Last reviewed · How we verify
EU-approved Xolair
Xolair is a monoclonal antibody that binds to immunoglobulin E (IgE) and prevents its interaction with high-affinity IgE receptors on mast cells and basophils, thereby reducing allergic cascade activation.
Xolair is a monoclonal antibody that binds to immunoglobulin E (IgE) and prevents its interaction with high-affinity IgE receptors on mast cells and basophils, thereby reducing allergic cascade activation. Used for Moderate to severe allergic asthma, Chronic idiopathic urticaria, Allergic rhinitis (in some markets).
At a glance
| Generic name | EU-approved Xolair |
|---|---|
| Also known as | Omalizumab |
| Sponsor | Celltrion |
| Drug class | IgE monoclonal antibody |
| Target | Immunoglobulin E (IgE) |
| Modality | Biologic |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
By sequestering circulating IgE, Xolair reduces the amount of IgE available to cross-link FcεRI receptors on mast cells and basophils. This prevents degranulation and release of inflammatory mediators (histamine, tryptase, leukotrienes) that drive allergic symptoms. The reduction in IgE-mediated activation leads to decreased allergic inflammation across multiple tissues.
Approved indications
- Moderate to severe allergic asthma
- Chronic idiopathic urticaria
- Allergic rhinitis (in some markets)
Common side effects
- Injection site reactions
- Headache
- Upper respiratory tract infection
- Arthralgia
- Fatigue
Key clinical trials
- To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (PHASE3)
- Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (PHASE1)
- To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects (PHASE1)
- To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects (PHASE1)
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:
- EU-approved Xolair CI brief — competitive landscape report
- EU-approved Xolair updates RSS · CI watch RSS
- Celltrion portfolio CI