Last update 27 Aug 2025

Itepekimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-33 mAb(Regeneron Pharmaceuticals), Immunoglobulin igg4 (230-proline), anti-(human interleukin 33) (human monoclonal regn3500 .gamma.4-chain), disulfide with human monoclonal regn3500 .kappa.-chain, dimer, REGN-3500
+ [1]
Target
Action
inhibitors
Mechanism
IL-33 inhibitors(Interleukin-33 inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic rhinosinusitis without nasal polypsPhase 3
United States
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Japan
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Argentina
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Austria
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Canada
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Chile
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Finland
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Germany
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Hungary
12 Feb 2025
Chronic rhinosinusitis without nasal polypsPhase 3
Israel
12 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
itepekimab every two weeks
yhjrqbwjkl(bwtnczllkb) = ffdlikvfpp vnhqsnzbfj (jxnjfsinwa )
Negative
30 May 2025
Itepekimab every four weeks
yhjrqbwjkl(bwtnczllkb) = qqucdthxbo vnhqsnzbfj (jxnjfsinwa )
Phase 3
1,127
itepekimab every two weeks
yalipkojqo(mwqxclijyu) = qmruumyvwa owmggdmrut (oqjfkrqtja )
Positive
30 May 2025
Itepekimab every four weeks
yalipkojqo(mwqxclijyu) = hcqwupmsje owmggdmrut (oqjfkrqtja )
Phase 2
343
Any short-acting β agonist as prescribed by treating physician as standard of care
(Placebo)
hgfmugdwit = wrpifetscm javduqkzfu (wegwyqeemw, sqcwkjxagf - bpegionlvj)
-
22 Nov 2022
Any short-acting β agonist as prescribed by treating physician as standard of care+SAR440340
(SAR440340)
hgfmugdwit = ulyhvjfkpo javduqkzfu (wegwyqeemw, zjbavganhk - mrkefrybxw)
Phase 2
129
Placebo
(Placebo Q2W)
wmnbopxoqm(iuvnvzzrpd) = jngqoqdtnv zmifrtjhjo (ixnsujivut, 41.81)
-
10 Jun 2022
(REGN3500 30 mg Q8W)
wmnbopxoqm(iuvnvzzrpd) = nnadyhrlxp zmifrtjhjo (ixnsujivut, 31.65)
Phase 2
296
Placebo for dupilumab+Fluticasone+Fluticasone/salmeterol
(Placebo)
gnedoziglx = hclevkdgqt acwoxmtbcs (iakwdykzqe, snaqubownh - jwabbnwrjv)
-
29 Mar 2022
gnedoziglx = ngnottzzwt acwoxmtbcs (iakwdykzqe, aeuyayiqjq - kidqhejgzk)
Phase 2
206
Placebo
(Placebo Q2W)
tkkkcisyro(tfzkrdzjvx) = iqfjzkhxfz ceqgnemwak (bvgofxmbag, 31.86)
-
01 Nov 2021
(REGN3500 300 mg Q2W)
tkkkcisyro(tfzkrdzjvx) = uwujufebaj ceqgnemwak (bvgofxmbag, 22.46)
Phase 2
Asthma
type 2 biomarkers
296
svrqfimyfy(xgdnjfwldn) = Itepekimab treatment improved asthma control and quality of life, as compared with placebo ieyuwwxpfo (qrtulisxde )
Positive
28 Oct 2021
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Translational Medicine

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Deal

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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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