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Omalizumab (Xolair)
Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing IgE from interacting with high-affinity IgE receptors on mast cells and basophils.
Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing IgE from interacting with high-affinity IgE receptors on mast cells and basophils. Used for Moderate to severe allergic asthma, Chronic idiopathic urticaria, Nasal polyposis.
At a glance
| Generic name | Omalizumab (Xolair) |
|---|---|
| Also known as | Anti IgE, Xolair, Omalizumab 150mg |
| Sponsor | McMaster University |
| Drug class | IgE monoclonal antibody |
| Target | Immunoglobulin E (IgE) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | FDA-approved |
Mechanism of action
By sequestering free IgE, omalizumab reduces the activation of mast cells and basophils that would otherwise occur upon allergen exposure. This prevents the release of inflammatory mediators (histamine, tryptase, leukotrienes) that drive allergic and asthmatic responses. The drug effectively dampens the allergic cascade at its initiation point.
Approved indications
- Moderate to severe allergic asthma
- Chronic idiopathic urticaria
- Nasal polyposis
- Food allergy (in combination with oral immunotherapy)
Common side effects
- Injection site reaction
- Headache
- Upper respiratory tract infection
- Arthralgia
- Anaphylaxis
Key clinical trials
- 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
- 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. (PHASE3)
- A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China
- Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
- ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
- A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects. (PHASE1)
- A Study to Find a Suitable Dose of Exl-111 for Further Research (PHASE1)
- Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Omalizumab (Xolair) CI brief — competitive landscape report
- Omalizumab (Xolair) updates RSS · CI watch RSS
- McMaster University portfolio CI