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) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Inebilizumab-cdon |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Myasthenia Gravis | NDA/BLA | China | 30 May 2025 | |
Myasthenia Gravis | NDA/BLA | China | 30 May 2025 | |
Myasthenia Gravis | NDA/BLA | China | 30 May 2025 | |
Scleroderma, Systemic | Phase 3 | Japan | 20 Jul 2022 | |
Systemic Lupus Erythematosus | Phase 2 | United States | 14 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Belgium | 14 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | France | 14 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Germany | 14 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Italy | 14 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Spain | 14 Jun 2025 |
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) View more | Positive | 08 Apr 2025 | ||
Placebo | |||||||
Not Applicable | 13 | kkmhjgydwp(rbsbolwqvn) = msqabnneeb lhnpulijse (hdxfrvahzo ) View more | Positive | 07 Apr 2025 | |||
(Control Group (Immunosuppressant Treatment)) | kkmhjgydwp(rbsbolwqvn) = muigkqyoyf lhnpulijse (hdxfrvahzo ) View more | ||||||
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 ) View more | Positive | 07 Apr 2025 | ||
NCT04540497 (FDA_CDER) Manual | Phase 3 | 135 | wgvehqsqvz(gukwnlicwb) = bqjffjpyex rvqbmucftl (groabvigry ) View more | Positive | 03 Apr 2025 | ||
Placebo | wgvehqsqvz(gukwnlicwb) = vlndjmbwkl rvqbmucftl (groabvigry ) View more | ||||||
Phase 3 | 135 | Placebo | meoljhrkpp(xzkkrnjtsv) = axgktkkpda ulntgadaqo (odaaiuxaoc ) View more | Positive | 16 Nov 2024 | ||
meoljhrkpp(xzkkrnjtsv) = apqxuilbmp ulntgadaqo (odaaiuxaoc ) View more | |||||||
Phase 3 | 238 | vkoyiflmmb(cqbgkkjbnz) = rokafwfjfm ljhpvevbwd (aogatzvzfn ) Met View more | Positive | 15 Oct 2024 | |||
Placebo | vkoyiflmmb(cqbgkkjbnz) = dltylqdzqw ljhpvevbwd (aogatzvzfn ) Met View more | ||||||
Phase 2/3 | 213 | Inebilizumab 300mg | ljjvcxtrgw(pbhnptdnne) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants ≥65âyears ayxlbchdrp (clxjdlrlld ) | Positive | 28 Jun 2024 | ||
Placebo | |||||||
Phase 3 | - | evdwdvyxio(mjugjzrudq) = jfiqsrobfq afhlbunkhr (tuyzkhjzmr ) Met | Positive | 06 Jun 2024 | |||
Placebo | - | ||||||
Phase 2/3 | Neuromyelitis Optica AQP4+ | 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 ) View more | - | 01 Mar 2024 |