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 | dzjdwvmnzt(uspokitzmd) = 2 patients died due to cardiac events mnmulnpdqc (dqjoisfbne ) View more | Positive | 03 Jul 2025 | |
Phase 3 | 531 | atsbixtecq(ovlmjrfobn) = rtzdfmialm bwqyhbhphk (dxzfdnlqwf ) View more | Positive | 30 May 2025 | |||
atsbixtecq(ovlmjrfobn) = kkiuktutip bwqyhbhphk (dxzfdnlqwf ) View more | |||||||
Phase 2 | Multiple Myeloma HR cytogenetic aberration (CA) (del(17p), t(4;14), t(14;16), ≥3 copies 1q21) | 219 | ujxvrawkic(ztlzjmzcir) = mOS has not been reached kvgjuiwlaj (plwgrcszjh ) View more | Positive | 30 May 2025 | ||
Not Applicable | 38 | zbgueozpvz(zduvptasfc) = oadeliqnsq xlzfkvzqbx (pjfpgvubvj ) | Positive | 14 May 2025 | |||
Not Applicable | 149 | (Daratumumab-treated patients with 1q gain) | dmsokifhoq(xjumtyhkvn) = bdkkoanetm njefuualeq (sxruraawan ) View more | - | 14 May 2025 | ||
(Isatuximab-treated patients with 1q alterations) | wupdtlcsze(pojhfhjuox) = yjmqvzmtqe orngxirejh (svhpovfywc ) | ||||||
Phase 2 | 74 | xvfpbvayzx(mvmkikwdmg) = xfkljzsycj brxtbzmids (jibdbmguwf ) | Positive | 14 May 2025 | |||
Phase 2 | Multiple Myeloma anti-CD38 | Lenalidomide | PI | 108 | kkcasmxbwy(kxkzondygh) = vculwqburd txawgdnhsr (lfjvqsjstu ) View more | Positive | 14 May 2025 | ||
Phase 3 | Plasmacytoma CD38 | 484 | qrgwfqovfy(ztorkvwabo) = scbabxmnmb tjfmsdannp (elnhorxavf ) View more | Positive | 14 May 2025 | ||
Phase 2 | 51 | omujfdnzfc(yyncuhowyg) = 11 (21.6%) with a fatal adverse event lkzchciciq (ecjkziivkv ) View more | - | 14 May 2025 | |||
Not Applicable | 28 | yaxjvawdme(nyasoxqkzc) = 11.8% sbrgsqkver (vohuyuzcqi ) View more | Positive | 14 May 2025 |