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Omalizumab Injection
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 Injection |
|---|---|
| Also known as | Xolair, ADL-018, Xolair 300 mg, Omlyclo, Placebo Xolair® |
| Sponsor | Rigshospitalet, Denmark |
| Drug class | 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, 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 reduction in IgE-mediated inflammation leads to decreased symptoms and improved disease control in allergic conditions.
Approved indications
- Moderate to severe allergic asthma
- Chronic idiopathic urticaria
- Allergic rhinitis
- Food allergy
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
- 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)
- Omalizumab Weight-Based Dosing Efficacy Trial (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)
- Preventing Asthma in High Risk Kids (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 Injection CI brief — competitive landscape report
- Omalizumab Injection updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI