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 42m ago · AI intelligence enriched 42m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human immunoglobulin E (IgE), reducing circulating free IgE levels. It is indicated for moderate-to-severe allergic asthma and chronic idiopathic urticaria in patients with positive IgE serology. The drug works by forming small immune complexes with IgE, preventing interaction with high-affinity IgE receptors on mast cells and basophils, thereby reducing allergic cascade activation.
$254MPart D
LOE ApproachingApproaching loss of exclusivity with steady Part D utilization (~79K claims in 2023) suggests defensive franchise management and transition planning will dominate career focus.
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)
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
Started Sep 2026
382 enrolled
Chronic Spontaneous Urticaria
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
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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.