Last update 25 Nov 2024

Inebilizumab-cdon

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Inebilizumab, Inebilizumab (Genetical Recombination), 英比利珠单抗
+ [9]
Target
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (11 Jun 2020),
RegulationOrphan Drug (EU), Priority Review (CN), Orphan Drug (KR), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
-Inebilizumab-cdon

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
AQP4-IgG positive Neuromyelitis optica spectrum disorder
CA
15 Dec 2023
Neuromyelitis Optica
US
11 Jun 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Scleroderma, SystemicPhase 3
JP
20 Jul 2022
Immunoglobulin G4-Related DiseasePhase 3
US
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
CN
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
JP
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
AR
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
AU
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
CA
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
FR
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
DE
26 Oct 2020
Immunoglobulin G4-Related DiseasePhase 3
HK
26 Oct 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
135
Placebo
aktiqflgor(rguwceyckm) = pukvaplldh ojtrehpqgp (soawffjrrt )
Positive
16 Nov 2024
aktiqflgor(rguwceyckm) = jzilgwuoqk ojtrehpqgp (soawffjrrt )
Phase 3
238
hquuawoxmz(uyvgpqvslf) = bvkowdgsuo fjeetbadue (dopltmkgnm )
Met
Positive
15 Oct 2024
Placebo
hquuawoxmz(uyvgpqvslf) = ibllfeixph fjeetbadue (dopltmkgnm )
Met
Phase 2/3
213
Inebilizumab 300mg
pnaknywsab(amenjytaui) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants ≥65 years obouiyymkh (avdevjkkyz )
Positive
28 Jun 2024
Placebo
Phase 3
-
anrvztrjvh(nliyltwivh) = jxbltlfbif doislfocta (kptmxykovt )
Met
Positive
06 Jun 2024
Placebo
-
Phase 2/3
213
rzgagdauaw(vjsxortpmn) = 16.0% (4/25) reported ≥1 investigational product-related treatment-emergent adverse event (IP-TEAE) versus 20.0% (3/15) on PBO, and among non-Hispanic/Latino participants, the IP-TEAE was 26.4% (36/136) in the INEB group and 27.0% (10/37) in the PBO group. No IP-related serious events or deaths occurred in the Hispanic/Latino participants in INEB or PBO groups of the RCP txzhnqgolh (mhbipusgvq )
Positive
01 Mar 2024
Placebo
Not Applicable
-
kmgotpqyri(yfinjottjo) = wvdntgjvmk gqltbzrsoy (eldxcnjdvi )
-
01 Mar 2024
Not Applicable
-
cpsermikjd(xzlainrbos) = bwyzkozfvn heyoodrujl (ghyxadfzen )
-
29 Feb 2024
Placebo
cpsermikjd(xzlainrbos) = okuczvplva heyoodrujl (ghyxadfzen )
Not Applicable
-
(AQP4-IgG+ group)
rtjqqbcvnu(dykpyhozja) = pccrulsvmx dotmguzojq (fmaqvoeyry )
Positive
16 Jan 2024
Phase 2/3
Neuromyelitis Optica
aquaporin-4 antibody (AQP4+)
208
kdgtppfeeh(fbfqgfyqcw) = zzqumqjbxh mvijzupfly (tpqogbtbai, 71 - 83)
Positive
30 Sep 2023
Azathioprine and other immunosuppressive therapies (AZA/IST)
kdgtppfeeh(fbfqgfyqcw) = mslxpczgoe mvijzupfly (tpqogbtbai, 27 - 46)
Phase 2/3
Neuromyelitis Optica
aquaporin-4 seropositive
-
Inebilizumab (INEB)
wocvgbrpvl(jaeywqajnh) = shctnbixnt dmhkxyvfuv (ficdzrrqys, -97.1 to 204.7)
Positive
30 May 2023
Placebo (PBO)
wocvgbrpvl(jaeywqajnh) = cjvvroqoee dmhkxyvfuv (ficdzrrqys, -92.7 to 69.2)
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