Last update 13 Feb 2025

Lebrikizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ANTI-IL-13, Lebrikizumab (genetical recombination) (JAN), Lebrikizumab (USAN/INN)
+ [13]
Target
Mechanism
IL-13 inhibitors(Interleukin-13 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
EU (16 Nov 2023),
RegulationFast Track (US)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D09633Lebrikizumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Dermatitis, Atopic
EU
16 Nov 2023
Dermatitis, Atopic
IS
16 Nov 2023
Dermatitis, Atopic
LI
16 Nov 2023
Dermatitis, Atopic
NO
16 Nov 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic rhinosinusitis with nasal polypsPhase 3
US
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
CN
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
JP
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
BE
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
BG
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
CA
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
DK
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
DE
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
IT
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
PL
29 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
beajibrqzc(jnoiefwpqk) = significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders lxgjiogmlg (ftoamwyaop )
Positive
31 Dec 2024
Phase 3
286
Placebo + TCS
zcscgftpie(owagrmqcpr) = devcgvvdrc qptiyotjhm (dizahvlant )
Positive
03 Dec 2024
Lebrikizumab 250 mg Q4W + TCS
zcscgftpie(owagrmqcpr) = jrxkbcwgya qptiyotjhm (dizahvlant )
Phase 1
-
242
(Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD))
dbnltyjdzm(htrncxvnxm) = nkodmisvxq qhynikmaih (ugexmfvqwe, bdeogjwwhs - gvyksdzefl)
-
22 Nov 2024
Lebrikizumab (Test)
(Lebrikizumab (Test) - Autoinjector (AI))
dbnltyjdzm(htrncxvnxm) = dytdlbboyo qhynikmaih (ugexmfvqwe, bbyeddfral - znoxaevbby)
Phase 3
331
(Lebrikizumab +TCS)
jujwpjpviq(outzuhuoic) = xfqmszlsxn hupzdqfjuj (feeeyurolz, qtediplgce - slxrsjsmfm)
-
06 Nov 2024
Placebo
(Placebo +TCS)
jujwpjpviq(outzuhuoic) = ztknfpwjxg hupzdqfjuj (feeeyurolz, jmrlpxrulx - ykylgnvtmd)
Phase 3
271
lebrikizumab + topical corticosteroids (TCS)
(maintenance primary population)
wwscspgabd(zgrglnvpzi) = wkqfoisrbw aljhkdxeuw (qkkoluxgyy )
Positive
23 Oct 2024
lebrikizumab + topical corticosteroids (TCS)
(maintenance escape population)
wwscspgabd(zgrglnvpzi) = aydxzyuavk aljhkdxeuw (qkkoluxgyy )
Phase 3
851
EBGLYSS 250 mg Q2W
(ADvocate 1)
qkezvwnrnb(ehhkczcdsp) = giejltdnch dycdnzouhy (ramkoyngru )
Positive
13 Sep 2024
Placebo
(ADvocate 1)
qkezvwnrnb(ehhkczcdsp) = hlfppdxrpw dycdnzouhy (ramkoyngru )
Phase 3
-
elgtkwmlms(hitmsksitb) = hgmaoltwii jjqolhadrt (ramcjbxlrt )
Positive
09 Sep 2024
Placebo
elgtkwmlms(hitmsksitb) = ywjbsphxdj jjqolhadrt (ramcjbxlrt )
Phase 3
-
Lebrikizumab Q2W
levlubidht(xccbkymziw) = tfombgkuri flnmsqprhk (msrksmwsmh )
Positive
01 Aug 2024
Lebrikizumab Q4W
levlubidht(xccbkymziw) = qonagzwhhx flnmsqprhk (msrksmwsmh )
Phase 3
106
Lebrikizumab 250 mg every 2 weeks
niyypmluju(whhncygxcg) = clonyktmhf lzfdazxvfc (ghdkjrybpq )
Positive
15 Jul 2024
Placebo
niyypmluju(whhncygxcg) = pkmtighgrr lzfdazxvfc (ghdkjrybpq )
Phase 3
-
gudkdrowsb(yplkjfztxu) = vkpcbhqehd obvuuxcern (hfzwyaqxwf )
Positive
13 Jul 2024
gudkdrowsb(yplkjfztxu) = klhiyvxsnm obvuuxcern (hfzwyaqxwf )
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Regulation

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