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Xolair Prefilled Syringe
Xolair Prefilled Syringe is a Monoclonal antibody (anti-IgE) Small molecule drug developed by Kashiv BioSciences, LLC. It is currently in Phase 3 development for Moderate to severe allergic asthma, Chronic idiopathic urticaria, Allergic rhinitis (in some formulations).
Xolair (omalizumab) is a monoclonal antibody that binds to circulating immunoglobulin E (IgE) and prevents its interaction with high-affinity IgE receptors on mast cells and basophils, thereby reducing allergic cascade activation.
Xolair (omalizumab) is a monoclonal antibody that binds to circulating 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 formulations).
At a glance
| Generic name | Xolair Prefilled Syringe |
|---|---|
| Sponsor | Kashiv BioSciences, LLC |
| Drug class | Monoclonal antibody (anti-IgE) |
| Target | Immunoglobulin E (IgE) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
By sequestering free IgE, omalizumab 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 prefilled syringe formulation provides a convenient subcutaneous delivery method for this anti-IgE therapy.
Approved indications
- Moderate to severe allergic asthma
- Chronic idiopathic urticaria
- Allergic rhinitis (in some formulations)
Common side effects
- Injection site reaction
- Headache
- Upper respiratory tract infection
- Arthralgia
- Fatigue
- Anaphylaxis
Key clinical trials
- Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (PHASE3)
- To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (PHASE3)
- Omalizumab Before Onset of Exacerbations (PHASE2)
- Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (PHASE1)
- Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (PHASE3)
- A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (PHASE1)
- A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (PHASE1)
- Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). (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:
- Xolair Prefilled Syringe CI brief — competitive landscape report
- Xolair Prefilled Syringe updates RSS · CI watch RSS
- Kashiv BioSciences, LLC portfolio CI
Frequently asked questions about Xolair Prefilled Syringe
What is Xolair Prefilled Syringe?
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Related
- Drug class: All Monoclonal antibody (anti-IgE) drugs
- Target: All drugs targeting Immunoglobulin E (IgE)
- Manufacturer: Kashiv BioSciences, LLC — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Moderate to severe allergic asthma
- Indication: Drugs for Chronic idiopathic urticaria
- Indication: Drugs for Allergic rhinitis (in some formulations)
- Compare: Xolair Prefilled Syringe vs similar drugs
- Pricing: Xolair Prefilled Syringe cost, discount & access