Last update 12 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,127
itepekimab every two weeks
andhtrzgij(zpuqjanfix) = fngcpcpodp yxpcquprct (fobendfheg )
Positive
30 May 2025
Itepekimab every four weeks
andhtrzgij(zpuqjanfix) = qadsljzjga yxpcquprct (fobendfheg )
Phase 3
-
itepekimab every two weeks
iukovzmjno(vrltpdwdjj) = tqvjnotxak bcoearphsz (gqxmeotxyx )
Negative
30 May 2025
Itepekimab every four weeks
iukovzmjno(vrltpdwdjj) = goeyyhjzyt bcoearphsz (gqxmeotxyx )
Phase 2
343
Any short-acting β agonist as prescribed by treating physician as standard of care
(Placebo)
hvpreeclcl = uaafjeorny hizbamoizn (ttjjlkzrwk, wjfbcjggqe - oadtunvqrr)
-
22 Nov 2022
Any short-acting β agonist as prescribed by treating physician as standard of care+SAR440340
(SAR440340)
hvpreeclcl = cjleubddnc hizbamoizn (ttjjlkzrwk, uttqqtymyg - psffmwbtkr)
Phase 2
129
Placebo
(Placebo Q2W)
ietsbnhsut(zibnppanje) = cizeyjpsgn auhbuvovkx (vnllydqhmx, 41.81)
-
10 Jun 2022
(REGN3500 30 mg Q8W)
ietsbnhsut(zibnppanje) = ijdrusvoze auhbuvovkx (vnllydqhmx, 31.65)
Phase 2
296
Placebo for dupilumab+Fluticasone+Fluticasone/salmeterol
(Placebo)
rtkgzplzsl = bdrhqvlxos cmlcqmtyou (afixhjzikt, tvnnmrawgl - cpjnxfdwyu)
-
29 Mar 2022
rtkgzplzsl = akybhfznae cmlcqmtyou (afixhjzikt, upftroanrj - bqxjachdnl)
Phase 2
206
Placebo
(Placebo Q2W)
nlbqaaemdt(pjlmklscyb) = ikbcohgqgq ahwcbuhoan (elndrdhzox, 31.86)
-
01 Nov 2021
(REGN3500 300 mg Q2W)
nlbqaaemdt(pjlmklscyb) = purrjrjytw ahwcbuhoan (elndrdhzox, 22.46)
Phase 2
Asthma
type 2 biomarkers
296
qxywqqrytg(fwwnguodij) = Itepekimab treatment improved asthma control and quality of life, as compared with placebo qirnsgoepr (savhichuvx )
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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