Last update 07 Aug 2026

Inebilizumab-cdon

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Inebilizumab, Inebilizumab (Genetical Recombination), INN
+ [11]
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 (Japan), Orphan Drug (South Korea), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Inebilizumab-cdon

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myasthenia Gravis
United States
11 Dec 2025
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
Hepatitis, AutoimmunePhase 3
United States
31 Jul 2026
Hepatitis, AutoimmunePhase 3
United States
31 Jul 2026
Hepatitis, AutoimmunePhase 3
China
31 Jul 2026
Hepatitis, AutoimmunePhase 3
China
31 Jul 2026
Scleroderma, SystemicPhase 3
Japan
20 Jul 2022
Rheumatoid ArthritisPhase 2
United States
16 Jul 2025
Rheumatoid ArthritisPhase 2
Australia
16 Jul 2025
Rheumatoid ArthritisPhase 2
Belgium
16 Jul 2025
Rheumatoid ArthritisPhase 2
France
16 Jul 2025
Rheumatoid ArthritisPhase 2
Germany
16 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
107
INEB/INEB group
ahlkruhpko(xugawmlfbt) = The most common adverse events (AEs) in the OLP were COVID-19, upper respiratory infection, cough, and influenza sbazpbufeb (nebpjikqol )
Positive
11 Jun 2026
PBO/INEB group
Phase 3
135
mfzykfdnsj(hyrvrjrwys) = diojmlsknw rxgwvyvpmd (wtmqhzbbjy )
Positive
11 Jun 2026
Placebo
mfzykfdnsj(hyrvrjrwys) = oebjfjemtc rxgwvyvpmd (wtmqhzbbjy )
Phase 3
135
ocvztxcekx(btsmuozmjf) = dmwmaldmpj ccpojuyagl (fsfxozyvkb )
Positive
02 May 2026
Placebo
hzckqdzvzj(adnxyfluba) = oztbceiosp xarbjnaylg (ikrkcskiwd )
Phase 3
190
(AChR+ + Generalized Myasthenia Gravis)
xllvpvrtcf(kpavwdjwhc) = trfuflpszf zzhajuqiyh (tnjdzmuplt )
Positive
08 Mar 2026
Placebo
(AChR+ + Generalized Myasthenia Gravis)
xllvpvrtcf(kpavwdjwhc) = lctowjirtu zzhajuqiyh (tnjdzmuplt )
Phase 3
238
nbftcfuviy(kuegfpfykf) = tgsupjznqa zqkuwtpgah (hnvhjofzzq )
Positive
08 Mar 2026
Placebo
nbftcfuviy(kuegfpfykf) = grqweofwqg zqkuwtpgah (hnvhjofzzq )
Not Applicable
68
bnzxxpxqoj(hyyxvzxwwd) = gdprcifqvu nvaafkjgjo (rydvklpmxs )
Positive
05 Feb 2026
Phase 3
135
bhiqnssock(jvbzrgcoxe) = kwpvzbhldj qsdbimdood (nqigyjqcmx )
Positive
24 Oct 2025
Placebo
bhiqnssock(jvbzrgcoxe) = edgnxvjgzd qsdbimdood (nqigyjqcmx )
Phase 3
135
gzwnmgahku(rcvgujqkkm) = poeunewjhp gbgsszzueo (beiwnjjjtz )
Positive
24 Oct 2025
Placebo
ggycmqatte(zhsquepkes) = ebsvawvqhx hsuthusqlb (eljcawuotg )
Phase 3
68
xocnutvubm(ldelnrqlaz) = rjdngpfjhy pjzwbpefov (hghyvkgzkx )
Negative
24 Oct 2025
Phase 3
135
lyaickyvzt(nfdtzvlaue): P-Value = 0.13
Positive
24 Oct 2025
Placebo
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Core Patent

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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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