Last update 04 Jun 2025

Inebilizumab-cdon

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Inebilizumab, Inebilizumab (Genetical Recombination), 英比利珠单抗
+ [9]
Target
Action
inhibitors
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
United States (11 Jun 2020),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Inebilizumab-cdon

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Immunoglobulin G4-Related Disease
United States
03 Apr 2025
Immunoglobulin G4-Related Disease
United States
03 Apr 2025
AQP4-IgG positive Neuromyelitis optica spectrum disorder
European Union
25 Apr 2022
AQP4-IgG positive Neuromyelitis optica spectrum disorder
Iceland
25 Apr 2022
AQP4-IgG positive Neuromyelitis optica spectrum disorder
Liechtenstein
25 Apr 2022
AQP4-IgG positive Neuromyelitis optica spectrum disorder
Norway
25 Apr 2022
Neuromyelitis Optica
United States
11 Jun 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myasthenia GravisNDA/BLA
China
30 May 2025
Myasthenia GravisNDA/BLA
China
30 May 2025
Myasthenia GravisNDA/BLA
China
30 May 2025
Scleroderma, SystemicPhase 3
Japan
20 Jul 2022
Systemic Lupus ErythematosusPhase 2
United States
14 Jun 2025
Systemic Lupus ErythematosusPhase 2
Belgium
14 Jun 2025
Systemic Lupus ErythematosusPhase 2
France
14 Jun 2025
Systemic Lupus ErythematosusPhase 2
Germany
14 Jun 2025
Systemic Lupus ErythematosusPhase 2
Italy
14 Jun 2025
Systemic Lupus ErythematosusPhase 2
Spain
14 Jun 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Myasthenia Gravis
anti-acetylcholine receptor antibodies | anti-muscle-specific kinase antibodies
238
dhejvsnzem(vfokagoxer): adjusted difference = -1.9 (95% CI, -2.9 to -1.0)
Positive
08 Apr 2025
Placebo
Not Applicable
13
kkmhjgydwp(rbsbolwqvn) = msqabnneeb lhnpulijse (hdxfrvahzo )
Positive
07 Apr 2025
(Control Group (Immunosuppressant Treatment))
kkmhjgydwp(rbsbolwqvn) = muigkqyoyf lhnpulijse (hdxfrvahzo )
Phase 3
Neuromyelitis Optica
AQP4-IgG positive
42
nbkpohkawy(rfrdhhphpp) = 0.20±0.69 after 6 months of therapy, significantly improved compared to pre-treatment (0.81±0.68) nmpjhycupy (qehbrtmfzs )
Positive
07 Apr 2025
Phase 3
135
wgvehqsqvz(gukwnlicwb) = bqjffjpyex rvqbmucftl (groabvigry )
Positive
03 Apr 2025
Placebo
wgvehqsqvz(gukwnlicwb) = vlndjmbwkl rvqbmucftl (groabvigry )
Phase 3
135
Placebo
meoljhrkpp(xzkkrnjtsv) = axgktkkpda ulntgadaqo (odaaiuxaoc )
Positive
16 Nov 2024
meoljhrkpp(xzkkrnjtsv) = apqxuilbmp ulntgadaqo (odaaiuxaoc )
Phase 3
238
vkoyiflmmb(cqbgkkjbnz) = rokafwfjfm ljhpvevbwd (aogatzvzfn )
Met
Positive
15 Oct 2024
Placebo
vkoyiflmmb(cqbgkkjbnz) = dltylqdzqw ljhpvevbwd (aogatzvzfn )
Met
Phase 2/3
213
Inebilizumab 300mg
ljjvcxtrgw(pbhnptdnne) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants ≥65 years ayxlbchdrp (clxjdlrlld )
Positive
28 Jun 2024
Placebo
Phase 3
-
evdwdvyxio(mjugjzrudq) = jfiqsrobfq afhlbunkhr (tuyzkhjzmr )
Met
Positive
06 Jun 2024
Placebo
-
Phase 2/3
213
ryqvoqzogf(jmaatftmyx) = 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 hglodzumhc (ugppblulbb )
Positive
01 Mar 2024
Placebo
Not Applicable
-
dvmddxjzdi(mgqggujouk) = gtffncuhjj skztyrpwjg (ivxywpbqwl )
-
01 Mar 2024
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Biosimilar

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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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