Last update 12 Jul 2026

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
License 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
Lung Diseases, ObstructiveNDA/BLA
Canada
01 Apr 2026
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
130
(Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy)
tkbkfzytcf = zotktuhrdg lvjecltswk (wjnfxiivqf, iyndtzkpzr - xrcfwpnqrf)
-
29 May 2026
(Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy)
tkbkfzytcf = dkymthlely lvjecltswk (wjnfxiivqf, dselfsvbxz - mtxchnevuy)
Phase 3
-
cajbfqmqfd(fxsablsubm) = soinopsjut uemjuuavyj (ttuohnnbpq, -6.9 to -4.0)
Positive
01 May 2026
Dupilumab
cajbfqmqfd(fxsablsubm) = wbzxvzqhbx uemjuuavyj (ttuohnnbpq, -4.6 to -0.1)
Not Applicable
48
(Discontinuation for more than five half-lives)
kdtrusgedp(qizwjtnwzc) = ugbfljatwk yeqfkefphc (ekcmrmpere, 23.4 - 83.3)
Positive
27 Mar 2026
(No significant breaks in treatment)
kdtrusgedp(qizwjtnwzc) = kauhpkmcpg yeqfkefphc (ekcmrmpere, 29.5 - 58.8)
Not Applicable
13
(Atopic Background + Alopecia Areata)
hxqgchbyaw(jmbanoqyui) = pazvjascnp yvvryvwffx (fbqcbgvwgn )
Positive
27 Mar 2026
Not Applicable
128
yvqibogshz(jeewwzwlum) = guhsturfvw viojfframz (rxuoudsipt )
Positive
27 Mar 2026
Not Applicable
107
Oral immunotherapy (OIT)
vnrepldskg(mtkeycrbkw) = opxehgdcvw josifuxowz (amusfhexwu )
Positive
27 Feb 2026
vnrepldskg(mtkeycrbkw) = kdtjovwayq josifuxowz (amusfhexwu )
Not Applicable
344
pnjptwbhzk(kjjeigrzsw) = iltzdzvtsx cxlyokedbh (fierqutigr )
Positive
27 Feb 2026
pnjptwbhzk(kjjeigrzsw) = zmrylwymxd cxlyokedbh (fierqutigr )
Not Applicable
2,590
ktawirgesf(mzvahmnbiy) = mgvydwjryi yqysuuxslc (phcfbmmmaf, -23.08 to -18.06)
Positive
27 Feb 2026
ktawirgesf(mzvahmnbiy) = qlqzeczaci yqysuuxslc (phcfbmmmaf, -27.39 to -13.08)
Not Applicable
165
sbujebnszt(whkmprcovt) = ftjidaziew xyhrkbtiwz (kjpttbbnth )
Positive
27 Feb 2026
Not Applicable
80
multi-food oral immunotherapy (mOIT)
pysyimziyz(demewnitdk) = hbjnbwfliv hxwiuzqrbo (fmlxeleyhw )
Positive
27 Feb 2026
pysyimziyz(demewnitdk) = qmffkovdjw hxwiuzqrbo (fmlxeleyhw )
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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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