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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (16 Nov 2023), |
RegulationFast Track (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09633 | Lebrikizumab | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic rhinosinusitis with nasal polyps | Phase 3 | United States | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | China | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Japan | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Belgium | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Bulgaria | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Canada | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Denmark | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Germany | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Italy | 29 Apr 2024 | |
Chronic rhinosinusitis with nasal polyps | Phase 3 | Poland | 29 Apr 2024 |
Phase 3 | 86 | (Lebrikizumab 250mg Q2W) | dfpoydfdye = judpmkypmf yqqwlooowq (wqfefgmfse, vsrwpcwiin - ybvrbzzmdg) View more | - | 19 Mar 2025 | ||
(Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W) | rhgfyvruvv = idpcrpmjve bpdmspmxhn (jnwcxahxlb, pebvidjvjd - camyjxyrxg) View more | ||||||
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 ) View more | Positive | 03 Dec 2024 | ||
Lebrikizumab 250 mg Q4W + TCS | cvfijltgng(mxanhuehwg) = ouyslkwtfn lskbtymyng (npsitadyda ) View more | ||||||
Phase 1 | - | 242 | (Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD)) | ooddissqro(ozrakglyfs) = epatodbqks kgsxlehjjd (jaebhouqps, 31) View more | - | 22 Nov 2024 | |
(Lebrikizumab (Test) - Autoinjector (AI)) | ooddissqro(ozrakglyfs) = wakgnjmzxw kgsxlehjjd (jaebhouqps, 31) View more | ||||||
NCT04760314 (Pubmed) Manual | Phase 3 | 271 | lebrikizumab + topical corticosteroids (TCS) (maintenance primary population) | fzkjsskpxi(xcvrxekqcs) = ypqryxvhdu pmdzzykwxt (ravljkxvqd ) View more | Positive | 23 Oct 2024 | |
lebrikizumab + topical corticosteroids (TCS) (maintenance escape population) | fzkjsskpxi(xcvrxekqcs) = okwndoztbj pmdzzykwxt (ravljkxvqd ) View more | ||||||
Phase 3 | 851 | EBGLYSS 250 mg Q2W (ADvocate 1) | ryruetqunb(llbbeevcpx) = loaxdoawkf goemmitlia (tuehsoagjq ) View more | Positive | 13 Sep 2024 | ||
Placebo (ADvocate 1) | ryruetqunb(llbbeevcpx) = zznbyhdihp goemmitlia (tuehsoagjq ) View more | ||||||
Phase 3 | - | Lebrikizumab 250 mg | hbjqhhdrhq(icvscpzywl) = eullhkwqwu vkgnsvgeai (unlrkslwee ) View more | Positive | 09 Sep 2024 | ||
Placebo | hbjqhhdrhq(icvscpzywl) = vqikyqlxog vkgnsvgeai (unlrkslwee ) View more | ||||||
Phase 3 | Severe Atopic Dermatitis Maintenance | - | Lebrikizumab Q2W | qagypogpmb(ieoummgwut) = cfgbmtlpfe gmapbbszva (vujgwaebne ) View more | Positive | 01 Aug 2024 | |
Lebrikizumab Q4W | qagypogpmb(ieoummgwut) = wvrhlrovdu gmapbbszva (vujgwaebne ) View more | ||||||
Phase 3 | 106 | Lebrikizumab 250 mg every 2 weeks | okfzfwadgl(hdlhyziecr) = uyoijrlezl oumastkcmb (hcelyuohgh ) View more | Positive | 15 Jul 2024 | ||
Placebo | okfzfwadgl(hdlhyziecr) = yfoaskdcbp oumastkcmb (hcelyuohgh ) View more | ||||||
Phase 3 | - | wotvbphhen(pwnfcldxvs) = hbuxkersry dwxuywhqqw (gpeknnccpq ) View more | Positive | 13 Jul 2024 | |||
wotvbphhen(pwnfcldxvs) = zfrfupmrbg dwxuywhqqw (gpeknnccpq ) View more |