective1 trial

A Prospective Study on Optimizing Treatment for ABPA

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT05129033·100 enrolled

Monotherapy1 trial

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT03881696·471 enrolled

Chronic Obstructive Pulmonary Disease (COPD)1 trial

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)

Recruiting·JJohns Hopkins University·Phase 2·NCT07059091·334 enrolled

Unspecified1 trial

A Study to Find a Suitable Dose of Exl-111 for Further Research

Recruiting·EExcellergy Inc.·Phase 1·NCT07356713·70 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 20, 2003

XOLAIR

BLA BLA103976

Sources

References

[1]
ClinicalTrials.gov — 167 trial records for omalizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xolair drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — omalizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for omalizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA103976). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Ig Epsilon Chain C Region Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Roche

Xolair

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Asthma25 trials

Allergic Asthma20 trials

Omalizumab16 trials

Chronic Spontaneous Urticaria12 trials

Chronic Idiopathic Urticaria7 trials

Urticaria7 trials

Allergy7 trials

Food Allergy5 trials

Efficacy and Safety4 trials

Immunotherapy4 trials

Atopic Dermatitis3 trials

Allergic Disease3 trials

Chronic Rhinosinusitis2 trials

Tics2 trials

Anaphylaxis2 trials

Atopic Asthma2 trials

Immunogenicity2 trials

Treatment2 trials

Angioedema2 trials

Eosinophilic Esophagitis2 trials

Clinical Trial2 trials

Desensitization2 trials

Chronic Rhinosinusitis With Nasal Polyps2 trials

Randomized1 trial

Safety and Efficacy1 trial

Nasal polyposis1 trial

Interstitial Nephritis1 trial

Allergic Rhinitis1 trial

Chronic Obstructive Pulmonary Disease1 trial

Bronchitis1 trial

LAI1 trial

T-ALL1 trial

Gastroenteritis1 trial

MPA1 trial

Antibody1 trial

Biologics1 trial

Hypersensitivity1 trial

Gastrointestinal1 trial

Physical Activity1 trial

Cystic Fibrosis1 trial

COVID-191 trial

ESS1 trial

Adjuvant Therapy1 trial

Bullous Pemphigoid1 trial

Immune1 trial

Adolescent1 trial

Interstitial Cystitis1 trial

Cold Urticaria1 trial

Observational Study1 trial

Nasal Polyps1 trial

Airway obstruction1 trial

Prospective1 trial

Monotherapy1 trial

Chronic Obstructive Pulmonary Disease (COPD)1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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