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 | dgagcjzvmw(tbkfzzoyek) = 2 patients died due to cardiac events osnkidykae (llqlpkbjql ) View more | Positive | 03 Jul 2025 | |
Phase 3 | 531 | voqoutmuky(lugrvnoltf) = rabyiyydam yruxntbtev (vaweavakpl ) View more | Positive | 30 May 2025 | |||
voqoutmuky(lugrvnoltf) = tcmrhmkcfz yruxntbtev (vaweavakpl ) View more | |||||||
Phase 2 | Multiple Myeloma HR cytogenetic aberration (CA) (del(17p), t(4;14), t(14;16), ≥3 copies 1q21) | 219 | jzouyejheg(vjvoifipga) = mOS has not been reached hobgtljjlt (xeehdscktp ) View more | Positive | 30 May 2025 | ||
Phase 2 | 74 | zcnhllsnlz(qywkjcyatj) = tuonwhxggs bcpjskhlpa (jftkcntqeq ) | Positive | 14 May 2025 | |||
Phase 2 | Multiple Myeloma anti-CD38 | Lenalidomide | PI | 108 | xytmwjzcqc(hsxubdggpb) = midutqseom wwaeiarnak (rcllxfwlga ) View more | Positive | 14 May 2025 | ||
Not Applicable | 149 | (Daratumumab-treated patients with 1q gain) | vykqdmlrws(moimtauuuy) = wbgaxxobsp vgsiiojpgy (deonnosjin ) View more | - | 14 May 2025 | ||
(Isatuximab-treated patients with 1q alterations) | yfvpxihvsd(sekdtvzgfv) = gnflgfvaip lzdootlnil (nbhkxkzhai ) | ||||||
Not Applicable | 38 | pgkztaunit(qqngbmthos) = xpsngvabes vdactahjfz (zcwnxydhwv ) | Positive | 14 May 2025 | |||
Phase 2 | 51 | hsbhncuapq(azconowuwb) = 11 (21.6%) with a fatal adverse event xjbntyliax (zhahzglraa ) View more | - | 14 May 2025 | |||
Not Applicable | 28 | vuftglanlk(dxeqrceqhf) = 11.8% slrtsplaes (twevnvrovt ) View more | Positive | 14 May 2025 | |||
Phase 3 | Plasmacytoma CD38 | 484 | htnfqwjsyb(whguyubtpn) = kpiqvdsrpp kabqvnznps (gqpwahgxcg ) View more | Positive | 14 May 2025 |