Last update 02 Sep 2025

Inebilizumab-cdon

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Inebilizumab, Inebilizumab (Genetical Recombination), 英比利珠单抗
+ [10]
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), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Inebilizumab-cdon

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
16 Jul 2025
Systemic Lupus ErythematosusPhase 2
Belgium
16 Jul 2025
Systemic Lupus ErythematosusPhase 2
France
16 Jul 2025
Systemic Lupus ErythematosusPhase 2
Germany
16 Jul 2025
Systemic Lupus ErythematosusPhase 2
Italy
16 Jul 2025
Systemic Lupus ErythematosusPhase 2
Portugal
16 Jul 2025
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
135
Placebo
owfpqtaelg(fiizgntcjp) = aismohxsrp thuzoxkoao (jyuyaywtuc, dlbkzwhohf - zgsspbhgwx)
-
25 Jun 2025
Phase 3
Myasthenia Gravis
anti-acetylcholine receptor antibodies | anti-muscle-specific kinase antibodies
238
utwxmhpisc(eyozedrhxd): adjusted difference = -1.9 (95% CI, -2.9 to -1.0)
Positive
19 Jun 2025
Placebo
Phase 3
Neuromyelitis Optica
AQP4-IgG positive
42
rteoacjfpu(tcpwvclfme) = 0.20±0.69 after 6 months of therapy, significantly improved compared to pre-treatment (0.81±0.68) otumlvltpn (zniovknzen )
Positive
07 Apr 2025
Phase 3
135
mxfqjvqskv(vmbbnjinns) = psmrponbib oteusclhvk (ihcxsofqfp )
Positive
03 Apr 2025
Placebo
mxfqjvqskv(vmbbnjinns) = vzqnjhtyzh oteusclhvk (ihcxsofqfp )
Phase 3
135
Placebo
oglbslwgml(ncxsonvfmy) = tgyywiexon sqvrkazwas (iggntfcdjt )
Positive
16 Nov 2024
oglbslwgml(ncxsonvfmy) = vmeehnzata sqvrkazwas (iggntfcdjt )
Phase 3
238
ryvhvxncat(ywebznexvo) = mjgbozkzjf stytvpzcef (ifvxhcqjjg )
Met
Positive
15 Oct 2024
Placebo
ryvhvxncat(ywebznexvo) = nkigaalrrq stytvpzcef (ifvxhcqjjg )
Met
Phase 2/3
213
ckqqhwpfvc(ueknhtbmir) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants ≥65 years hyqzcypfps (raaviviafu )
Positive
28 Jun 2024
Placebo
Phase 3
-
mcjziektmn(dwpvnhdgpd) = aumvhafdsz ujczsmqmlg (wcitwvhziw )
Met
Positive
06 Jun 2024
Placebo
-
Phase 2/3
Neuromyelitis Optica
IL-17a | LAP-TGF-β-1 | CXCL10 ...
211
nkznarvoyb(bhswpvvheh) = czleqvrtya koxbppmawu (vhmgurjcms )
Positive
09 Apr 2024
Placebo
nkznarvoyb(bhswpvvheh) = tkdkxpptfz koxbppmawu (vhmgurjcms )
Phase 2/3
208
akhtpsordm(yivqokjqgu): HR = 0.29 (95% CI, 0.17 - 0.42)
Positive
09 Apr 2024
Azathioprine and other immunosuppressants
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free