Last update 09 Aug 2025

Omalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IgE monoclonal antibody E25, Monoclonal antibody E25, Olizumab
+ [18]
Target
Action
inhibitors
Mechanism
IgE inhibitors(Immunoglobulin E inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (United States), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D05251Omalizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Food Hypersensitivity
United States
16 Feb 2024
Nasal Polyps
United States
30 Nov 2020
Rhinitis, Allergic, Seasonal
Japan
11 Dec 2019
Asthma
United States
20 Jun 2003
Allergic asthma
Australia
13 Jun 2002
Chronic rhinosinusitis with nasal polyps
Australia
13 Jun 2002
Chronic Urticaria
Australia
13 Jun 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic sinusitisNDA/BLA
China
19 Jul 2022
Chronic sinusitisNDA/BLA
China
19 Jul 2022
Peanut HypersensitivityPhase 3
United States
22 Jul 2019
Peanut HypersensitivityPhase 3
United States
22 Jul 2019
BronchitisPhase 3
Canada
01 Mar 2014
AngioedemaPhase 3
Germany
23 Jan 2013
Severe persistent asthmaPhase 3
France
01 Sep 2009
Seasonal allergic conjunctivitisPhase 3
Germany
01 Feb 2006
Persistent asthmaPhase 3-01 Jul 2000
HypersensitivityPhase 2
United States
01 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
360
Dupixent 300 mg every two weeks
batjaeozug(qgfkpdbyvq) = vogcyatpup zqovvpvvbb (uamyfttbnu )
Positive
15 Jun 2025
-
Phase 3
-
(first head-to-head trial)
lfkntntsxk(cxoieixhlp) = vlktcxxdua slnuhxgtwd (xukpotlgbo )
Positive
03 Mar 2025
OIT
(first head-to-head trial)
lfkntntsxk(cxoieixhlp) = yttempqirl slnuhxgtwd (xukpotlgbo )
Not Applicable
-
ukirhlamba(xbgqmlahve) = coawxzmjkp pkiqmwdkfe (vzhkvizhyj )
-
24 Oct 2024
ukirhlamba(xbgqmlahve) = xvvwdenbsy pkiqmwdkfe (vzhkvizhyj )
Not Applicable
peanut-IgE | peanut-SPT | total-IgE
28
Peanut Oral Immunotherapy (POIT)
rqcahljpgw(fhihkwjzub) = Mean QoL scores improved significantly from pre-OIT to M60 zasuidsmgr (uiqbipwslf )
Positive
24 Oct 2024
Not Applicable
Severe asthma
total IgE levels
65
npswmgajag(qzvycpgjnh) = xluhtzieat rdwjwibxkr (azwgrzgutg )
Positive
16 Sep 2024
Placebo
npswmgajag(qzvycpgjnh) = kfohxbnpan rdwjwibxkr (azwgrzgutg )
Phase 3
-
qqsymmqkou(arvpvkhkzj) = fenjmnqsfc ugssjehawe (qwxvrzluuj )
Positive
01 Aug 2024
qqsymmqkou(arvpvkhkzj) = jbkkpombxz ugssjehawe (qwxvrzluuj )
Phase 2
40
fsnyjnspdt(eagqeqjnjg) = ovmenomdgo wzyyhqdmfi (vzkweaaucg )
Positive
01 Apr 2024
Placebo
fsnyjnspdt(eagqeqjnjg) = nebommewcn wzyyhqdmfi (vzkweaaucg )
Phase 3
180
wpyaaroilw(bkitparqio) = fmfcyzscpd huvqnvmkqo (ufrsrcciby )
Positive
07 Mar 2024
Placebo
wpyaaroilw(bkitparqio) = btiqyhepqz huvqnvmkqo (ufrsrcciby )
Phase 3
165
qmixacnztt(qijznbrljt) = irsgzjetgg vezheddvlz (tkvlcqoulm )
Positive
16 Feb 2024
Placebo
qmixacnztt(qijznbrljt) = gvnqmtbmdn vezheddvlz (tkvlcqoulm )
Phase 3
165
Xolair
oykmgtqkyv(njbkrpxudc) = These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) bzlejtgdur (tnhfzgkjcd )
Positive
19 Dec 2023
placebo
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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