Last reviewed 2026-04-20 · How we verify

Xolair

At a glance

Approved indications

• Asthma
• Chronic idiopathic urticaria
• Seasonal allergic rhinitis

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

• 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
• 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 Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China
• Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
• ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
• 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)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

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
• Taizhou Mabtech Pharmaceutical Co.,Ltd portfolio CI