Last reviewed 2026-04-20 · How we verify

Xolair (omalizumab)

At a glance

Approved indications

• Asthma
• Chronic idiopathic urticaria
• Seasonal allergic rhinitis

Boxed warnings

• WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. Initiate XOLAIR therapy in a healthcare setting, closely observe patients for an appropriate period of time after XOLAIR administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis. ( 2.6 , 5.1 , 6.1 , 6.2 )

Common side effects

• Injection site reaction
• Viral infections
• Upper respiratory tract infection
• Sinusitis
• Headache
• Pharyngitis
• Severe injection site reactions

Serious adverse events

• Anaphylaxis

Key clinical trials

• Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma (Phase 2)
• The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies (Phase 4)
• Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab (NA)
• An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABP (Phase 4)
• A 24 Week, Open Label, Multi-center Evaluation of Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Ast (Phase 3)
• A 15 Months, Double-Blind, Randomized Controlled Trial Comparing 20 Weeks of Two Dosages of Omalizumab to Placebo to Accelerate a Symptom-driven Oral Immunotherapy Schedule in Subjects Aged 6 to 25 Ye (Phase 2)
• Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma (Phase 2)
• Similarities and Differences of Biological Therapies for Severe Asthma. (N/A)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Xolair CI brief — competitive landscape report
• Xolair updates RSS · CI watch RSS
• Roche portfolio CI