Omalizumab clinical trials
Omalizumab is named as an intervention in 11 current clinical trials in our France, Spain, Canada, South Korea, Taiwan, China, Belgium, UK, India, Germany, Italy, Netherlands, Poland, Switzerland, Czechia, Turkey, Brazil, Mexico, Japan and Australia registers. 9 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Novartis Pharmaceuticals (2). The most-studied condition is Chronic Spontaneous Urticaria. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
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 (2026.3.1), 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.
Trials by status
Trials by phase
Clinical trials of Omalizumab
11 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Omalizumab in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Omalizumab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin
2025-524629-42-00 · CTIS ↗ · Not possible to specify
|
Phase 2 | Authorised | Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud | Spain |
|
OmaMig Pilot: An open-label, phase IIa, single arm pilot study evaluating the potential clinical benefit and safety of omalizumab in adults with episodic migraine.
2025-522448-41-00 · CTIS ↗ · Nervous System Diseases
|
Phase 2 | Authorised | Oslo University Hospital HF | Norway |
Omalizumab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
10 single-substance products containing Omalizumab on the HPRA medicines list.
- Omlyclo 150 mg solution for injection in pre-filled syringeCelltrion Healthcare Hungary Kft. · EU/1/24/1817/002-004
- Omlyclo 300 mg solution for injection in pre-filled penCelltrion Healthcare Hungary Kft. · EU/1/24/1817/018-021
- Omlyclo 300 mg solution for injection in pre-filled syringeCelltrion Healthcare Hungary Kft. · EU/1/24/1817/014-017
- Omlyclo 75 mg solution for injection in pre-filled syringeCelltrion Healthcare Hungary Kft. · EU/1/24/1817/001
- Xolair 150 mg powder and solvent for solution for injectionNovartis Europharm Limited · EU/1/05/319/002
Supply shortages
No entry for Omalizumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Omalizumab
10 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 2 |
| Jemincare | 1 |
| Longbio Pharma | 1 |
| University Hospital, Lille | 1 |
| Celltrion HealthCare France | 1 |
| Fundación Academia Española de Dermatología | 1 |
| Universitaire Ziekenhuizen KU Leuven | 1 |
| University Hospital, Ghent | 1 |
| Taichung Veterans General Hospital | 1 |
| Excellergy Inc | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Omalizumab trials
How many clinical trials are testing Omalizumab?
11 current trials in our France, Spain, Canada, South Korea, Taiwan, China, Belgium, UK, India, Germany, Italy, Netherlands, Poland, Switzerland, Czechia, Turkey, Brazil, Mexico, Japan and Australia registers name Omalizumab as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Omalizumab trials recruiting patients?
Yes. 9 of the 11 trials are recruiting: 1 with sites in France, 1 with sites in Spain, 1 with sites in Canada, 1 with sites in South Korea, 1 with sites in Taiwan, 2 with sites in China, 2 with sites in Belgium, 1 with sites in Japan and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Omalizumab clinical trials?
Novartis Pharmaceuticals (2), Jemincare (1), Longbio Pharma (1) and University Hospital, Lille (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Omalizumab licensed in Ireland?
Yes. The HPRA medicines list includes 10 single-substance products containing Omalizumab, for example Omlyclo 150 mg solution for injection in pre-filled syringe (Celltrion Healthcare Hungary Kft.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Omalizumab shortage?
Not in the lists we track: Omalizumab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Omalizumab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Omalizumab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Omalizumab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.