Drugs / Omalizumab
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Omalizumab

also known as Xolair · CT-P39 · Omalizumab (Xolair) · anti-IgE · Genolar · OMA · OMB · RhuMab-E25 · +2 more

Monoclonal antibody

Developed for
asthma · allergic asthma · food allergy · chronic idiopathic urticaria · chronic rhinosinusitis · chronic urticaria · nasal cavity polyp · allergic disease
+35 more · atopic eczema · urticaria · allergic rhinitis · seasonal allergic rhinitis · atopic IgE-mediated allergic disorder · bullous pemphigoid · allergic bronchopulmonary aspergillosis · angioedema · autism spectrum disorder · childhood onset asthma · chronic obstructive pulmonary disease · cold urticaria · COVID-19 · drug allergy · eosinophil disorder · eosinophilic esophagitis · esophagitis · gastroenteritis · hyper-IgE syndrome · immune system disorder · insect Stings, hypersensitivity to · interstitial cystitis · lung disorder · mastocytosis · sinusitis · solar urticaria · venom allergy · acute tubulointerstitial nephritis · aspirin-induced respiratory disease · cholinergic urticaria · chronic bronchitis · chronic inducible urticaria · female infertility · idiopathic anaphylaxis · systemic lupus erythematosus
Investigated by
Genentech, Inc. · Novartis Pharmaceuticals · Novartis · National Institute of Allergy and Infectious Diseases (NIAID) · Johns Hopkins University · Stanford University
+83 more · Creighton University · Hoffmann-La Roche · Tanox · University of Mississippi Medical Center · Beijing Tongren Hospital · Boston Children's Hospital · Charite University, Berlin, Germany · Daiichi Sankyo · Inner-City Asthma Consortium · Kashiv BioSciences, LLC · King's College London · Taizhou Mabtech Pharmaceutical Co.,Ltd · University of California, Davis · University of Colorado, Denver · AAADRS Clinical Research Center · AO GENERIUM · Ann & Robert H Lurie Children's Hospital of Chicago · Asthma Inc Clinical Research Center · Beijing Hospital · Bernstein Clinical Research Center · Beth Israel Deaconess Medical Center · COD Research Private Ltd · Caroline Nilsson · Carsten Bindslev-Jensen · Celltrion · Centre Hospitalier Universitaire de Besancon · Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Children's Hospital of Philadelphia · Children's Hospital of The King's Daughters · Children's National Research Institute · CuraTeQ Biologics Private Ltd. · Dana-Farber Cancer Institute · DiMango, Emily, M.D. · Duke University · Excellergy Inc. · Fondazione IRCCS Policlinico San Matteo di Pavia · Food Allergy Research & Education · Guy's and St Thomas' NHS Foundation Trust · Harvard School of Public Health (HSPH) · Hugh A Sampson, MD · IRCCS San Raffaele · Immune Tolerance Network (ITN) · Instituto de Investigação em Imunologia · Lynda Schneider · McGill University Health Centre/Research Institute of the McGill University Health Centre · Medical University of Vienna · Miltenyi Biomedicine GmbH · NYU Langone Health · National Heart, Lung, and Blood Institute (NHLBI) · National Institute for Health Research, United Kingdom · National Institutes of Health (NIH) · National Jewish Health · National Taiwan University Hospital · O & O Alpan LLC · Peking Union Medical College Hospital · Philippe Bégin · Rabin Medical Center · Regeneron Pharmaceuticals · Rho Federal Systems Division, Inc. · Sanofi · Scarlata, Simone, M.D. · Scripps Clinic · Shanghai Zhangjiang Biotechnology Limited Company · Shiraz University of Medical Sciences · Syneos Health · Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Technical University of Munich · Teva Pharmaceuticals Development, Inc. · Teva Pharmaceuticals USA · The Hospital for Sick Children · The University Clinic of Pulmonary and Allergic Diseases Golnik · University of California, Los Angeles · University of California, San Francisco · University of Chicago · all 89 on the full record

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

today
US approved 2003
EU approved 2005
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2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 1/22 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 2/34 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 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 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
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 1/23 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 2/32 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 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 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

DateIssuerRelease
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

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 201 sources stand behind the page.

FieldValueCited 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

OmalizumabNCT02300701

NCT02392624

NCT00870584

NCT00314574

NCT00670930

NCT00932282

NCT04195958

NCT06103656

NCT00096954

NCT01125748

NCT00657891

NCT01113437

NCT05061524

NCT00109200

NCT00267202

NCT00396409

NCT00219323

NCT01893658

NCT01393340

NCT07356713

NCT02626611

NCT02169115

NCT00109187

NCT00604786

NCT00123630

NCT04045301

NCT03580369

NCT02191072

NCT06027073

NCT03580356

NCT00866788

NCT04720612

NCT00078195

NCT02329223

NCT06618963

NCT01580592

NCT00180011

NCT00482248

NCT00226200

NCT05564221

NCT00495612

NCT02262130

NCT00382148

NCT01803763

NCT06228560

NCT03881696

NCT05960708

NCT01723072

NCT02023151

NCT01922037

NCT01976208

NCT04778137

NCT00232050

NCT01264939

NCT00472030

NCT04943744

NCT00242359

NCT00130234

NCT00639691

NCT00787917

NCT01040598

NCT05813470

NCT00555971

NCT04489121

NCT00454051

NCT02161562

NCT00133042

NCT00208234

NCT00377572

NCT03181009

NCT05564611

NCT05405478

NCT04998604

NCT07342803

NCT02550106

NCT05053334

NCT03727971

NCT01328886

NCT07059091

NCT01703312

NCT01716754

NCT01713725

NCT00968110

NCT00079937

NCT02118987

NCT02658877

NCT03369704

NCT02879006

NCT06943534

NCT04833855

NCT06934200

NCT01157117

NCT00162773

NCT01716312

NCT05449535

NCT00481676

NCT01066104

NCT05774639

NCT00086606

NCT03478930

NCT02570984

NCT00117611

NCT02966314

NCT02402231

NCT06437171

NCT03679676

NCT02049294

NCT04361812

NCT04583501

NCT06042478

NCT01544348

NCT00084097

NCT01294878

NCT00434434

NCT01781637

NCT00949078

NCT04037176

NCT04535817

NCT00482508

NCT02388997

NCT01912872

NCT04944602

NCT00286416

NCT00287378

NCT02654145

NCT03328897

NCT02968394

NCT01701583

NCT06509334

NCT05390255

NCT00822783

NCT00546143

NCT03111628

NCT04128176

NCT00851370

NCT06438757

NCT04601389

NCT01003301

NCT00401596

NCT03964051

NCT01179529

NCT01287117

NCT01007149

NCT00890162

NCT01202903

NCT00500539

NCT01510626

NCT02742805

NCT00046748

NCT03476109

NCT01584687

NCT00264849

NCT01155700

NCT01292473

NCT02477332

NCT06806826

NCT01678092

NCT01290913

NCT05129033

NCT00567476

NCT03280537

NCT00260702

NCT05332067

NCT00367016

NCT04585997

NCT03280550

NCT05916937

NCT04774315

NCT01430403

NCT02266355

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
1

NCT04426890

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

NCT00283504

NCT02814630

NCT04426890

NCT00673218

NCT00189228

NCT00624832

NCT02643862

NCT06365879

NCT00603785

NCT07246252

NCT04976192

NCT00329381

NCT00139152

NCT04601389

NCT05413161

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