BLASUBCUTANEOUSVIAL
Approved
Jun 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
44
Data completeness
5/8 — Partial
XOLAIR (omalizumab) by Roche is ige-directed antibody interactions [moa]. Approved for anti-ige [epc]. First approved in 2003.
Drug data last refreshed 13h ago · AI intelligence enriched 16h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOLAIR (omalizumab) is a monoclonal antibody that binds to circulating IgE, reducing allergic cascade activation in patients with moderate-to-severe allergic asthma and chronic idiopathic urticaria. It represents a foundational biologic therapy that pioneered the anti-IgE mechanism class. The drug is administered subcutaneously and requires dose titration based on baseline IgE levels and body weight.
$0.254BPart D
LOE ApproachingBrand is in late-stage maturity with approaching loss of exclusivity; expect transition from growth-focused teams to optimization and lifecycle management roles.
Mechanism of Action
IgE-directed Antibody Interactions
Pharmacologic Class:
Anti-IgE
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (44)
A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China
Started Mar 2026
3,485 enrolled
Chronic Urticaria
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
Started Feb 2026
334 enrolled
Chronic Obstructive Pulmonary Disease (COPD)Allergies
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
Started Oct 2025
225 enrolled
Chronic Spontaneous Urticaria (CSU)Allergic Asthma
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
Started May 2025
32 enrolled
Food Hypersensitivity
Effect of Omalizumab in the Skin of Food Allergy Patients
Started Oct 2024
40 enrolled
Food AllergyFood Allergy in Children
Worked on XOLAIR at Roche? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.