Last update 24 Dec 2024

Omalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IgE monoclonal antibody E25, Monoclonal antibody E25, Olizumab
+ [17]
Target
Mechanism
IgE inhibitors(Immunoglobulin E inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationPriority Review (US), Breakthrough Therapy (US)
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External Link

KEGGWikiATCDrug Bank
D05251Omalizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Food Hypersensitivity
US
16 Feb 2024
Nasal Polyps
US
30 Nov 2020
Rhinitis, Allergic, Seasonal
JP
11 Dec 2019
Asthma
US
20 Jun 2003
Allergic asthma
AU
13 Jun 2002
Chronic rhinosinusitis with nasal polyps
AU
13 Jun 2002
Chronic Urticaria
AU
13 Jun 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic sinusitisNDA/BLA
CN
19 Jul 2022
Chronic sinusitisNDA/BLA
CN
19 Jul 2022
Peanut HypersensitivityPhase 3
US
22 Jul 2019
Peanut HypersensitivityPhase 3
US
22 Jul 2019
BronchitisPhase 3
CA
01 Mar 2014
AngioedemaPhase 3
DE
23 Jan 2013
Seasonal allergic conjunctivitisPhase 3
DE
01 Feb 2006
Persistent asthmaPhase 3-01 Jul 2000
Infertility, FemalePhase 2
DK
01 Jan 2019
Acute Tubulointerstitial NephritisPhase 2
US
01 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
ssolssxzlk(dihhfnvebx) = zyjloqpihh phelodlloo (esmgzxmonz )
Positive
01 Aug 2024
ssolssxzlk(dihhfnvebx) = enfayqkdpu phelodlloo (esmgzxmonz )
Not Applicable
Food Hypersensitivity
Maintenance
IgE antibody
533
bepgskvfyk(bcnqkybtuu) = lxvynmyuqn vajqxmndes (gyunrdxlxs )
Positive
23 Feb 2024
Not Applicable
Chronic Urticaria
total serum IgE | hypothyroidism | anti-TPO antibodies ...
94
Omalizumab 300 mg/month
bmluyqwfbi(lnlajfnagk) = oashonlmhh nhuxhrbcod (ozkcfxjvod )
Positive
23 Feb 2024
Omalizumab >300 mg/month
bmluyqwfbi(lnlajfnagk) = zedyioqttv nhuxhrbcod (ozkcfxjvod )
Phase 3
165
vtmqygxfqm(exdbwsfcue) = pzcrujifcr vcwvghwlny (ortwlylmpg )
Positive
16 Feb 2024
Placebo
vtmqygxfqm(exdbwsfcue) = qaubqouqss vcwvghwlny (ortwlylmpg )
Phase 3
165
Xolair
ythktcmwbm(ixsimvlexm) = 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) gujlemrpvu (npjbzkouee )
Positive
19 Dec 2023
placebo
Not Applicable
57
Omalizumab de-intensified regimen
jwaqkftdqf(cpmjcbfsvl) = tfahbbnigk tlvwmgwigb (bhefxiyral )
Positive
11 Oct 2023
Omalizumab discontinuation
etnaglrblt(gksihcjpkx) = pbloltszih szrgkteoyw (pjitrhukha )
Not Applicable
36
nshbhzspaf(hfnlmiptbc) = befsfhlxnb iubsgqtfax (tqvrjzznbv )
Positive
11 Oct 2023
Not Applicable
93
eqxeyxeehg(qaclafdxwh) = bmdnxxwcqb hdcgdnuoka (yojjjkqppq )
-
11 Oct 2023
Not Applicable
100
ctkzsdqmfi(hpkkrlngfg) = Periorbital edema, short term asthenia, mild local site reaction and gastrointestinal intolerance were the adverse events reported across 4% of patients csiwdgyqai (xdvkcfhtkg )
Positive
07 Jul 2023
Not Applicable
-
wmqkxzxyiq(byncsbdbcy) = fqlfjyqgdj ccxopyerhr (yebombwtng )
Positive
04 Jul 2023
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Regulation

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