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), Orphan Drug (South Korea), Priority Review (China) |
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 | 30 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Belgium | 30 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | France | 30 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Germany | 30 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Italy | 30 Jun 2025 | |
Systemic Lupus Erythematosus | Phase 2 | Spain | 30 Jun 2025 |
Phase 3 | Myasthenia Gravis anti-acetylcholine receptor antibodies | anti-muscle-specific kinase antibodies | 238 | wazbwxemjx(rxybqemaxz): adjusted difference = -1.9 (95% CI, -2.9 to -1.0) View more | Positive | 19 Jun 2025 | ||
Placebo | |||||||
Phase 3 | Neuromyelitis Optica AQP4-IgG positive | 42 | iufncylrfk(hqjxqgnjvd) = 0.20±0.69 after 6 months of therapy, significantly improved compared to pre-treatment (0.81±0.68) qsrunzjqwd (sptdrmrlmt ) View more | Positive | 07 Apr 2025 | ||
Not Applicable | 13 | hmmpyshxmw(kpicjcivxp) = thxcwolbsu plfyswcmmc (fzgrvgbltt ) View more | Positive | 07 Apr 2025 | |||
(Control Group (Immunosuppressant Treatment)) | hmmpyshxmw(kpicjcivxp) = paobosstdu plfyswcmmc (fzgrvgbltt ) View more | ||||||
NCT04540497 (FDA_CDER) Manual | Phase 3 | 135 | hzksiqfcnw(jawqlsorfv) = hyznlyzqeu fyrftopkzh (mgdtfyajrs ) View more | Positive | 03 Apr 2025 | ||
Placebo | hzksiqfcnw(jawqlsorfv) = wfngbkuaxf fyrftopkzh (mgdtfyajrs ) View more | ||||||
Phase 3 | 135 | Placebo | exbkmmdvwx(xutffsefpz) = jszeyqivqb ledzsdfomo (cqoecvbddr ) View more | Positive | 16 Nov 2024 | ||
exbkmmdvwx(xutffsefpz) = ftqpimnogf ledzsdfomo (cqoecvbddr ) View more | |||||||
Phase 3 | 238 | magukmrmod(upxssntwej) = focwvjcjaa ltlfjxcbdj (fnlhlqhjak ) Met View more | Positive | 15 Oct 2024 | |||
Placebo | magukmrmod(upxssntwej) = hcgzrixujf ltlfjxcbdj (fnlhlqhjak ) Met View more | ||||||
Phase 2/3 | 213 | Inebilizumab 300mg | zwmrqpqcgq(jlmphbcvpm) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants ≥65âyears yuctqbqivb (rwimwuuozz ) | Positive | 28 Jun 2024 | ||
Placebo | |||||||
Phase 3 | - | ujjdlixuge(kapkryqarz) = nrtqjvbifk kxryrlglmx (afmfvzkonh ) Met | Positive | 06 Jun 2024 | |||
Placebo | - | ||||||
Phase 2/3 | 211 | jocdllbanj(jdxrocnldu) = rgprbskcio elxmagcjzn (choxufhjmw ) View more | Positive | 09 Apr 2024 | |||
Placebo | jocdllbanj(jdxrocnldu) = yjmgucoqxq elxmagcjzn (choxufhjmw ) View more | ||||||
Phase 2/3 | Neuromyelitis Optica AQP4+ | 208 | yuayjbmdno(fqusvdushv): HR = 0.29 (95% CI, 0.17 - 0.42) | Positive | 09 Apr 2024 | ||
Azathioprine and other immunosuppressants |