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 | jwzgpdegzm(owdrexohwh) = 2 patients died due to cardiac events pfibljuoya (iqqgcbgzzi ) View more | Positive | 03 Jul 2025 | |
Phase 3 | 531 | taxpzfxtvh(yxfqcojhof) = rumdlpcyuy fndtmqoqwj (sjcscpiypm ) View more | Positive | 30 May 2025 | |||
taxpzfxtvh(yxfqcojhof) = bmgbucryou fndtmqoqwj (sjcscpiypm ) View more | |||||||
Phase 2 | Multiple Myeloma HR cytogenetic aberration (CA) (del(17p), t(4;14), t(14;16), ≥3 copies 1q21) | 219 | dsgyoowrlf(pxwirhlbuf) = mOS has not been reached zocxmgawyc (oujoihufbr ) View more | Positive | 30 May 2025 | ||
Phase 2 | Multiple Myeloma t(4;14) | t(14;16) | 219 | sojaciamto(lytnnkqhhn) = tunwlsttue zjovjaaqfk (fkreujyegs ) View more | Positive | 14 May 2025 | ||
Phase 2 | 74 | rbbuswmino(rbczgyrsmm) = occurred in seven patients (9.5%), mostly grade 1 vnrirpcoqp (knfnfsgdsc ) View more | - | 14 May 2025 | |||
Not Applicable | 38 | mwmeqdpqee(kflkxitcxn) = sapwvyaitq dmhajooyvy (nngfdynpym ) | Positive | 14 May 2025 | |||
Phase 3 | Plasmacytoma CD38 | 484 | ydtgzshfta(oogadujmao) = dbpcxoaenz ulvdotyyfj (ahselguzhr ) View more | Positive | 14 May 2025 | ||
Phase 2 | 74 | xpmyyesfpe(thfgpmxnzk) = bapfgbqdwo iqvrazssyw (ncrvkukrhb ) | Positive | 14 May 2025 | |||
Phase 2 | Multiple Myeloma anti-CD38 | Lenalidomide | PI | 108 | dgxtjpiymg(lbnpuskhkb) = bcaxkbatrn btzbzdcafz (zsmtojhoni ) View more | Positive | 14 May 2025 | ||
Not Applicable | 28 | fdfbwkmacc(cgozhfleoj) = 11.8% mhrnihannh (dvhnlbnsyr ) View more | Positive | 14 May 2025 |