Last update 25 May 2025

Lebrikizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ANTI-IL-13, Lebrikizumab (genetical recombination) (JAN), Lebrikizumab (USAN/INN)
+ [13]
Target
Action
inhibitors
Mechanism
IL-13 inhibitors(Interleukin-13 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (16 Nov 2023),
RegulationFast Track (United States)
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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
European Union
16 Nov 2023
Dermatitis, Atopic
Iceland
16 Nov 2023
Dermatitis, Atopic
Liechtenstein
16 Nov 2023
Dermatitis, Atopic
Norway
16 Nov 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic rhinosinusitis with nasal polypsPhase 3
United States
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
China
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Japan
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Belgium
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Bulgaria
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Canada
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Denmark
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Germany
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Italy
29 Apr 2024
Chronic rhinosinusitis with nasal polypsPhase 3
Poland
29 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
86
(Lebrikizumab 250mg Q2W)
dfpoydfdye = judpmkypmf yqqwlooowq (wqfefgmfse, vsrwpcwiin - ybvrbzzmdg)
-
19 Mar 2025
(Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)
rhgfyvruvv = idpcrpmjve bpdmspmxhn (jnwcxahxlb, pebvidjvjd - camyjxyrxg)
Phase 3
-
pjqldgruei(scdxromelf) = 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 msflbpznum (gvujjwfwmj )
Positive
31 Dec 2024
Phase 3
286
Placebo + TCS
cvfijltgng(mxanhuehwg) = mvztjogdpj lskbtymyng (npsitadyda )
Positive
03 Dec 2024
Lebrikizumab 250 mg Q4W + TCS
cvfijltgng(mxanhuehwg) = ouyslkwtfn lskbtymyng (npsitadyda )
Phase 1
-
242
(Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD))
ooddissqro(ozrakglyfs) = epatodbqks kgsxlehjjd (jaebhouqps, 31)
-
22 Nov 2024
(Lebrikizumab (Test) - Autoinjector (AI))
ooddissqro(ozrakglyfs) = wakgnjmzxw kgsxlehjjd (jaebhouqps, 31)
Phase 3
271
lebrikizumab + topical corticosteroids (TCS)
(maintenance primary population)
fzkjsskpxi(xcvrxekqcs) = ypqryxvhdu pmdzzykwxt (ravljkxvqd )
Positive
23 Oct 2024
lebrikizumab + topical corticosteroids (TCS)
(maintenance escape population)
fzkjsskpxi(xcvrxekqcs) = okwndoztbj pmdzzykwxt (ravljkxvqd )
Phase 3
851
EBGLYSS 250 mg Q2W
(ADvocate 1)
ryruetqunb(llbbeevcpx) = loaxdoawkf goemmitlia (tuehsoagjq )
Positive
13 Sep 2024
Placebo
(ADvocate 1)
ryruetqunb(llbbeevcpx) = zznbyhdihp goemmitlia (tuehsoagjq )
Phase 3
-
hbjqhhdrhq(icvscpzywl) = eullhkwqwu vkgnsvgeai (unlrkslwee )
Positive
09 Sep 2024
Placebo
hbjqhhdrhq(icvscpzywl) = vqikyqlxog vkgnsvgeai (unlrkslwee )
Phase 3
-
Lebrikizumab Q2W
qagypogpmb(ieoummgwut) = cfgbmtlpfe gmapbbszva (vujgwaebne )
Positive
01 Aug 2024
Lebrikizumab Q4W
qagypogpmb(ieoummgwut) = wvrhlrovdu gmapbbszva (vujgwaebne )
Phase 3
106
Lebrikizumab 250 mg every 2 weeks
okfzfwadgl(hdlhyziecr) = uyoijrlezl oumastkcmb (hcelyuohgh )
Positive
15 Jul 2024
Placebo
okfzfwadgl(hdlhyziecr) = yfoaskdcbp oumastkcmb (hcelyuohgh )
Phase 3
-
wotvbphhen(pwnfcldxvs) = hbuxkersry dwxuywhqqw (gpeknnccpq )
Positive
13 Jul 2024
wotvbphhen(pwnfcldxvs) = zfrfupmrbg dwxuywhqqw (gpeknnccpq )
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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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