> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/isatuximab-a4041fba-ee04-4ad4-a6fc-39e24da4aedb > Record changed: 2026-10-13 # Isatuximab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) First approval year 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) ## Development status **First approval year** 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) **Drug name** Isatuximab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) ### Brand names (2) - sarclisa - Sarclisa ### Other names (27) - isatuximab - Isatuximab - Isatuximab (for expansion) - Isatuximab (for run-in portion) - isatuximab \[INN\] - ISATUXIMAB \[JAN\] - ISATUXIMAB \[MI\] - ISATUXIMAB \[USAN\] - Isatuximab \[WHO-DD\] - Isatuximab Injection - isatuximab inn - isatuximab irfc - Isatuximab irfc - Isatuximab irfc \[WHO-DD\] - isatuximab irfc who dd - Isatuximab IV - isatuximab jan - isatuximab mi - isatuximab usan - isatuximab who dd - Isatuximab-irfc - sar 650984 - SAR-650984 - sar650984 - SAR650984 And 2 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 1461640-62-9 **ChEMBL ID** CHEMBL3545131 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) **FDA ingredient codes (UNII)** - R30772KCU0 ### ATC classification codes (2) - L01FC02 - L01XC38 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545131) ### RxNorm IDs (RxCUI) (2) - 2282018 - 2282019 ## Regulatory information ### United States **Applicant** SANOFI AVENTIS US **Approval date** 2 Mar 2020 **Application number** BLA761113 ### European Union **Status** Authorised **Status date** 30 May 2020 **Authorisation date** 30 May 2020 **Approved indications** Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. **Product number** EMEA/H/C/004977 **Authorisation holder** Sanofi Winthrop Industrie **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Multiple Myeloma European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa) ### Other regulatory facts **Patents** 0 **Designations** 1 **Earliest recorded loss of exclusivity** 20 Sept 2031 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** isatuximab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** CD38 **Gene symbol** CD38 **Protein identifier** P28907 **Affinity units** pKd **Primary target** Yes - **Mechanism** Lymphocyte differentiation antigen CD38 inhibitor **Action type** Inhibitor **Target** ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 **Protein identifier** P28907 ### Open Targets mechanisms - **Mechanism** Lymphocyte differentiation antigen CD38 inhibitor **Action type** Inhibitor **Target** ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 ### Investigated indications (16) - **Condition** Paraproteinemias **Highest recorded phase** 2 **Condition identifier** EFO:0000203 **Subject identifier** D010265 - **Condition** Precursor Cell Lymphoblastic Leukemia-Lymphoma **Highest recorded phase** 2 **Condition identifier** EFO:0000220 **Subject identifier** D054198 - **Condition** Leukemia, Myeloid, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000222 **Subject identifier** D015470 - **Condition** Lymphoma, Large B-Cell, Diffuse **Highest recorded phase** 1 **Condition identifier** EFO:0000403 **Subject identifier** D016403 - **Condition** Immune System Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0000540 **Subject identifier** D007154 - **Condition** Lymphoma **Highest recorded phase** 2 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Multiple Myeloma **Highest recorded phase** 4 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Hematologic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0001642 **Subject identifier** D019337 - **Condition** Smoldering Multiple Myeloma **Highest recorded phase** 2 **Condition identifier** EFO:0003073 **Subject identifier** D000075122 - **Condition** Leukemia, T-Cell **Highest recorded phase** 2 **Condition identifier** EFO:0005592 **Subject identifier** D015458 - **Condition** Anemia, Hemolytic, Autoimmune **Highest recorded phase** 1 **Condition identifier** EFO:1001264 **Subject identifier** D000744 - **Condition** Red-Cell Aplasia, Pure **Highest recorded phase** 2 **Condition identifier** MONDO:0001705 **Subject identifier** D012010 - **Condition** Colorectal Neoplasms **Highest recorded phase** 1 **Condition identifier** MONDO:0005575 **Subject identifier** D015179 - **Condition** Amyloidosis, Familial **Highest recorded phase** 2 **Condition identifier** MONDO:0019438 **Subject identifier** D028226 - **Condition** Precursor T-Cell Lymphoblastic Leukemia-Lymphoma **Highest recorded phase** 2 **Condition identifier** MONDO:0044917 **Subject identifier** D054218 ### Open Targets indications (38) - **Condition identifier** EFO\_0000203 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000209 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000540 - **Condition identifier** EFO\_0000574 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0001378 - **Condition identifier** EFO\_0003073 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004599 **Highest recorded phase** 2 - **Condition identifier** EFO\_0010134 **Highest recorded phase** 1 - **Condition identifier** EFO\_1001264 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001830 **Highest recorded phase** 2 - **Condition identifier** HP\_0012410 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0000430 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0001705 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0003539 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004963 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004967 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005062 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005140 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005235 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005240 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005575 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0007256 **Highest recorded phase** 1 And 13 more, listed on the interactive page. ### Reported adverse events (34) - **Event** acute kidney injury **Reports** 25 **Reporting signal score** 10.8082 - **Event** arthralgia **Reports** 1 **Reporting signal score** 12.5371 - **Event** asthenia **Reports** 1 **Reporting signal score** 12.1214 - **Event** atypical haemolytic uraemic syndrome **Reports** 3 **Reporting signal score** 9.76386 - **Event** cholangiocarcinoma **Reports** 3 **Reporting signal score** 8.81575 - **Event** covid-19 **Reports** 19 **Reporting signal score** 21.3533 - **Event** covid-19 pneumonia **Reports** 10 **Reporting signal score** 26.0815 - **Event** cytomegalovirus colitis **Reports** 4 **Reporting signal score** 9.32198 - **Event** dizziness **Reports** 1 **Reporting signal score** 17.2993 - **Event** fatigue **Reports** 9 **Reporting signal score** 10.7 - **Event** febrile bone marrow aplasia **Reports** 12 **Reporting signal score** 31.1148 - **Event** febrile infection **Reports** 7 **Reporting signal score** 24.711 - **Event** febrile neutropenia **Reports** 36 **Reporting signal score** 46.3557 - **Event** gastrointestinal inflammation **Reports** 5 **Reporting signal score** 9.79567 - **Event** giant cell myocarditis **Reports** 2 **Reporting signal score** 12.9671 - **Event** headache **Reports** 4 **Reporting signal score** 14.0315 - **Event** hypogammaglobulinaemia **Reports** 5 **Reporting signal score** 8.59962 - **Event** infusion related reaction **Reports** 74 **Reporting signal score** 154.796 - **Event** ivth nerve paralysis **Reports** 3 **Reporting signal score** 12.7252 - **Event** lymphopenia **Reports** 11 **Reporting signal score** 15.2739 - **Event** malaise **Reports** 2 **Reporting signal score** 11.0276 - **Event** neutropenia **Reports** 57 **Reporting signal score** 58.5187 - **Event** parainfluenzae virus infection **Reports** 5 **Reporting signal score** 15.5114 - **Event** pericarditis infective **Reports** 2 **Reporting signal score** 8.92568 - **Event** plasma cell myeloma **Reports** 20 **Reporting signal score** 29.9944 And 9 more, listed on the interactive page. ### Trial references (66) - NCT01084252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01084252) - NCT01749969 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01749969) - NCT02283775 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02283775) - NCT02332850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02332850) - NCT02513186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02513186) - NCT02514668 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02514668) - NCT02812706 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02812706) - NCT02990338 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02990338) - NCT03104842 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03104842) - NCT03194867 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03194867) - NCT03275285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03275285) - NCT03319667 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03319667) - NCT03530683 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03530683) - NCT03617731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03617731) - NCT03733717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03733717) - NCT03989414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03989414) - NCT04045795 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04045795) - NCT04083898 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04083898) - NCT04126200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04126200) - NCT04240054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04240054) - NCT04270409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04270409) - NCT04287855 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04287855) - NCT04430894 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04430894) - NCT04483739 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04483739) - NCT04558931 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04558931) And 41 more, listed on the interactive page. ## Dosing **Dose** 10 mg/kg **Route** Intravenous **How often** See dosing schedules in clinical studies and tables ### Conditions of use (4) - Administer by healthcare professional - Administer infusion over the time specified in infusion rate table - Premedicate with dexamethasone, acetaminophen, H2 antagonist, and diphenhydramine - Prepare infusion using aseptic technique, administer within 48 hours of preparation ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Light chain **Type** Protein **Sequence** DIVMTQSHLSMSTSLGDPVSITCKASQDVSTVVAWYQQKPGQSPRRLIYSASYRYIGVPDRFTGSGAGTDFTFTISSVQAEDLAVYYCQQHYSPPYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC - **Component** Heavy chain **Type** Protein **Sequence** QVQLVQSGAEVAKPGTSVKLSCKASGYTFTDYWMQWVKQRPGQGLEWIGTIYPGDGDTGYAQKFQGKATLTADKSSKTVYMHLSSLASEDSAVYYCARGDYYGSNSLDYWGQGTSVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK ## National Drug Codes - 0024-0654 - 0024-0656 - 0024-0674 ## Related records ### Trials (151) - A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia - A Clinical Trial of KVA12123 \[TBS-2025\] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101) - A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma - A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors - A Phase 1b Study of WU-NK-101 in Combination With Cetuximab - A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment - A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor - [A Phase I Study of CFT8919 in Patients With Advanced NSCLC](https://trialight.com/data/trial/a-phase-i-study-of-cft8919-in-patients-with-advanced-nsclc-f10a39b9-d38e-4ea2-9400-e94cdd4058c3.md) - A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation - [A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors](https://trialight.com/data/trial/a-phase-i-study-of-sim0609-in-adult-participants-with-686dce27-c618-4aa1-84d0-980853be7370.md) - [A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )](https://trialight.com/data/trial/a-phase-i-ii-study-of-absk141-in-patients-with-advanced-b74d8020-e88b-4829-8d17-b87584bf7284.md) - A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 - A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001) - A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) - A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) - A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors - A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors - A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors - A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary - A Study of Isatuximab-based Therapy in Participants With Lymphoma ### Approved for (2) - Neoplasm - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) ### In development for (17) - Acute lymphoblastic leukemia Phase 2 - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 2 - AL amyloidosis Phase 2 - Autoimmune hemolytic anemia Phase 1 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 1 - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 1 - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) Phase 1 - Lymphoid neoplasm Phase 1 - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 2 - Monoclonal gammopathy Phase 2 - Precursor T-cell acute lymphoblastic leukemia Phase 2 - Pure red-cell aplasia Phase 2 - Smoldering plasma cell myeloma Phase 2 - T-cell acute lymphoblastic leukemia Phase 2 - T-cell leukemia Phase 2 - T-lymphoblastic lymphoma Phase 2 - Timothy syndrome Phase 2 ### Targets (1) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) Lymphocyte differentiation antigen CD38 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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