Xolair

ApprovedBiologic

Roche

Xolair is one of 300 biologic programs targeting Allergy. It is currently in Approved.

Indications

Total Trials

Active Trials

299

Competitors

Pipeline

Status by Indication[3][1]

Indication

AllergyActive, not recruiting

SinusitisActive, not recruiting

Lung DiseaseActive, not recruiting

UrticariaActive, not recruiting

Allergic AsthmaActive, not recruiting

Chronic RhinosinusitisActive, not recruiting

Atopic DermatitisActive, not recruiting

AsthmaActive, not recruiting

Chronic Spontaneous UrticariaActive, not recruiting

Seasonal Allergic RhinitisActive, not recruiting

AllergyPhase 2

Active, not recruiting

SinusitisApproved

Active, not recruiting

Lung DiseaseApproved

Active, not recruiting

UrticariaPhase 2

Active, not recruiting

Allergic AsthmaPhase 3

Active, not recruiting

Chronic RhinosinusitisPhase 2

Active, not recruiting

Atopic DermatitisPreclinical

Active, not recruiting

AsthmaPhase 3

Active, not recruiting

Chronic Spontaneous UrticariaPhase 3

Active, not recruiting

Seasonal Allergic RhinitisPreclinical

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Xolair

Roche

Approved

3 2

Cinqair

Teva

Preclinical

13 3

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

30 4

Asmanex

Novartis

Preclinical

5 5

Spiriva

Boehringer Ingelheim

Preclinical

8 6

Qvar

Chiesi Farmaceutici S.p.A.

Preclinical

8 7

Arcoxia

Aciphex

2 9

Tylenol

KKenvue Brands

Preclinical

1 10

DUPIXENT

Regeneron

Preclinical

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

Clinical

Trials by Indication[1]

Asthma3 trials

An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g

Completed· Roche logo

Roche·Phase 3·NCT00109187

A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)

Completed· Roche logo

Roche·Phase 3·NCT00401596·1,899 enrolled

A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels

Completed· Novartis logo

Novartis·Phase 4·NCT00624832·60 enrolled

Allergic Asthma3 trials

A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma

Completed· Roche logo

Roche·Phase 3·NCT00109200

Immune Dysfunction in Allergic Asthma

Completed·UUniversity of New Mexico·N/A·NCT00189228·18 enrolled

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

Completed·UUniversity of Mississippi Medical Center·Phase 4·NCT00691873·14 enrolled

Immunogenicity2 trials

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

Completed·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT05897008·114 enrolled

Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects

Completed·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT07246252·114 enrolled

Eczema1 trial

Role of Anti-IgE in Severe Childhood Eczema

Completed·GGuy's and St Thomas' NHS Foundation Trust·Phase 4·NCT02300701·62 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

Completed·UUniversity of Mississippi Medical Center·Phase 4·NCT00329381·14 enrolled

14 more indications

Pregnancy1 trial

An Observational Study of the Use and Safety of Xolair® During Pregnancy

Completed· Roche logo

Roche··NCT00373061·309 enrolled

Urticaria1 trial

Effect of Anti-IgE in Chronic Urticaria

Completed·JJohns Hopkins University·Phase 2·NCT00130234·20 enrolled

Tics1 trial

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

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

Chronic Rhinosinusitis1 trial

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Completed·MMassachusetts General Hospital·Phase 2·NCT01066104·27 enrolled

Allergy1 trial

A Safety and Efficacy Study of Xolair in Peanut Allergy

Terminated· Roche logo

Roche·Phase 2·NCT00086606·150 enrolled

Immunotherapy1 trial

Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

Completed·SStanford University·Phase 1/2·NCT02643862·48 enrolled

Anaphylactic Reaction1 trial

Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing

Completed· Roche logo

Roche··NCT00813748·118 enrolled

Atopic Dermatitis1 trial

Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum

Unknown status·NNational Jewish Health··NCT04060550·36 enrolled

Lung Disease1 trial

Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair

Completed·—·Phase 4·NCT00139152·65 enrolled

Chronic Spontaneous Urticaria1 trial

To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria

Recruiting·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 3·NCT06365879·392 enrolled

Seasonal Allergic Rhinitis1 trial

Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

Completed· Novartis logo

Novartis··NCT04648930·50 enrolled

Sinusitis1 trial

Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT00603785

Chronic Idiopathic Urticaria1 trial

Three-month, Single-center Study to Identify Biomarkers/Response to Xolair Therapy in Chronic Idiopathic Urticaria

Completed·—·N/A·NCT02814630·20 enrolled

LAI1 trial

The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Unknown status·—·Phase 4·NCT00673218·25 enrolled

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Xolair. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Xolair compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Xolair. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Approved[1]
Company: Roche

Xolair

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Asthma3 trials

Allergic Asthma3 trials

Immunogenicity2 trials

Eczema1 trial

Safety and Efficacy1 trial

Pregnancy1 trial

Urticaria1 trial

Tics1 trial

Chronic Rhinosinusitis1 trial

Allergy1 trial

Immunotherapy1 trial

Anaphylactic Reaction1 trial

Atopic Dermatitis1 trial

Lung Disease1 trial

Chronic Spontaneous Urticaria1 trial

Seasonal Allergic Rhinitis1 trial

Sinusitis1 trial

Chronic Idiopathic Urticaria1 trial

LAI1 trial

References

Drug Info

Quick Facts

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