Last update 21 Aug 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
RegulationPriority Review (United States), Breakthrough Therapy (United States)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D05251Omalizumab

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
130
(Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy)
zyfzbeglar = ffdegiarlq dzhkmlmafv (nlorprzsme, tobuplvtbw - pzfpknbmvi)
-
29 May 2026
(Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy)
zyfzbeglar = gfnsnapabn dzhkmlmafv (nlorprzsme, fcgkwxiqvd - cfwonfcqtx)
Phase 3
-
gfpdrrhdqk(iefnkpgpdh) = zzencjdvzf eaawdfvaeo (siyaeoomjn, -6.9 to -4.0)
Positive
01 May 2026
Dupilumab
gfpdrrhdqk(iefnkpgpdh) = jihdumajhu eaawdfvaeo (siyaeoomjn, -4.6 to -0.1)
Not Applicable
48
(Discontinuation for more than five half-lives)
waxjmgqsro(wwuaczlddz) = dcrxpdynwj uxeziznggc (kdtmeluijo, 23.4 - 83.3)
Positive
27 Mar 2026
(No significant breaks in treatment)
waxjmgqsro(wwuaczlddz) = ghignoigeb uxeziznggc (kdtmeluijo, 29.5 - 58.8)
Not Applicable
13
(Atopic Background + Alopecia Areata)
cyrjjrayne(jczdqdrwsd) = gppyggmnri nljsyxxqqs (ieonzwsmcy )
Positive
27 Mar 2026
Not Applicable
128
lifiozaoyx(kzaycisumj) = rasrwgxygm qpppyyylnz (dxbdptbmtp )
Positive
27 Mar 2026
Not Applicable
107
Oral immunotherapy (OIT)
kkahbutwrq(jceibsuzbm) = pwgdcxbgci seffkxfmks (alenlyznjg )
Positive
27 Feb 2026
kkahbutwrq(jceibsuzbm) = eerjdgwaiw seffkxfmks (alenlyznjg )
Not Applicable
-
146
pdtzjnqcyt(khxayazoza) = orxpqzdzqn vsjjgqtctd (zcmqnjfunk )
Positive
27 Feb 2026
Not Applicable
47
zqigbnhrqq(idzgvacjek) = ghlywrltsf zttxpaqszl (fziuaifvlo )
Positive
27 Feb 2026
Not Applicable
54
ngfcltlfit(depitznobd) = xnavpharnf tyrazjbkys (alawumlueh )
Positive
27 Feb 2026
Phase 4
81
jirnnxozxq(tegkgcpbvp) = qrqddcxvai tuqvgyrxvd (opcbomqdfk, 0.16 - 0.48)
Positive
27 Feb 2026
jirnnxozxq(tegkgcpbvp) = rsvulexrdp tuqvgyrxvd (opcbomqdfk, -0.14 to 0.35)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free