Omalizumab

also known as Xolair · CT-P39 · Omalizumab (Xolair) · Genolar · OMA · OMB · RhuMab-E25 · Xolair(R) · +1 more

Developed for: asthma · allergic asthma · food allergy · chronic idiopathic urticaria · chronic rhinosinusitis · chronic urticaria · nasal cavity polyp · atopic eczema
+35 more
· urticaria · allergic disease · 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
+82 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 · 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 · University of Florida · all 88 on the full record

Regulatory milestones approvals, filings & regulatory actions · 13 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed bronchiectasis and nasal polyposis 1 milestone
Filed	US (FDA)	Xolair	bronchiectasis and nasal polyposis	2019-12-10	“FDA Accepts Supplemental Biologics License Application for Xolair (Omalizumab) for the Treatment of Nasal Polyps” gene.com ↗
Filed food allergy 1 milestone
Filed	US (FDA)	Xolair	food allergy	2023-12-19	“the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab)” roche.com ↗ “FDA has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab)” gene.com ↗
Approved Indication not stated 4 milestones
Label expansions (8)	US (FDA)	XOLAIR	—	2010-01-04 – 2024-02-16	fda.gov ↗
Filed	US (FDA)	Xolair	asthma, chronic idiopathic urticaria	2020-08-12	“FDA accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved U.S. indications.” gene.com ↗ “Xolair FDA acceptance of filing Self-administration (home use) for the treatment of asthma” roche.com ↗ “Xolair File accepted in the US for self-administered prefilled syringe.” novartis.com ↗
Approved	EU (EMA)	Xolair	—	2005-10-25	europa.eu ↗
Approved	US (FDA)	XOLAIR	—	2003-06-20	fda.gov ↗

Trials 137 · started per year

today

US approved 2003

EU approved 2005

20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

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 Stop: Enrollment
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 Stop: Business
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 · 4 met primary · 2 missed
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	Missed primary
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	Met primary
Phase 2	NCT01599637	Apr 2012 → Sep 2013	chronic idiopathic urticaria	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01580592	Apr 2012 → Dec 2014	cold urticaria	Charite University, Berlin, Germany	Completed	Met primary
Phase 2	NCT01157117	Aug 2010 → Jan 2015	food allergy	Hugh A Sampson, MD	Completed	Missed primary
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	Met primary
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	Mixed
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	Met primary
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 · 1 met primary
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	Met primary
Phase 2/3	NCT00180011	Sep 2005 → Feb 2012	asthma	DiMango, Emily, M.D.	Completed	No outcome recorded
Phase 336 trials · 12 met primary
Phase 3	NCT07816328	Sep 2026 → Jun 2028 expected	chronic idiopathic urticaria	Novartis Pharmaceuticals	Recruiting	No outcome recorded
Phase 3	NCT05774639	Aug 2023 → Oct 2024	chronic idiopathic urticaria	Kashiv BioSciences, LLC	Completed	Met primary
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	Met primary
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	Met primary
Phase 3	NCT03280537	Nov 2017 → Mar 2019	chronic rhinosinusitis, nasal cavity polyp	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT03280550	Nov 2017 → Mar 2019	chronic rhinosinusitis, nasal cavity polyp	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT03328897	Apr 2017 → Jul 2019	chronic idiopathic urticaria	Novartis Pharmaceuticals	Completed	Met primary
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	Met primary
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	Met primary
Phase 3	NCT01292473	Mar 2011 → Jun 2012	chronic idiopathic urticaria	Genentech, Inc.	Completed	Met primary
Phase 3	NCT01328886	Mar 2011 → Dec 2013	allergic asthma	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01264939	Feb 2011 → Nov 2012	chronic idiopathic urticaria	Genentech, Inc.	Completed	No outcome recorded
Phase 3	NCT01287117	Feb 2011 → Oct 2012	chronic idiopathic urticaria	Genentech, Inc.	Completed	Met primary
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	Met primary
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	Met primary
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	NCT00829179	Oct 2002 → Jul 2004	allergic asthma	Duke University	Completed	No outcome recorded
Phase 3	NCT00232050	Oct 2002 → May 2005	asthma	Novartis	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 445 trials · 7 met primary
Phase 4	NCT07845552	Oct 2026 → Oct 2028 expected	food allergy	Johns Hopkins University	Not yet recruiting	No outcome recorded
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	Met primary
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	Met primary
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 Stop: Enrollment
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 Stop: Enrollment
Phase 4	NCT02392624	May 2015 → Mar 2017	urticaria	Genentech, Inc.	Completed	Met primary
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	Met primary
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	Mixed
Phase 4	NCT01125748	May 2010 → Aug 2013	allergic asthma	Genentech, Inc.	Completed	Met primary
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 Stop: Enrollment
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 Stop: Business
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	Met primary
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	Met primary
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 applicable9 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
—	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 Stop: Enrollment
—	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
Comparator or background therapy64 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 Stop: Business
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 1/2	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 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	Missed primary
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 Stop: Enrollment
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	Missed primary
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	Met primary
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	Missed primary
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 2/3	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 3	NCT06365879 Comparator	Jun 2024 → Jan 2026	chronic idiopathic urticaria	Taizhou Mabtech Pharmaceutical Co.,Ltd	Completed	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	Met primary
Phase 3	NCT03580369 Comparator	Oct 2018 → Jul 2021	chronic idiopathic urticaria	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT00396409 Background	Feb 2006 → Aug 2008	allergic asthma	Novartis Pharmaceuticals	Completed	No outcome recorded
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 overdue	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	Met primary
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
—	NCT05129033 Comparator	Nov 2021 → Jun 2023	allergic bronchopulmonary aspergillosis	Shanghai Zhongshan Hospital	Unknown	No outcome recorded

News releases announcing trial results or a regulatory action · 49

Date	Issuer	Release
2026-03-30	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory 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 ↗ The United States (U.S.) Food and Drug Administration (FDA) has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia®, and Teva’s applications for a proposed biosimilar candidate to Xolair® (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency (EMA).
2026-02-10	Regeneron Pharmaceuticals	Results Regeneron Highlights Expanding Immunology Portfolio and Pipeline at AAAAI, Showcasing Novel Approaches to Treating Allergy regeneron.com ↗ Dupilumab With Medium-Dose Inhaled Corticosteroids Versus Omalizumab With High-Dose Inhaled Corticosteroids Improves Clinical Outcomes In Patients With Coexisting Chronic Rhinosinusitis With Nasal Polyps And Uncontrolled Asthma
2025-12-03	Celltrion	Regulatory Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR® celltrion.com ↗ FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases
2025-11-18	Celltrion	Regulatory Celltrion Announces European Commission Approval of Additional Line Extension for Omlyclo™ 300mg celltrion.com ↗ The European Commission (EC) has granted a line extension in the European Union (EU) for Celltrion’s Omlyclo™ (omalizumab), Europe’s first and only omalizumab biosimilar, for the 300 mg/2ml prefilled syringe (PFS).
2025-10-06	Alvotech Swiss AG	Regulatory European Marketing Application for AVT23, a Proposed Biosimilar to Xolair® (omalizumab), Accepted by the European Medicines Agency alvotech.com ↗ The EMA’s acceptance of the marketing application for AVT23 marks an important milestone in our mission to expand access to high-quality, affordable biologic medicines for patients across Europe.
2025-10-06	Advanz Pharma	Regulatory European Marketing Application for AVT23, a Proposed Biosimilar to Xolair® (omalizumab), Accepted by the European Medicines Agency advanzpharma.com ↗ today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
2025-09-26	Impax Laboratories, LLC	Regulatory Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab) amneal.com ↗ Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR ® (omalizumab), developed by Kashiv BioSciences, LLC.
2025-06-25	Alvotech Swiss AG	Results Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗ The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic.
2025-06-25	Advanz Pharma	Results Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) advanzpharma.com ↗ The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic.
2025-06-15	Sanofi	Results 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 ↗ In the study, Dupixent (dupilumab) outperformed Xolair (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints.
2025-06-15	Regeneron Pharmaceuticals	Results 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 ↗ In the trial, Dupixent® (dupilumab) outperformed Xolair® (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints.
2025-03-26	Alvotech Swiss AG	Regulatory UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗
2025-03-26	Advanz Pharma	Regulatory UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab) advanzpharma.com ↗ the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab)
2025-03-10	Celltrion	Regulatory U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® celltrion.com ↗ The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40.
2025-03-03	Yuhan Corporation	Results 유한양행, 알레르기 질환 치료제 레시게르셉트(YH35324) 미국 알레르기천식 면역학회(AAAAI)서 만성 두드러기 환자 대상 임상 1b상 결과 발표 yuhan.co.kr ↗ 임상시험 결과, 레시게르셉트는 만성 자발성 두드러기 환자에서의 안전성과 오말리주맙 대비 더 강력하면서 지속적인 혈중 유리 IgE 억제 활성을 보여주었다.
2025-03-02	Hoffmann-La Roche	Results Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies roche.com ↗ The primary endpoint was tolerance of 2,000 mg or more for all three foods, which was met.
2025-03-02	Genentech, Inc.	Results Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies gene.com ↗ Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.
2025-02-10	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Regulatory VOLUNTARY ANNOUNCEMENT - NEW INDICATION FOR ENYITAN (OMALIZUMAB FOR INJECTION) OBTAINS MARKETING APPROVAL irasia.com ↗ It is the second approved indication for Enyitan ® in China.
2024-10-08	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Regulatory VOLUNTARY ANNOUNCEMENT - OMALIZUMAB FOR INJECTION OBTAINS MARKETING APPROVAL GRANTED BY NMPA irasia.com ↗ OMALIZUMAB FOR INJECTION OBTAINS MARKETING APPROVAL GRANTED BY NMPA
2024-05-24	Celltrion	Regulatory Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe celltrion.com ↗ Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.
2024-03-11	Celltrion	Regulatory Celltrion completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR® (omalizumab) celltrion.com ↗ Celltrion today announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar candidate to XOLAIR® (omalizumab) to the U.S. Food and Drug Administration (FDA).
2024-02-25	Hoffmann-La Roche	Results 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 ↗ The study showed treatment with Xolair increased the amount of peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as 1 year.
2024-02-25	Genentech, Inc.	Results New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies gene.com ↗ The study showed treatment with Xolair increased the amount of peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as 1 year.
2024-02-16	Hoffmann-La Roche	Regulatory FDA approves Xolair as first and only medicine for children and adults with one or more food allergies roche.com ↗ Basel, 16 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy.
2024-02-16	Genentech, Inc.	Regulatory FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.
2023-12-19	Hoffmann-La Roche	Regulatory 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 ↗
2023-12-19	Genentech, Inc.	Regulatory 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 gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with food allergy.
2023-06-26	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Regulatory VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTANCE OF BIOLOGIC LICENSE APPLICATION OF OMALIZUMAB FOR INJECTION irasia.com ↗ The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the biologic license application of Omalizumab for Injection (brand name: Kelingda (可令達)) (the “Product”) of CSPC Megalith Biopharmaceutical Co., Ltd* (石藥集團巨石生物製藥有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China.
2021-09-29	Novartis Pharmaceuticals	Results Novartis data show achieving complete control of chronic spontaneous urticaria (CSU) improves overall quality of life, as reported by patients novartis.com ↗ Complete control of CSU symptoms, assessed by a composite of patient reported outcomes (PROs), is more likely to be achieved and sustained with ligelizumab than Xolair ® (omalizumab) or placebo 2
2021-04-13	Hoffmann-La Roche	Regulatory FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications roche.com ↗
2021-04-12	Genentech, Inc.	Regulatory FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. indications.
2020-12-01	Hoffmann-La Roche	Regulatory FDA approves Xolair® (omalizumab) for adults with nasal polyps roche.com ↗ The FDA’s approval is based on results from the Phase III POLYP 1 and POLYP 2 trials.
2020-12-01	Genentech, Inc.	Regulatory Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps gene.com ↗ With this approval, Xolair is now the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation.
2020-08-12	Genentech, Inc.	Regulatory FDA Accepts Application for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across all Indications gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved U.S. indications.
2020-08-06	Novartis Pharmaceuticals	Regulatory Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps novartis.com ↗ EC approves Xolair ® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication
2020-06-26	Novartis Pharmaceuticals	Regulatory Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps novartis.com ↗
2020-01-09	Novartis Pharmaceuticals	Results Novartis ligelizumab (QGE031) more effective than Xolair® at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria novartis.com ↗ Novartis, a leader in immuno-dermatology, announced mechanistic study results showing ligelizumab is more effective at inhibiting the major pathogenic IgE/FcεRI pathway in chronic spontaneous urticaria (CSU), than current therapy Xolair ® (omalizumab) 1 .
2019-12-10	Genentech, Inc.	Regulatory FDA Accepts Supplemental Biologics License Application for Xolair (Omalizumab) for the Treatment of Nasal Polyps gene.com ↗ FDA Accepts Supplemental Biologics License Application for Xolair (Omalizumab) for the Treatment of Nasal Polyps
2019-10-08	Novartis Pharmaceuticals	Results Novartis data show more patients are completely symptom-free from chronic spontaneous urticaria with ligelizumab (QGE031) than Xolair® 300 mg novartis.com ↗ Results from a Phase IIb dose-finding study show an average complete response rate of 42% for doses 240 mg and 72 mg ligelizumab at Week 12 compared with 26% for those taking 300 mg Xolair’s dose (omalizumab)[1]
2019-06-03	Novartis Pharmaceuticals	Results Xolair® (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies novartis.com ↗ Novartis today announced positive topline data from two phase III, multicenter studies evaluating omalizumab (Xolair ® ) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard-of-care (intranasal corticosteroids).
2019-06-02	Genentech, Inc.	Results Xolair (omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults With Chronic Rhinosinusitis With Nasal Polyps in Two Phase III Studies gene.com ↗ The POLYP 1 and POLYP 2 Phase III trials met both co-primary endpoints and key secondary endpoints.
2018-12-13	Novartis Pharmaceuticals	Regulatory Novartis receives European Commission approval for self-administration of Xolair® across all indications novartis.com ↗ Novartis today announced that the European Commission (EC) has approved Xolair ® (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.
2018-09-28	Genentech, Inc.	Regulatory FDA Approves Genentech's Xolair (Omalizumab) Prefilled Syringe Formulation gene.com ↗ FDA Approves Genentech's Xolair (Omalizumab) Prefilled Syringe Formulation
2018-08-12	Genentech, Inc.	Regulatory FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.
2018-07-26	Glenmark Pharmaceuticals Ltd. India	Results Glenmark Pharmaceuticals Announces Encouraging Phase 1 Results Supporting Biosimilarity Criteria for GBR 310 Compared to the Reference Product Omalizumab glenmarkpharma.com ↗ Glenmark Pharmaceuticals Announces Encouraging Phase 1 Results Supporting Biosimilarity Criteria for GBR 310 Compared to the Reference Product Omalizumab
2017-09-16	Novartis Pharmaceuticals	Results Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption novartis.com ↗ Should a treatment pause be necessary, data showed almost 90% of chronic spontaneous urticaria (CSU) patients - previously well controlled - regained effective symptom control within 12 weeks of re-treatment on Xolair[2]
2016-07-07	Genentech, Inc.	Regulatory FDA Approves Genentech’s Xolair® (omalizumab) for Allergic Asthma in Children gene.com ↗ With this approval, we’re pleased to see a proven treatment option is now available for appropriate patients six and older.
2016-03-01	Genentech, Inc.	Regulatory FDA Files Genentech’s Supplemental Biologics License Application of Xolair® (omalizumab) for Pediatric Allergic Asthma gene.com ↗ The disease can significantly impact a child, and this filing acceptance brings us one step closer to addressing this significant unmet need.
2015-06-12	Novartis Pharmaceuticals	Results Novartis reports new analysis showing Xolair® improving quality of life by 78% for chronic spontaneous urticaria patients novartis.com ↗ New analysis from pivotal Phase III studies show Xolair ® (omalizumab) significantly improved quality of life scores for Chronic Spontaneous Urticaria (CSU) patients compared to placebo[1],[2]

All press releases naming this drug 58 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 ↗
2026-02-10	Regeneron Pharmaceuticals	Regeneron Highlights Expanding Immunology Portfolio and Pipeline at AAAAI, Showcasing Novel Approaches to Treating Allergy regeneron.com ↗
2025-12-03	Celltrion	Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR® celltrion.com ↗
2025-11-18	Celltrion	Celltrion Announces European Commission Approval of Additional Line Extension for Omlyclo™ 300mg celltrion.com ↗
2025-10-06	Alvotech Swiss AG	European Marketing Application for AVT23, a Proposed Biosimilar to Xolair® (omalizumab), Accepted by the European Medicines Agency alvotech.com ↗
2025-10-06	Advanz Pharma	European Marketing Application for AVT23, a Proposed Biosimilar to Xolair® (omalizumab), Accepted by the European Medicines Agency advanzpharma.com ↗
2025-09-26	Impax Laboratories, LLC	Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab) amneal.com ↗
2025-06-25	Alvotech Swiss AG	Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗
2025-06-25	Advanz Pharma	Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) advanzpharma.com ↗
2025-06-25	Impax Laboratories, LLC	Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences amneal.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 ↗
2025-03-26	Alvotech Swiss AG	UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗
2025-03-26	Advanz Pharma	UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab) advanzpharma.com ↗
2025-03-10	Celltrion	U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® celltrion.com ↗
2025-03-03	Yuhan Corporation	유한양행, 알레르기 질환 치료제 레시게르셉트(YH35324) 미국 알레르기천식 면역학회(AAAAI)서 만성 두드러기 환자 대상 임상 1b상 결과 발표 yuhan.co.kr ↗
2025-03-02	Hoffmann-La Roche	Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies roche.com ↗
2025-03-02	Genentech, Inc.	Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies gene.com ↗
2025-02-10	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	VOLUNTARY ANNOUNCEMENT - NEW INDICATION FOR ENYITAN (OMALIZUMAB FOR INJECTION) OBTAINS MARKETING APPROVAL irasia.com ↗
2024-10-08	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	VOLUNTARY ANNOUNCEMENT - OMALIZUMAB FOR INJECTION OBTAINS MARKETING APPROVAL GRANTED BY NMPA irasia.com ↗
2024-07-01	Impax Laboratories, LLC	Amneal Expands Biosimilars Portfolio to Eight Products with Addition of Omalizumab Biosimilar amneal.com ↗
2024-05-24	Celltrion	Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe celltrion.com ↗
2024-03-11	Celltrion	Celltrion completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR® (omalizumab) celltrion.com ↗
2024-02-25	Hoffmann-La Roche	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 ↗
2024-02-25	Genentech, Inc.	New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies gene.com ↗
2024-02-16	Hoffmann-La Roche	FDA approves Xolair as first and only medicine for children and adults with one or more food allergies roche.com ↗
2024-02-16	Genentech, Inc.	FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies gene.com ↗
2023-12-19	Hoffmann-La Roche	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 ↗
2023-12-19	Genentech, Inc.	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 gene.com ↗
2023-10-03	Alvotech Swiss AG	Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗
2023-06-26	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTANCE OF BIOLOGIC LICENSE APPLICATION OF OMALIZUMAB FOR INJECTION irasia.com ↗
2023-02-06	Alvotech Swiss AG	Alvotech enters into commercialization agreement with Advanz Pharma for proposed biosimilar to Xolair® (omalizumab) alvotech.com ↗
2023-02-06	Advanz Pharma	ADVANZ PHARMA enters into an exclusive agreement with Alvotech to commercialise a proposed biosimilar to Xolair® (omalizumab) advanzpharma.com ↗
2022-02-02	Alvotech Swiss AG	Alvotech Enters Exclusive Global Licensing Agreement with BiosanaPharma for Co-Development of a Proposed Biosimilar (AVT23) to Xolair® (Omalizumab) alvotech.com ↗
2021-09-29	Novartis Pharmaceuticals	Novartis data show achieving complete control of chronic spontaneous urticaria (CSU) improves overall quality of life, as reported by patients novartis.com ↗
2021-04-13	Hoffmann-La Roche	FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications roche.com ↗
2021-04-12	Genentech, Inc.	FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications gene.com ↗
2020-12-01	Hoffmann-La Roche	FDA approves Xolair® (omalizumab) for adults with nasal polyps roche.com ↗
2020-12-01	Genentech, Inc.	Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps gene.com ↗
2020-08-12	Genentech, Inc.	FDA Accepts Application for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across all Indications gene.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 ↗
2019-12-10	Genentech, Inc.	FDA Accepts Supplemental Biologics License Application for Xolair (Omalizumab) for the Treatment of Nasal Polyps gene.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 ↗
2019-06-02	Genentech, Inc.	Xolair (omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults With Chronic Rhinosinusitis With Nasal Polyps in Two Phase III Studies gene.com ↗
2018-12-13	Novartis Pharmaceuticals	Novartis receives European Commission approval for self-administration of Xolair® across all indications novartis.com ↗
2018-09-28	Genentech, Inc.	FDA Approves Genentech's Xolair (Omalizumab) Prefilled Syringe Formulation gene.com ↗
2018-08-12	Genentech, Inc.	FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies gene.com ↗
2018-07-26	Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals Announces Encouraging Phase 1 Results Supporting Biosimilarity Criteria for GBR 310 Compared to the Reference Product Omalizumab glenmarkpharma.com ↗
2018-03-06	Novartis Pharmaceuticals	Novartis' Xolair® recommended in new global chronic urticaria guideline novartis.com ↗
2018-03-05	GlaxoSmithKline	Nucala (mepolizumab) improved asthma control in patients uncontrolled on Xolair (omalizumab) gsk.com ↗
2017-09-16	Novartis Pharmaceuticals	Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption novartis.com ↗
2016-07-07	Genentech, Inc.	FDA Approves Genentech’s Xolair® (omalizumab) for Allergic Asthma in Children gene.com ↗
2016-03-01	Genentech, Inc.	FDA Files Genentech’s Supplemental Biologics License Application of Xolair® (omalizumab) for Pediatric Allergic Asthma gene.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 13 cited values

Every value below carries the sentence it was read from. 202 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 ↗ 189 “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 ↗ Show 179 more sources
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)” NCT00691873 ↗ 1 “Omalizumab (Xolair)” NCT00329381 ↗
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 ↗ 49 “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 ↗ Show 39 more sources
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 ↗