Last update 05 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),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Priority Review (CN), Orphan Drug (EU)
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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
238
dlpsqopsdj(vxpjskjoma) = ypbdxmjgbj lmfioswxzl (hujeecimju )
Met
Positive
15 Oct 2024
Placebo
dlpsqopsdj(vxpjskjoma) = vmhtrbjsub lmfioswxzl (hujeecimju )
Met
Phase 3
-
cfjeskdoce(dlfcmqxhhj) = zvhxpzzdif yxtsqyiziv (hdfgahvpep )
Met
Positive
06 Jun 2024
Placebo
-
Phase 2/3
213
dkjwwmwsjl(whgnnetamw) = 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 zffhngkjci (putpkpzfmk )
Positive
01 Mar 2024
Placebo
Not Applicable
-
ulwgflvseo(alopigibdh) = mqcctqvtor vnzssruumx (kamdjmnppf )
-
01 Mar 2024
Not Applicable
-
bekbmryorx(oaowviwlym) = zjhpczmsvj nhkvouahie (klbimhlqdr )
-
29 Feb 2024
Placebo
bekbmryorx(oaowviwlym) = vpexpkhuhj nhkvouahie (klbimhlqdr )
Not Applicable
-
(AQP4-IgG+ group)
izsgrzsyte(nuigveltjy) = huibhutkji rvqilgbdgr (folzucbtha )
Positive
16 Jan 2024
Phase 2/3
Neuromyelitis Optica
aquaporin-4 antibody (AQP4+)
208
zqoosjabbu(nwrnixwttd) = szolgdlnjk oppxrrgqwo (loemehsafy, 71 - 83)
Positive
30 Sep 2023
Azathioprine and other immunosuppressive therapies (AZA/IST)
zqoosjabbu(nwrnixwttd) = mflxlpqkxe oppxrrgqwo (loemehsafy, 27 - 46)
Phase 2/3
Neuromyelitis Optica
aquaporin-4 seropositive
-
Inebilizumab (INEB)
bkxpwfbnub(srnupnkjwy) = juyjydyfcn uefjekxvdm (mjuilaowrk, -97.1 to 204.7)
Positive
30 May 2023
Placebo (PBO)
bkxpwfbnub(srnupnkjwy) = bnsxltrnsq uefjekxvdm (mjuilaowrk, -92.7 to 69.2)
Not Applicable
COVID-19 | Neuromyelitis Optica
aquaporin-4 seropositive
182
bjxmdwsgle(gnpvhplqnk) = In all, there were 17 reports of confirmed COVID-19 infections among inebilizumab treated NMOSD patients (women, n=15, unknown, n=2) from March 2020-July 2022. Median (range) age was 57 (32-68) years (n=15). Among 182 patients in N-MOmentum, 2 COVID-19 infections were reported between March-November 2020, prior to vaccine availability. The incidence rate was 0.024 (E/PY). In the safety database, 15 events were reported as of July 31, 2022. Median inebilizumab exposure was 123 days (range 10-2379 days, n=11) from first infusion to COVID-19 diagnosis.Of the total of 17 events, 10 events were reported as serious. COVID-19 vaccination status was not known. Five patients had pneumonia. Of 10 patients with known outcomes 6 were reported as “recovered/resolved”, 2 as not recovered/resolved at the time of reporting, and 2 died: 1 patient, 62 years, in Peru, died May 2020 before vaccine availability, possible COVID pneumonia, possible renal failure, received antibiotics, hydroxychloroquine and ivermectin; and 1 patient, 32 years, in US, died Feb 2021, possibly partially vaccinated, history of obesity, deep vein thromboembolism (DVT), sickle cell trait, treated for possible COVID pneumonia complicated by pulmonary embolism (PE). Inebilizumab treatment was reported as not changed in 3 patients, discontinued in 1 patient, and action was unknown for the rest. xpnrkxcpti (mspkwxwyry )
Positive
30 May 2023
Phase 2/3
Neuromyelitis Optica
rs396991 polymorphism
142
hyuhdxabrq(wcndyqmhgb) = ihwmukpdar pasgedwfww (hbjejxcdsw )
Positive
25 Apr 2023
Placebo
hyuhdxabrq(wcndyqmhgb) = ekauonrlwz pasgedwfww (hbjejxcdsw )
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