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ANTI-IGE THERAPY (XOLAIR)
Xolair (omalizumab) is a monoclonal antibody that binds to circulating IgE, preventing it from interacting with high-affinity IgE receptors on mast cells and basophils.
Xolair (omalizumab) is a monoclonal antibody that binds to circulating IgE, preventing it from interacting with high-affinity IgE receptors on mast cells and basophils. Used for Moderate to severe allergic asthma, Chronic idiopathic urticaria, Allergic rhinitis (off-label use).
At a glance
| Generic name | ANTI-IGE THERAPY (XOLAIR) |
|---|---|
| Sponsor | Children's Hospital of The King's Daughters |
| Drug class | Anti-IgE monoclonal antibody |
| Target | Immunoglobulin E (IgE) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy / Respiratory |
| Phase | FDA-approved |
Mechanism of action
By sequestering free IgE in the bloodstream, omalizumab reduces the amount of IgE available to cross-link receptors on mast cells and basophils, thereby suppressing the release of inflammatory mediators (histamine, tryptase, leukotrienes) that drive allergic and asthmatic responses. This mechanism reduces both the immediate hypersensitivity reaction and downstream allergic inflammation.
Approved indications
- Moderate to severe allergic asthma
- Chronic idiopathic urticaria
- Severe allergic reactions to specific allergens
Common side effects
- Injection site reaction
- Headache
- Upper respiratory tract infection
- Arthralgia
- Fatigue
Key clinical trials
- Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (PHASE2)
- Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients (PHASE2)
- Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients (PHASE3)
- EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (PHASE4)
- Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (PHASE3)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA (PHASE4)
- Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels (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:
- ANTI-IGE THERAPY (XOLAIR) CI brief — competitive landscape report
- ANTI-IGE THERAPY (XOLAIR) updates RSS · CI watch RSS
- Children's Hospital of The King's Daughters portfolio CI