Omalizumab
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | XOLAIR | — | 2010-01-04 – 2024-02-16 | fda.gov ↗ |
| Approved | EU (EMA) | Xolair | — | 2005-10-25 | europa.eu ↗ |
| Approved | US (FDA) | XOLAIR | — | 2003-06-20 | fda.gov ↗ |
Trials 136 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04943744 | May 2021 → May 2024 | eosinophil disorder, food allergy | Stanford University | Terminated | No outcome recorded |
| Phase 0 | NCT04583501 | Dec 2020 → Jul 2024 | chronic rhinosinusitis, nasal cavity polyp | Johns Hopkins University | Completed | No outcome recorded |
| Phase 0 | NCT00968110 | Mar 2009 → Apr 2017 | food allergy | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT07356713 | Jan → Dec 2026 expected | allergic disease | Excellergy Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05564611 | Nov 2022 → Jul 2023 | — | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05053334 | Feb 2022 → Jan 2024 | — | Syneos Health | Completed | No outcome recorded |
| Phase 1 | NCT05897008 | Feb → Jun 2022 | — | Taizhou Mabtech Pharmaceutical Co.,Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04535817 | Jan 2021 → Jan 2022 | atopic IgE-mediated allergic disorder, autism spectrum disorder | Beth Israel Deaconess Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT04778137 | Dec 2020 → Apr 2021 | asthma | Taizhou Mabtech Pharmaceutical Co.,Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04018313 | May 2020 → Mar 2021 | — | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT02266355 | Nov 2014 → Feb 2018 | colon carcinoma | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT02118987 | Jul 2014 → Dec 2017 | drug allergy | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01510626 | Nov 2011 → Apr 2014 | immune system disorder | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT01040598 | Jun 2009 → Dec 2011 | eosinophilic esophagitis | O & O Alpan LLC | Completed | No outcome recorded |
| Phase 1 | NCT00260702 | Nov 2005 → Mar 2010 | hyper-IgE syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01678092 | May 2004 → Dec 2006 | atopic eczema | Stanford University | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01781637 | Jan 2013 → Oct 2015 | food allergy | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT01290913 | Feb 2011 → Sep 2013 | food allergy | Lynda Schneider | Completed | No outcome recorded |
| Phase 225 trials | ||||||
| Phase 2 | NCT06934200 | May 2025 → Apr 2027 expected | food allergy | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT05332067 | May 2022 → Jan 2028 expected | atopic IgE-mediated allergic disorder, childhood onset asthma, viral respiratory tract infection | Children's National Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04720612 | Oct 2021 → Nov 2022 | COVID-19 | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 2 | NCT03679676 | Feb 2020 → Apr 2025 | food allergy, insect Stings, hypersensitivity to | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT04045301 | Nov 2019 → Dec 2025 overdue | food allergy | Philippe Bégin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02262130 | Sep 2014 → Sep 2015 | solar urticaria | Centre Hospitalier Universitaire de Besancon | Completed | No outcome recorded |
| Phase 2 | NCT02402231 | Oct 2013 → Oct 2020 | food allergy | Caroline Nilsson | Unknown | No outcome recorded |
| Phase 2 | NCT02169115 | Dec 2012 → Dec 2014 | urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT01580592 | Apr 2012 → Dec 2014 | cold urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT01599637 | Apr 2012 → Sep 2013 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01157117 | Aug 2010 → Jan 2015 | food allergy | Hugh A Sampson, MD | Completed | No outcome recorded |
| Phase 2 | NCT01003301 | Oct 2009 → Dec 2012 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00949078 | Jul 2009 → Aug 2011 | food allergy | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00866788 | Mar 2009 → Jan 2010 | chronic idiopathic urticaria | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00851370 | Jan 2009 → Feb 2011 | chronic obstructive pulmonary disease | National Jewish Health | Withdrawn | No outcome recorded |
| Phase 2 | NCT00434434 | Oct 2007 → Feb 2009 | allergic asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00481676 | May 2007 → Apr 2009 | chronic urticaria | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00382148 | Nov 2006 → Jun 2008 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00123630 | Nov 2005 → Jan 2010 | esophagitis | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT00162773 | Apr 2005 → Sep 2009 | asthma | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 2 | NCT00130234 | Nov 2004 → Sep 2007 | urticaria | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00084097 | Jun 2004 → Feb 2007 | gastroenteritis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00086606 | Jun 2004 → Apr 2006 | food allergy | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00078195 | Apr 2003 → May 2005 | seasonal allergic rhinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01179529 | — | atopic eczema | Technical University of Munich | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT01333293 | Sep 2011 → Oct 2015 | mastocytosis | University of Zurich | Completed | No outcome recorded |
| Phase 2/3 | NCT01976208 | Dec 2010 → Dec 2015 | allergic asthma | Shanghai Zhangjiang Biotechnology Limited Company | Completed | No outcome recorded |
| Phase 2/3 | NCT01113437 | Apr 2010 → Aug 2012 | asthma | King's College London | Unknown | No outcome recorded |
| Phase 2/3 | NCT00180011 | Sep 2005 → Feb 2012 | asthma | DiMango, Emily, M.D. | Completed | No outcome recorded |
| Phase 335 trials | ||||||
| Phase 3 | NCT05774639 | Aug 2023 → Oct 2024 | chronic idiopathic urticaria | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 3 | NCT05390255 | May 2022 → Dec 2024 | sinusitis | Beijing Tongren Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04976192 | Aug 2021 → Apr 2024 | chronic urticaria | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 3 | NCT03881696 | Jul 2019 → Mar 2023 | food allergy | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04607629 | Jun 2018 → Apr 2019 | asthma | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT03478930 | May 2018 → Mar 2020 | chronic rhinosinusitis, nasal cavity polyp | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03369704 | Dec 2017 → May 2018 | seasonal allergic rhinitis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03280537 | Nov 2017 → Mar 2019 | chronic rhinosinusitis, nasal cavity polyp | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03280550 | Nov 2017 → Mar 2019 | chronic rhinosinusitis, nasal cavity polyp | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03328897 | Apr 2017 → Jul 2019 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04128176 | Mar 2017 → May 2023 | bullous pemphigoid | University of California, Davis | Withdrawn | No outcome recorded |
| Phase 3 | NCT02329223 | Dec 2014 → Dec 2015 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02161562 | Aug 2014 → Nov 2016 | chronic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02166151 | Jul 2014 → Jun 2016 | chronic idiopathic urticaria | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01723072 | Jan 2013 → May 2014 | angioedema, chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01328886 | Mar 2011 → Dec 2013 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01292473 | Mar 2011 → Jun 2012 | chronic idiopathic urticaria | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01287117 | Feb 2011 → Oct 2012 | chronic idiopathic urticaria | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01264939 | Feb 2011 → Nov 2012 | chronic idiopathic urticaria | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01202903 | Sep 2010 → Oct 2013 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01155700 | Jun 2010 → Feb 2012 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01007149 | Sep 2009 → Feb 2011 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01294878 | Mar 2009 → Sep 2010 | interstitial cystitis | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| Phase 3 | NCT00500539 | Jul 2007 → Sep 2008 | asthma | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00314574 | Dec 2005 → Nov 2009 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00079937 | Apr 2004 → Mar 2008 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00219323 | Nov 2003 → Mar 2006 | asthma | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00482248 | Jun 2003 → Jun 2006 | asthma | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00109200 | May → Sep 2003 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00482508 | May 2003 → Oct 2005 | asthma | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00232050 | Oct 2002 → May 2005 | asthma | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00829179 | Oct 2002 → Jul 2004 | allergic asthma | Duke University | Completed | No outcome recorded |
| Phase 3 | NCT00109187 | Jun 2002 → Apr 2003 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00046748 | Dec 2001 → Apr 2004 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00401596 | Jul 2000 → Jul 2002 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 444 trials | ||||||
| Phase 4 | NCT06437171 | Jun 2024 → Jul 2026 overdue | food allergy | AAADRS Clinical Research Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06869382 | Jan → Dec 2023 | asthma | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Completed | No outcome recorded |
| Phase 4 | NCT05405478 | Jun → Dec 2022 | nasal cavity polyp | Shiraz University of Medical Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT04774315 | Jan 2022 → Mar 2025 overdue | chronic idiopathic urticaria | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04998604 | Sep 2021 → Oct 2024 | asthma, chronic rhinosinusitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT05001529 | Mar 2021 → Mar 2022 | asthma | Scarlata, Simone, M.D. | Unknown | No outcome recorded |
| Phase 4 | NCT04195958 | Nov 2020 → Oct 2021 | allergic asthma | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT03964051 | Jul 2019 → Dec 2020 | food allergy | Carsten Bindslev-Jensen | Terminated | No outcome recorded |
| Phase 4 | NCT03111628 | Oct 2017 → May 2020 | chronic urticaria | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT02658877 | Jan 2016 → Jul 2018 | asthma | NYU Langone Health | Terminated | No outcome recorded |
| Phase 4 | NCT02392624 | May 2015 → Mar 2017 | urticaria | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02550106 | Apr 2015 → Jan 2016 | chronic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02300701 | Dec 2014 → Aug 2018 | atopic eczema | Guy's and St Thomas' NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT01912872 | Nov 2013 → Aug 2015 | allergic asthma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT01922037 | Jun 2013 → Mar 2016 | asthma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01701583 | Apr 2013 → Apr 2016 | chronic urticaria | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT02023151 | Feb 2013 → Jun 2016 | allergic asthma | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT01584687 | Jun → Dec 2012 | asthma | Instituto de Investigação em Imunologia | Unknown | No outcome recorded |
| Phase 4 | NCT01430403 | Sep 2011 → Dec 2013 | asthma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT01125748 | May 2010 → Aug 2013 | allergic asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00870584 | Mar 2009 → Mar 2010 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00784485 | Feb 2009 → Feb 2011 | asthma | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 4 | NCT00787917 | Nov 2008 → Jul 2010 | allergic bronchopulmonary aspergillosis, cystic fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT00777764 | Aug 2008 → Apr 2009 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00624832 | Feb 2008 → Jan 2009 | asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00603785 | Jan → Apr 2008 | chronic rhinosinusitis | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 4 | NCT00495612 | Sep 2007 → Jun 2009 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00472030 | Aug 2007 → Dec 2010 | bullous pemphigoid | University of Iowa | Completed | No outcome recorded |
| Phase 4 | NCT00546143 | Jul 2007 → Aug 2008 | asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00673218 | Jun 2007 → Nov 2012 | allergic disease | Creighton University | Unknown | No outcome recorded |
| Phase 4 | NCT00657891 | Mar → Oct 2007 | asthma | Creighton University | Completed | No outcome recorded |
| Phase 4 | NCT00377572 | Oct 2006 → Dec 2009 | asthma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT00329381 | May 2006 → May 2007 | asthma | University of Mississippi Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00691873 | May 2006 → May 2007 | asthma | University of Mississippi Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00096954 | Feb 2006 → Sep 2010 | asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00283504 | Jan 2006 → Jan 2009 | allergic asthma | Children's Hospital of The King's Daughters | Completed | No outcome recorded |
| Phase 4 | NCT00267202 | Dec 2005 → Jan 2008 | allergic asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00264849 | Nov 2005 → Sep 2008 | asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00242359 | Nov 2005 → Jan 2009 | allergic asthma | Bernstein Clinical Research Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT00139152 | Sep 2005 → Dec 2009 | lung disorder | Creighton University | Completed | No outcome recorded |
| Phase 4 | NCT00639691 | Jan 2005 → Dec 2011 | asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00133042 | Dec 2004 → Dec 2006 | asthma | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT00367016 | Feb 2004 → Oct 2012 | allergic rhinitis, asthma, atopic eczema | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT00208234 | Jan 2004 → Sep 2011 | allergic asthma | Creighton University | Unknown | No outcome recorded |
| Phase not applicable10 trials | ||||||
| — | NCT04489121 | Jul → Sep 2020 | seasonal allergic rhinitis | Beijing Tongren Hospital | Completed | No outcome recorded |
| — | NCT02814630 | Sep 2016 → Nov 2018 | chronic idiopathic urticaria | Asthma Inc Clinical Research Center | Completed | No outcome recorded |
| — | NCT02191072 | Jul 2014 → May 2016 | urticaria | National Taiwan University Hospital | Unknown | No outcome recorded |
| — | NCT02968394 | Mar 2014 → Mar 2017 | venom allergy | The University Clinic of Pulmonary and Allergic Diseases Golnik | Unknown | No outcome recorded |
| — | NCT03019237 | Nov 2012 → May 2013 | allergic disease | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT00604786 | Jul 2007 → Jan 2009 | allergic rhinitis | Johns Hopkins University | Completed | No outcome recorded |
| — | NCT00287378 | Mar 2006 → Jul 2007 | allergic disease, asthma | University of North Carolina, Chapel Hill | Terminated | No outcome recorded |
| — | NCT00286416 | Jan 2006 → Jul 2008 | allergic rhinitis, asthma | Scripps Clinic | Unknown | No outcome recorded |
| — | NCT00189228 | Sep 2005 → Jun 2008 | asthma | University of New Mexico | Completed | No outcome recorded |
| — | NCT00226200 | Nov 2004 → Oct 2007 | asthma | University of Mississippi Medical Center | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 64 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07246252 Comparator | Mar → Sep 2024 | — | Taizhou Mabtech Pharmaceutical Co.,Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05960708 Comparator | Aug 2023 → Sep 2024 | allergic disease, chronic idiopathic urticaria, chronic inducible urticaria, cold urticaria | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05564221 Comparator | Nov 2022 → Nov 2024 | atopic IgE-mediated allergic disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05413161 Comparator | Jul 2022 → Feb 2023 | — | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05449535 Comparator | May 2022 → Jan 2023 | — | Jemincare | Completed | No outcome recorded |
| Phase 1 | NCT05061524 Comparator | Sep 2021 → Jan 2023 | atopic IgE-mediated allergic disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04361812 Comparator | Oct 2020 → Dec 2021 | — | BioRay Pharmaceutical Co., Ltd. | Terminated | No outcome recorded |
| Phase 1 | NCT04601389 Comparator | Apr → Sep 2017 | — | AO GENERIUM | Completed | No outcome recorded |
| Phase 1 | NCT01716312 Comparator | Jan 2014 → Aug 2017 | Sjogren syndrome, systemic lupus erythematosus | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 1 | NCT01544348 Comparator | Jan 2012 → Jun 2013 | allergic asthma, allergic rhinitis, atopic eczema | MedImmune LLC | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02643862 Comparator | Mar 2015 → Aug 2016 | food allergy | Stanford University | Completed | No outcome recorded |
| Phase 1/2 | NCT01703312 Comparator | Nov 2012 → Oct 2013 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT00932282 Comparator | Jul 2009 → Aug 2015 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 222 trials | ||||||
| Phase 2 | NCT07059091 Comparator | Feb 2026 → Jan 2031 expected | allergic disease, chronic obstructive pulmonary disease | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT06943534 Comparator | Jul 2025 → May 2027 expected | food allergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07342803 Comparator | Jan 2025 → Dec 2027 expected | allergic asthma | Longbio Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT06509334 Comparator | Aug 2024 → Jul 2026 overdue | chronic idiopathic urticaria | Jemincare | Recruiting | No outcome recorded |
| Phase 2 | NCT06438757 Comparator | Jun 2024 → Nov 2025 | allergic asthma | Jemincare | Completed | No outcome recorded |
| Phase 2 | NCT06228560 Comparator | Jan 2024 → Apr 2025 | chronic urticaria | Longbio Pharma | Completed | No outcome recorded |
| Phase 2 | NCT04833855 Comparator | Apr 2021 → Dec 2022 | chronic urticaria | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT03727971 Comparator | Jan 2019 → Dec 2024 | asthma, female infertility | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT02570984 Comparator | Nov 2018 → Jan 2028 expected | asthma | Boston Children's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01893658 Comparator | Jun → Sep 2018 | acute tubulointerstitial nephritis | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 2 | NCT03181009 Background | Jul 2017 → Dec 2018 | food allergy | Andrew Long, PharmD | Completed | No outcome recorded |
| Phase 2 | NCT06103656 Background | Aug 2016 → Jul 2020 | food allergy | New York Medical College | Completed | No outcome recorded |
| Phase 2 | NCT02879006 Comparator | Aug 2016 → Nov 2020 | food allergy | Xiu-Min Li | Unknown | No outcome recorded |
| Phase 2 | NCT02626611 Comparator | Dec 2015 → Nov 2016 | food allergy | Kari Christine Nadeau | Completed | No outcome recorded |
| Phase 2 | NCT02477332 Comparator | Jul 2015 → Nov 2016 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02012387 Comparator | Jan 2014 → Sep 2016 | cholinergic urticaria | Clinica Universidad de Navarra, Universidad de Navarra | Completed | No outcome recorded |
| Phase 2 | NCT02388997 Comparator | Feb 2013 → May 2017 | asthma | University of Virginia | Completed | No outcome recorded |
| Phase 2 | NCT01716754 Comparator | Dec 2012 → Jan 2016 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01713725 Comparator | Mar 2012 → Feb 2016 | chronic urticaria | Clinica Universidad de Navarra, Universidad de Navarra | Completed | No outcome recorded |
| Phase 2 | NCT01066104 Comparator | Dec 2009 → Jul 2015 | chronic rhinosinusitis, nasal cavity polyp | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00890162 Comparator | Apr 2009 → Jul 2018 | angioedema, bronchial disorder, hypotensive disorder, idiopathic anaphylaxis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01393340 Comparator | Dec 2006 → Oct 2008 | asthma, nasal cavity polyp | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02049294 Comparator | Mar 2014 → Sep 2017 | asthma, chronic bronchitis | McMaster University | Completed | No outcome recorded |
| Phase 2/3 | NCT01803763 Comparator | Sep 2012 → Mar 2014 | chronic idiopathic urticaria, chronic urticaria | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06365879 Comparator | Jun 2024 → Jan 2026 overdue | chronic idiopathic urticaria | Taizhou Mabtech Pharmaceutical Co.,Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06042478 Comparator | Nov 2023 → Sep 2025 overdue | chronic urticaria | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04944602 Comparator | Jul 2021 → Mar 2023 | chronic urticaria | CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05813470 Comparator | Jan 2021 → Jan 2023 | allergic asthma | Cinnagen | Completed | No outcome recorded |
| Phase 3 | NCT04426890 Comparator | Dec 2020 → Oct 2022 | chronic urticaria | Celltrion | Completed | No outcome recorded |
| Phase 3 | NCT03580356 Comparator | Oct 2018 → Jun 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03580369 Comparator | Oct 2018 → Jul 2021 | chronic idiopathic urticaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00396409 Background | Feb 2006 → Aug 2008 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT06824649 Comparator | Jun 2026 → Feb 2030 expected | chronic rhinosinusitis, nasal cavity polyp | Medical University of South Carolina | Recruiting | No outcome recorded |
| Phase 4 | NCT06618963 Comparator | Oct 2024 → Sep 2026 expected | food allergy | National Jewish Health | Recruiting | No outcome recorded |
| Phase 4 | NCT06027073 Comparator | May 2024 → Oct 2026 expected | allergic asthma | Medical University of Silesia | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05916937 Comparator | Jan 2024 → Dec 2025 overdue | chronic idiopathic urticaria | Simon Francis Thomsen | Recruiting | No outcome recorded |
| Phase 4 | NCT04763447 Comparator | May 2021 → May 2027 expected | asthma | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 4 | NCT04037176 Comparator | Nov 2019 → Mar 2022 | food allergy | Carsten Bindslev-Jensen | Completed | No outcome recorded |
| Phase 4 | NCT03476109 Comparator | May 2019 → Dec 2023 | asthma | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Unknown | No outcome recorded |
| Phase 4 | NCT06806826 Comparator | Jan 2019 → Jan 2020 | allergic rhinitis | Yuzuncu Yil University | Completed | No outcome recorded |
| Phase 4 | NCT04585997 Comparator | Nov 2018 → Jun 2022 | asthma | University of Newcastle, Australia | Unknown | No outcome recorded |
| Phase 4 | NCT02966314 Comparator | Mar 2017 → Jan 2020 | angioedema | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT02654145 Background | Mar 2016 → May 2017 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02742805 Background | Feb 2016 → Dec 2018 | urticaria | Selina Gierer, D.O. | Withdrawn | No outcome recorded |
| Phase 4 | NCT00670930 Comparator | Apr 2008 → Nov 2011 | allergic asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00567476 Comparator | Nov 2007 → Apr 2010 | asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00454051 Comparator | Dec 2006 → Mar 2008 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00555971 Comparator | May 2006 → Feb 2016 | aspirin-induced respiratory disease | David Lang | Completed | No outcome recorded |
| Phase 4 | NCT00117611 Comparator | Jul 2005 → May 2007 | chronic rhinosinusitis | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00822783 Comparator | Oct 2001 → Apr 2003 | atopic eczema | Medical University of Vienna | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05129033 Comparator | Nov 2021 → Jun 2023 | allergic bronchopulmonary aspergillosis | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
Press releases naming this drug 20 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗ |
| 2026-03-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗ |
| 2026-03-27 | Novartis Pharmaceuticals | Novartis agrees to acquire Excellergy, Inc., building on allergy leadership with next-generation anti-IgE innovation novartis.com ↗ |
| 2025-06-15 | Sanofi | Press Release: EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study sanofi.com ↗ |
| 2025-06-15 | Regeneron Pharmaceuticals | Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizumab) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Patients with Coexisting Asthma in First-ever Presented Phase 4 Head-to-Head Respiratory Trial regeneron.com ↗ |
| 2025-03-02 | Roche Global Development | Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies roche.com ↗ |
| 2024-02-25 | Roche Global Development | New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions across multiple foods in people with food allergies roche.com ↗ |
| 2024-02-16 | Roche Global Development | FDA approves Xolair as first and only medicine for children and adults with one or more food allergies roche.com ↗ |
| 2023-12-19 | Roche Global Development | FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results roche.com ↗ |
| 2021-04-13 | Roche Global Development | FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications roche.com ↗ |
| 2020-12-01 | Roche Global Development | FDA approves Xolair® (omalizumab) for adults with nasal polyps roche.com ↗ |
| 2020-08-06 | Novartis Pharmaceuticals | Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps novartis.com ↗ |
| 2020-06-26 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps novartis.com ↗ |
| 2020-01-09 | Novartis Pharmaceuticals | Novartis ligelizumab (QGE031) more effective than Xolair® at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria novartis.com ↗ |
| 2019-10-08 | Novartis Pharmaceuticals | Novartis data show more patients are completely symptom-free from chronic spontaneous urticaria with ligelizumab (QGE031) than Xolair® 300 mg novartis.com ↗ |
| 2019-06-03 | Novartis Pharmaceuticals | Xolair® (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies novartis.com ↗ |
| 2018-12-13 | Novartis Pharmaceuticals | Novartis receives European Commission approval for self-administration of Xolair® across all indications novartis.com ↗ |
| 2018-03-06 | Novartis Pharmaceuticals | Novartis' Xolair® recommended in new global chronic urticaria guideline novartis.com ↗ |
| 2017-09-16 | Novartis Pharmaceuticals | Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption novartis.com ↗ |
| 2015-06-12 | Novartis Pharmaceuticals | Novartis reports new analysis showing Xolair® improving quality of life by 78% for chronic spontaneous urticaria patients novartis.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 201 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omalizumab | “A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39,...” NCT04018313 ↗187“Subjects with severe uncontrolled asthma will be assigned to treatment with Omalizumab (anti Ig E antibodies) or Mepolizumab (anti IL-5 antibodies) according to medical advice...” NCT05001529 ↗ “Genolar® (omalizumab) (JSC "GENERIUM", the Russian Federation) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin (IgE) and is a biosimilar of...” NCT04607629 ↗ “BACKGROUND: Omalizumab, a humanized recombinant monoclonal anti-IgE antibody, proved to be effective in patients with chronic spontaneous urticaria (CSU), including severe and...” PMID 29974963 ↗ Oct 2018 “In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients.” NCT00777764 ↗ “Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab.” NCT06824649 ↗ “The purpose of this study is to look at the effectiveness of Xolair® (omalizumab) in people with asthma taking Advair Diskus®.” NCT00784485 ↗ “Omalizumab is a monoclonal antibody that specifically targets immunoglobulin E (IgE), a key mediator in allergic asthma.” NCT06869382 ↗ “Subjects in both groups received a single subcutaneous injection of CMAB007 or Xolair#Omalizumab# 150 mg, respectively.” NCT05897008 ↗ “the monoclonal humanized anti-IgE antibody (Omalizumab) was shown to be effective in control cholinergic urticaria” NCT02012387 ↗ “Omalizumab (OMA) is a monoclonal anti IgE antibody, developed for severe uncontrolled allergic asthma.” NCT04763447 ↗ “Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;” NCT00624832 ↗ “Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma.” NCT00691873 ↗ “Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria” NCT02166151 ↗ “XOLAIR (omalizumab) injection is supplied as a single dose PFS.” NCT04976192 ↗ “The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients” NCT01333293 ↗ “anti-IgE (Omalizumab/Xolair) in children with severe eczema.” NCT02300701 ↗ “Xolair (omalizumab)” NCT07246252 ↗ “Omalizumab” NCT02300701 ↗ |
| Known as | anti-IgE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03019237 ↗ |
| Known as | CT-P39 | “A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39,...” NCT04018313 ↗ |
| Known as | Genolar | “Genolar® (omalizumab) (JSC "GENERIUM", the Russian Federation) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin (IgE) and is a biosimilar of...” NCT04607629 ↗ |
| Known as | OMA | “Omalizumab (OMA) is a monoclonal anti IgE antibody, developed for severe uncontrolled allergic asthma.” NCT04763447 ↗ |
| Known as | Omalizumab (Xolair) | “Omalizumab (Xolair)” NCT00329381 ↗1“Omalizumab (Xolair)” NCT00691873 ↗ |
| Known as | OMB | “Omalizumab (OMB), an anti-IgE monoclonal antibody decreases the release of mediators from mast cells, reduces the frequency of exacerbations and allows a reduction in ICS dose.” NCT00133042 ↗ |
| Known as | RhuMab-E25 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00829179 ↗ |
| Known as | Xolair | “A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39,...” NCT04018313 ↗50“Anti-IgE (Xolair) will be freshly diluted in sterile 0.9% sodium chloride solution (438 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both...” NCT03019237 ↗ “A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine...” NCT02550106 ↗ “This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic...” NCT00084097 ↗ “This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair).” NCT04774315 ↗ “Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds specifically to the FcEpsilonR1 binding site on human IgE.” NCT00130234 ↗ “Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds specifically to the (FceRI) binding site on human IgE.” NCT00162773 ↗ “A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)” NCT00382148 ↗ “The purpose of this study is to look at the effectiveness of Xolair® (omalizumab) in people with asthma taking Advair Diskus®.” NCT00784485 ↗ “Subjects in both groups received a single subcutaneous injection of CMAB007 or Xolair#Omalizumab# 150 mg, respectively.” NCT05897008 ↗ “The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)” NCT00777764 ↗ “For severe asthma inadequately controlled with ICS+LABA, biologics such as omalizumab (Xolair®) may be added.” NCT06869382 ↗ “Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria” NCT03328897 ↗ “The investigators are doing this research study to learn more about a drug called Xolair (omalizumab).” NCT01066104 ↗ “A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma” NCT00242359 ↗ “the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation” NCT04943744 ↗ “Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria” NCT01701583 ↗ “Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks.” NCT00096954 ↗ “XOLAIR (omalizumab) injection is supplied as a single dose PFS.” NCT05774639 ↗ “The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients” NCT01333293 ↗ “anti-IgE (Omalizumab/Xolair) in children with severe eczema.” NCT02300701 ↗ “anti-IgE antibody, Xolair (omalizumab)” NCT00117611 ↗ “XolairTM (Omalizumab)” NCT00639691 ↗ “Omalizumab (Xolair®)” NCT07059091 ↗ “Omalizumab (Xolair®)” NCT04361812 ↗ “Omalizumab (Xolair®)” NCT01179529 ↗ “Xolair (omalizumab)” NCT00401596 ↗ “Xolair (omalizumab)” NCT00109200 ↗ “Omalizumab (Xolair)” NCT01803763 ↗ “Xolair (omalizumab)” NCT00109187 ↗ “Omalizumab (Xolair)” NCT00260702 ↗ “Omalizumab (Xolair)” NCT00851370 ↗ “Omalizumab (Xolair)” NCT00890162 ↗ “Xolair (omalizumab)” NCT00086606 ↗ “Omalizumab (Xolair)” NCT02049294 ↗ “omalizumab (Xolair)” NCT00286416 ↗ |
| Known as | Xolair(R) | “Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE.” NCT01393340 ↗ |
| Known as | XolairTM | “XolairTM (Omalizumab)” NCT00639691 ↗ |
| Action | Inhibit | “Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies.” NCT00078195 ↗ |
| Modality | Monoclonal antibody | “Omalizumab, a humanized monoclonal anti-IgE antibody” PMID 16387596 ↗ Dec 2005 |
| Route | Subcutaneous | “SC Omalizumab” NCT00046748 ↗ |