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Placebo to omalizumab
Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human immunoglobulin E (IgE) with high affinity.
Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human immunoglobulin E (IgE) with high affinity. Used for Chronic idiopathic urticaria, Asthma.
At a glance
| Generic name | Placebo to omalizumab |
|---|---|
| Sponsor | Novartis |
| Drug class | Monoclonal antibody |
| Target | IgE |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This binding prevents the interaction of IgE with its high-affinity receptor on mast cells and basophils, thereby inhibiting the release of mediators involved in allergic inflammation. Omalizumab also reduces the levels of free IgE in the blood, which can contribute to the development of allergic symptoms.
Approved indications
- Chronic idiopathic urticaria
- Asthma
Common side effects
- Injection site reaction
- Headache
- Nausea
- Fatigue
- Muscle pain
Key clinical trials
- 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 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)
- 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)
- Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment (PHASE2)
- Preventing Asthma in High Risk Kids (PHASE2)
- EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (PHASE4)
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:
- Placebo to omalizumab CI brief — competitive landscape report
- Placebo to omalizumab updates RSS · CI watch RSS
- Novartis portfolio CI