Xolair
An injectable biological therapy used to treat allergic asthma, chronic hives, and nasal polyps.
Where Omalizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Omalizumab was the US, on 20 Jun 2003. It is approved in 3 of the 3 regulators tracked here.
- 1 FDA-approved biosimilar, 1 interchangeable: Omlyclo
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Omalizumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Omalizumab works
All drug targets →- Ig epsilon chain C region inhibitor InhibitorTarget: IGHE immunoglobulin heavy constant epsilon✓ In ChEMBL and the Guide to Pharmacology
- Allergic asthmaPhase 3
- AngioedemaPhase 3
- Bullous pemphigoidPhase 3
- Chronic idiopathic urticariaPhase 3
- Chronic interstitial cystitisPhase 3
- Chronic rhinosinusitisPhase 3
- Chronic rhinosinusitis with nasal polypsPhase 3
- Egg allergyPhase 3
- Peanut allergic reactionPhase 3
- Wheat allergic reactionPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201589, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6890, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Omalizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Omalizumab. 3 are current, and 2 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Omalizumab for treating chronic rhinosinusitis with nasal polyps (terminated appraisal) NICE TA678 | Terminated (no company submission) | 24 Feb 2021 | Current |
| Omalizumab for previously treated chronic spontaneous urticaria NICE TA339 | Optimised | 8 Jun 2015 | Current |
| Omalizumab for treating severe persistent allergic asthma NICE TA278 | Recommended | 24 Apr 2013 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Omalizumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 10 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Omalizumab
- ATC code
- R03DX05
- ChEMBL
- CHEMBL1201589
- DrugBank
- DB00043
- CAS number
- 242138-07-4
- FDA UNII
- 2P471X1Z11
- Wikidata
- Q415392
- Wikipedia
- Omalizumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Xolair is used for
XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance ( 1.3 ) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine…
How it works
12.1 Mechanism of Action Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13. Chronic Spontaneous Urticaria Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.