XOLAIR (omalizumab)
XOLAIR is indicated for the treatment of Asthma; Chronic Rhinosinusitis; Nasal Polyps; Food Allergy; Anaphylaxis; Chronic Spontaneous Urticaria.
How XOLAIR Works
Omalizumab binds to circulating IgE, which inhibits the antibody from binding to the high-affinity IgE receptors located on mast cells, basophils, and dendritic cells. This interaction leads to a down-regulation of these receptors and a subsequent reduction in the release of inflammatory mediators. In allergic asthma, this process reduces blood and tissue eosinophils as well as cytokines including IL-4, IL-5, and IL-13. While the drug effectively lowers free IgE levels and down-regulates receptors, the exact mechanism by which these effects improve symptoms of chronic spontaneous urticaria is unknown.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2003-06-20
- Patent Cliff
- 2025
- Revenue
- $384M (Q4-2025)
- Routes
- N/A
- Dosage Forms
- VIAL, SYRINGE
XOLAIR Approval History
What XOLAIR Treats
6 indicationsXOLAIR is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Rhinosinusitis
- Nasal Polyps
- Food Allergy
- Anaphylaxis
- Chronic Spontaneous Urticaria
XOLAIR Boxed Warning
ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAI...
WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. Initiate XOLAIR therapy in a healthcare setting, closely observe patients for an appropriate period of time after XOLAIR administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis. ( 2.6 , 5.1 , 6.1 , 6.2 )
XOLAIR Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
XOLAIR Biosimilars
1 FDA-approved1 can be substituted at the pharmacy without calling the prescriber.
What are biosimilars? Lower-cost alternatives to XOLAIR with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
XOLAIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to XOLAIR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
88 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06365879 | CMAB007-003 | Ph 3 | active not recruiting | To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria |
| NCT03181009 results posted | eProtocol 39519 | Ph 2 | completed | Multi OIT to Test Immune Markers After Minimum Maintenance Dose |
| NCT06042478 | CLOU064A2304 2022-502161-19-00 | Ph 3 | 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. |
| NCT07356713 | Exl-111.101 | Ph 1 | recruiting | A Study to Find a Suitable Dose of Exl-111 for Further Research |
| NCT07342803 | P10-LP003-05 | Ph 2 | recruiting | Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients |
| NCT03369704 results posted | CIGE025F1301 | Ph 3 | completed | Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients |
| NCT06228560 | P10-LP003-03 | Ph 2 | completed | Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment |
| NCT02570984 PARK | IRB-P00019640 U01AI179563 | Ph 2 | active not recruiting | Preventing Asthma in High Risk Kids |
| NCT04998604 EVEREST results posted | LPS16747 U1111-1255-4713, 2021-000829-27 | Ph 4 | completed | EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients |
| NCT03881696 OUtMATCH results posted | DAIT CoFAR-11 CoFAR-11, NIAID CRMS ID#: 38625 | Ph 3 | completed | Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants |
| NCT06437171 | ML45389 | Ph 4 | active not recruiting | FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA |
| NCT05332067 OBOE | CAUSE-CNH-01 1U01AI160090-01 | Ph 2 | recruiting | Omalizumab Before Onset of Exacerbations |
| NCT06934200 | IRB00467873 | Ph 2 | recruiting | Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels |
| NCT03679676 | IRB-47935 5U19AI104209-07 | Ph 2 | completed | Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE) |
| NCT06438757 | JYB1904-201 | Ph 2 | active not recruiting | Trial of JYB1904 in Patients With Allergic Asthma |
| NCT04833855 INCEPTION results posted | 20190194 | Ph 2 | completed | Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria |
| NCT06806826 rhinitis | 19.12.2018/09 | Ph 4 | completed | The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study |
| NCT05564221 | YH35324-102 | Ph 1 | completed | A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases |
| NCT03580356 results posted | CQGE031C2303 2018-000840-24 | Ph 3 | completed | A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. |
| NCT05061524 | YH35324-101 | Ph 1 | completed | A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases |
| NCT06509334 | JYB1904-202 | Ph 2 | recruiting | Trial of JYB1904 in Chronic Spontaneous Urticaria. |
| NCT05960708 | YH35324-103 | Ph 1 | completed | A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases |
| NCT04774315 | 18-0850 | Ph 4 | active not recruiting | Molecular Endotypes of Chronic Idiopathic Urticaria |
| NCT04037176 | EudraCT 2018-004427-37 | Ph 4 | completed | Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair) |
| NCT06027073 BSIPL | CM-01966 | Ph 4 | not yet recruiting | Biologics and Sublingual Immunotherapy |
| NCT03580369 results posted | CQGE031C2302 2018-000839-28 | Ph 3 | 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 |
| NCT05449535 | JY20210115-Ia CTR20220973 | Ph 1 | completed | Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects |
| NCT05897008 | CMAB007-002 | Ph 1 | completed | The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity |
| NCT01781637 PRROTECT results posted | Peanut 002 | Ph 1, Ph 2 | completed | Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial |
| NCT02966314 results posted | 2016-0645 SMPH/MEDICINE/MEDICINE*A, A534220 | Ph 4 | completed | Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy |
| NCT01716312 | 130005 13-AR-0005 | Ph 1 | completed | Omalizumab for Lupus |
| NCT03478930 results posted | WA40169 2017-003450-16 | Ph 3 | completed | An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps |
| NCT04195958 EDURO results posted | ML41615 | Ph 4 | 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 |
| NCT04778137 | CMAB007-001 | Ph 1 | completed | The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety |
| NCT03111628 results posted | IRB00105590 R01AI116658 | Ph 4 | completed | Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU) |
| NCT02477332 results posted | CQGE031C2201 2014-005559-16 | Ph 2 | completed | Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU |
| NCT01701583 results posted | 12-0780 | Ph 4 | completed | Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria |
| NCT03328897 results posted | CIGE025E2305 | Ph 3 | completed | Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria |
| NCT02169115 UFO results posted | CIGE025EDE17T 2011-005615-87 | Ph 2 | completed | Urticaria Facticia Treatment With Omalizumab (UFO) |
| NCT01723072 X-ACT results posted | CIGE025EDE16 | Ph 3 | completed | Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy |
| NCT01157117 results posted | DAIT AADCRC-MSSM-01 U19AI044236 | Ph 2 | completed | OIT and Xolair® (Omalizumab) in Cow's Milk Allergy |
| NCT03280537 POLYP 2 results posted | GA39855 2017-001718-28 | Ph 3 | completed | A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps |
| NCT03280550 POLYP 1 results posted | GA39688 2017-001724-22 | Ph 3 | completed | A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps |
| NCT02550106 SUNRISE results posted | CIGE025EFR02 | Ph 4 | completed | Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment |
| NCT00603785 | 07030836 BB-IND# 12452 | Ph 4 | withdrawn | Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis |
| NCT02658877 results posted | 14-01160 | Ph 4 | terminated | Sputum-derived Cellular Targets After Xolair (Omalizumab) |
| NCT02654145 results posted | 204471 2015-003697-32 | Ph 4 | completed | Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients |
| NCT02300701 ADAPT | ADAPT | Ph 4 | completed | Role of Anti-IgE in Severe Childhood Eczema |
| NCT01912872 MEXIC results posted | CIGE025AMX02 | Ph 4 | terminated | Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma |
| NCT02266355 | 1408014510 | Ph 1 | completed | Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction |
Showing 50 of 88 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XOLAIR FDA Label Details
Indications & Usage
FDA Label (PDF)XOLAIR is indicated for the treatment of Asthma; Chronic Rhinosinusitis; Nasal Polyps; Food Allergy; Anaphylaxis; Chronic Spontaneous Urticaria.
WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year...
Pro Intelligence Preview
Deep insights for XOLAIR
Revenue Insights
- • Q4-2025: $384M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2025
- • Generic/biosimilar risk
Trial Analysis
- • 91 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment