omalizumab
Trade name: xolair
mAbapproved
Approved
Jun 20, 2003
Omalizumab, sold under the brand name Xolair among others, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives), and immunoglobulin E-mediated food allergy. — Wikipedia
Clinical trial activity
198 trials · 169 clinical orgs · 2 marketing orgs
Phase 1
32
Phase 2
95
Phase 3
51
Phase 4
59
Earliest trial started Jul 1, 2000 (NCT00401596)
Timeline
2000s
2020s
- Mar 7, 2025
Celltrion — Marketing Organization
Indications
Studied for
- Allergy and Immunology · Phase 4
- Anaphylaxis · Phase 2
- Angioedema · Phase 4
- Aspergillosis, Allergic Bronchopulmonary · Phase 4
- Aspirin · Phase 4
- Autism Spectrum Disorder · Phase 1
- Bronchial Spasm · Phase 2
- Bronchitis · Phase 2/Phase 3
- Child · Phase 4
- Chronic Urticaria · Phase 4
- Colonic Neoplasms · Phase 1
- COVID-19 · Phase 2
- Cystic Fibrosis · Phase 4
- Cystitis, Interstitial · Phase 3
- Dermatitis, Atopic · Phase 4
- Drug Hypersensitivity · Phase 1
- Eosinophilia · Early Phase 1
- Eosinophilic Esophagitis · Phase 1
- Esophagitis · Phase 2
- Food Hypersensitivity · Phase 4
- Gastroenteritis · Phase 2
- Healthy Volunteers · Phase 1
- Hypersensitivity · Phase 4
- Hypotension · Phase 2
- Immune System Diseases · Phase 1
- Immunotherapy · Phase 2
- Infertility, Female · Phase 2
- Job Syndrome · Phase 1
- Lung Diseases · Phase 4
- Lupus Erythematosus, Systemic · Phase 1
- Mastocytosis · Phase 2/Phase 3
- Milk Hypersensitivity · Phase 2
- Nasal Polyps · Phase 4
- Nephritis · Phase 2
- Omalizumab · Phase 2
- Peanut Hypersensitivity · Phase 3
- Pemphigoid, Bullous · Phase 4
- Pharmacokinetics · Phase 1
- Physiological Effects of Drugs · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 2
- Rhinitis · Phase 2
- Rhinitis, Allergic · Phase 4
- Rhinitis, Allergic, Seasonal · Phase 3
- Signs and Symptoms · Phase 2
- Sinusitis · Phase 4
- Sjogren's Syndrome · Phase 1
- Virus Diseases · Phase 2
Mechanism of action
- Ig epsilon chain C regionINHIBITOR
IGHE inhibitor
Should be protein complex but not trivial to define
- Immunoglobulin epsilon heavy chainINHIBITOR
Immunoglobulin epsilon heavy chain inhibitor
Approval history
- approvedJun 20, 2003
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaOmalizumab ↗
- NCATS2P471X1Z11 ↗
- ChEMBLCHEMBL1201589 ↗
Also known as
- anti-ige
- anti-ige
- anti-ige antibodies
- anti-igeid
- ige025
- ige25
- olizumab
- olizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- omalizumab
- rg-3648
- rhumab-e25
- rhumab-e25
- rhumab-e25
- xolair
- xolair
- xolair
- xolair
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07059091 | Phase 2 | Jan 31, 2026 | American Lung Association, Genentech, Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT06943534 | Phase 2 | Jun 1, 2025 | Harvard University |
| NCT06934200 | Phase 2 | May 19, 2025 | Genentech, Johns Hopkins University |
| NCT06929052 | Phase 1 | Jan 29, 2025 | Kashiv BioSciences, LLC |
| NCT06618963 | Phase 4 | Oct 1, 2024 | Roche, University of Colorado, Denver |
| NCT06509334 | Phase 2 | Jul 15, 2024 | Jemincare |
| NCT06438757 | Phase 2 | Jun 19, 2024 | Jemincare, Jiao Tong University |
| NCT06365879 | Phase 3 | Jun 18, 2024 | Fudan University, Taizhou Mabtech Pharmaceutical Co., Ltd. |
| NCT06437171 | Phase 4 | Jun 3, 2024 | AAADRS Clinical Research Center |
| NCT06027073 | Phase 4 | May 1, 2024 | Silesian University of Medicine |
| NCT07246252 | Phase 1 | Mar 28, 2024 | Jiao Tong University, Taizhou Mabtech Pharmaceutical Co., Ltd. |
| NCT06228560 | Phase 2 | Jan 25, 2024 | Longbio Pharma |
| NCT06042478 | Phase 3 | Nov 15, 2023 | Novartis |
| NCT05916937 | Phase 4 | Sep 1, 2023 | Aarhus University, University of Copenhagen |
| NCT05960708 | Phase 1 | Aug 23, 2023 | Ajou University, Yuhan Pharmaceutical Company |
| NCT05774639 | Phase 3 | Aug 15, 2023 | COD Research Private Ltd, Kashiv BioSciences, LLC |
| NCT06494345 | Phase 1 | Jan 15, 2023 | AO GENERIUM |
| NCT06869382 | Phase 4 | Jan 1, 2023 | Tzu Chi University |
| NCT05564611 | Phase 1 | Nov 4, 2022 | Kashiv BioSciences, LLC |
| NCT05564221 | Phase 1 | Nov 1, 2022 | Ajou University, Yuhan Pharmaceutical Company |
Showing 20 of 198 trials
Page 1 / 10
Organizations
Research & Development (169)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novartis | For profit | 62 | 37 | 5 | 2001 |
| Genentech | For profit | 46 | 16 | 5 | 2000 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 16 | 7 | 5 | 2003 |
| Johns Hopkins University | Academic/Hospital | 11 | 10 | 5 | 2004 |
| Stanford University | Academic/Hospital | 10 | 7 | 3 | 2004 |
| Harvard University | Academic/Hospital | 8 | 8 | 3 | 2009 |
| Roche | For profit | 6 | 4 | 2 | 2013 |
| University of Colorado, Denver | Academic/Hospital | 6 | 4 | 2 | 2006 |
| Creighton University | Academic/Hospital | 5 | 4 | 2 | 2003 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 4 | 2 | 1 | 2010 |
| Kashiv BioSciences, LLC | For profit | 4 | 4 | 2 | 2022 |
| Taizhou Mabtech Pharmaceutical Co., Ltd. | For profit | 4 | 4 | 2 | 2020 |
| Tanox | For profit | 4 | 0 | 2 | 2005 |
| AO GENERIUM | For profit | 3 | 3 | 2 | 2017 |
| Jemincare | For profit | 3 | 3 | 2 | 2022 |
| Jiao Tong University | Academic/Hospital | 3 | 0 | 2 | 2022 |
| Northwestern University | Academic/Hospital | 3 | 0 | 2 | 2006 |
| University of Mississippi | Academic/Hospital | 3 | 3 | 2 | 2004 |
| Yuhan Pharmaceutical Company | For profit | 3 | 3 | 1 | 2021 |
| Ajou University | Academic/Hospital | 2 | 0 | 1 | 2022 |
169 organizations
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