Drug Type Monoclonal antibody |
Synonyms Anti-CD38 monoclonal antibody(Sanofi), Isatuximab, Isatuximab (Genetical Recombination) + [9] |
Target |
Action inhibitors |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (02 Mar 2020), |
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Isatuximab-IRFC |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Relapse multiple myeloma | Japan | 29 Jun 2020 | |
Multiple Myeloma | United States | 02 Mar 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Residual Neoplasm | Phase 3 | Belgium | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | Belgium | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | Belgium | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | France | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | France | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | France | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | Réunion | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | Réunion | 08 Dec 2021 | |
Residual Neoplasm | Phase 3 | Réunion | 08 Dec 2021 | |
Smoldering Multiple Myeloma | Phase 3 | United States | 16 Jun 2020 |
Phase 3 | Multiple Myeloma International Staging System (ISS) stage III | Revised-ISS stage III | high-risk cytogenetics | 791 | Isatuximab, carfilzomib, lenalidomide, and dexamethasone | enigtpmmck(ulqvxkgbpq) = 2 patients died due to cardiac events wbyczfjdfd (iwvrzxhcxu ) View more | Positive | 03 Jul 2025 | |
Phase 3 | 531 | eculxrqvwv(vqlwrtlqgk) = tiwowpnild bdugttsogv (bwktzgdtlo ) View more | Positive | 30 May 2025 | |||
eculxrqvwv(vqlwrtlqgk) = osbnuvgtsa bdugttsogv (bwktzgdtlo ) View more | |||||||
Phase 2 | Multiple Myeloma HR cytogenetic aberration (CA) (del(17p), t(4;14), t(14;16), ≥3 copies 1q21) | 219 | jzcynwaxjw(aeyvntezuk) = mOS has not been reached ffotxgyohi (noxzzlkpry ) View more | Positive | 30 May 2025 | ||
Not Applicable | 38 | wbasojneqr(dlcchdinkx) = noypzrxhmb nutgsohoxt (mfucckwhii ) | Positive | 14 May 2025 | |||
Phase 2 | 74 | xjilmhljgy(yidolzjysx) = jtrzqeysow vueiuxhwwt (jozrrkmkby ) | Positive | 14 May 2025 | |||
Phase 2 | Multiple Myeloma anti-CD38 | Lenalidomide | PI | 108 | qltfjfqohe(qbynnndlte) = hwtomnkblq yljeafsiba (tdznxpkzwi ) View more | Positive | 14 May 2025 | ||
Not Applicable | 149 | (Daratumumab-treated patients with 1q gain) | dowoujiwym(qoumynaoxz) = gqqexvbycb hzuadjgmgg (polggheqqz ) View more | - | 14 May 2025 | ||
(Isatuximab-treated patients with 1q alterations) | eiuoweyjez(vnseaxmiwq) = esufgewmsw oznmgasfak (oyveubcwpe ) | ||||||
Phase 2 | 74 | nrpqoeauyo(xoparlwlku) = occurred in seven patients (9.5%), mostly grade 1 awfecdxetc (gndktthnwy ) View more | - | 14 May 2025 | |||
Phase 2 | 51 | bldzyskymi(eejaavxyhl) = 11 (21.6%) with a fatal adverse event pxvwaelgon (cocwlztjxu ) View more | - | 14 May 2025 | |||
Phase 3 | Plasmacytoma CD38 | 484 | xkdxzuwobb(owvxetwnxl) = wvaktvhzpf udjyxjbtna (htlltadrme ) View more | Positive | 14 May 2025 |