Drugs / Isatuximab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Sarclisa | — | 2020-05-30 | europa.eu ↗ |
Trials 87 · started per year
today
EU approved 2020
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05862766 | Dec 2024 → Jan 2026 | anti-HLA hyperimmunization, transplant rejection | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 0 | NCT05284032 | Nov 2022 → Jun 2024 | blood platelet disease, hematopoietic and lymphoid cell neoplasm | Firas El Chaer, MD | Terminated | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT06203912 | Mar 2024 → May 2026 | plasma cell myeloma | Elvira Umyarova | Completed | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT04912427 | Apr → Dec 2022 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT04754945 | Apr 2021 → May 2027 expected | AL amyloidosis | Emory University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04083898 | Apr 2020 → Mar 2023 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT04045795 | Aug 2019 → Mar 2024 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03733717 | Oct 2018 → Sep 2020 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03530683 | May 2018 → Jul 2024 | acute myeloid leukemia, diffuse large B-cell lymphoma, plasma cell myeloma | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT02513186 | Sep 2015 → Jan 2022 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02514668 | Sep 2015 → Dec 2021 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02283775 | May 2015 → May 2021 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02332850 | Jan 2015 → Dec 2025 | plasma cell myeloma | Thomas Martin, MD | Completed | No outcome recorded |
| Phase 1 | NCT01749969 | Feb 2013 → Jun 2023 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/214 trials | ||||||
| Phase 1/2 | NCT07479979 | Jul 2026 → Jul 2027 expected | plasma cell myeloma | Natalie Callander | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07714512 | Jun 2026 → Jun 2028 expected | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07601100 | Jun 2026 → Jul 2029 expected | plasma cell myeloma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06119685 | Oct 2023 → Dec 2025 overdue | non-Hodgkin lymphoma, plasma cell myeloma | Indapta Therapeutics, INC. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07217184 | Jul 2021 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04643002 | Jan 2021 → Sep 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04294459 | Jun 2020 → May 2022 | immune system disorder | Sanofi | Terminated | No outcome recorded |
| Phase 1/2 | NCT04126200 | Oct 2019 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03769181 | Dec 2018 → Nov 2022 | lymphoma | Sanofi | Terminated | No outcome recorded |
| Phase 1/2 | NCT03555149 | Sep 2018 → Sep 2022 | colorectal cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT03194867 | Feb 2018 → Apr 2023 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/2 | NCT03367819 | Jan 2018 → Mar 2021 | non-small cell lung carcinoma, prostate cancer | Sanofi | Terminated | No outcome recorded |
| Phase 1/2 | NCT02812706 | Sep 2016 → Jul 2018 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/2 | NCT01084252 | May 2010 → Dec 2018 | hematopoietic and lymphoid cell neoplasm | Sanofi | Completed | No outcome recorded |
| Phase 245 trials | ||||||
| Phase 2 | NCT07585760 | Jul 2026 → May 2028 expected | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07652905 | Jun 2026 → Jun 2029 expected | plasma cell leukemia | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06517017 | Oct 2025 → Nov 2026 expected | plasma cell leukemia, plasma cell myeloma | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT06832865 | Aug 2025 → Dec 2026 expected | refractory plasma cell neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06762769 | Jun 2025 → Nov 2032 expected | smoldering plasma cell myeloma | University College, London | Recruiting | No outcome recorded |
| Phase 2 | NCT06356571 | Mar 2025 → Jan 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT05272826 | Dec 2024 → Mar 2028 expected | plasma cell myeloma | Canadian Myeloma Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06648889 | Oct 2024 → Feb 2028 expected | T-cell acute lymphoblastic leukemia | Goethe University | Recruiting | No outcome recorded |
| Phase 2 | NCT05922501 | May 2024 → Dec 2028 expected | plasma cell myeloma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05911321 | Dec 2023 → Jun 2025 overdue | plasma cell myeloma, refractory plasma cell neoplasm | UNC Lineberger Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05776979 | Aug 2023 → Dec 2027 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05873205 | Jul 2023 → Jun 2027 expected | hematopoietic and lymphoid system neoplasm | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05690984 | Jun 2023 → Sep 2026 expected | plasma cell myeloma | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05704049 | Apr 2023 → Dec 2025 overdue | refractory plasma cell neoplasm | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05669989 | Apr 2023 → Nov 2026 expected | plasma cell myeloma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05346809 | Mar 2023 → Sep 2026 expected | Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma | Divaya Bhutani | Recruiting | No outcome recorded |
| Phase 2 | NCT05344833 | Jan 2023 → Dec 2030 expected | plasma cell myeloma | University of Illinois at Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT04943302 | Sep 2022 → Sep 2024 | AL amyloidosis | Tufts Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05559827 | Sep 2022 → Oct 2026 expected | primary acquired red cell aplasia | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04850599 | Jun 2022 → Oct 2027 expected | plasma cell myeloma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05298683 | May 2022 → Nov 2025 | impaired renal function disease, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 2 | NCT05123131 | Apr 2022 → Jun 2025 overdue | plasma cell myeloma | Cancer Trials Ireland | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05147493 | Apr 2022 → Dec 2024 | impaired renal function disease, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 2 | NCT05145400 | Feb 2022 → May 2033 expected | plasma cell myeloma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05066607 | Feb 2022 → Mar 2026 | AL amyloidosis | Intergroupe Francophone du Myelome | Unknown | No outcome recorded |
| Phase 2 | NCT04835129 | Jan 2022 → Apr 2027 expected | plasma cell myeloma | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04240054 | Nov 2021 → Dec 2029 expected | plasma cell myeloma | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 2 | NCT05114109 | Nov 2021 → Dec 2022 | Cryoglobulinemic vasculitis, monoclonal gammopathy of uncertain significance, plasma cell myeloma | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2 | NCT04891809 | Oct 2021 → Dec 2027 expected | plasma cell myeloma | Study Group of Medical Tumour Therapy (AGMT) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04661033 | Sep 2021 → Jun 2023 | autoimmune hemolytic anemia, warm type | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT04883242 | Jul 2021 → Dec 2026 expected | plasma cell myeloma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04653246 | Jul 2021 → Dec 2025 overdue | plasma cell myeloma | Jacob Laubach, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04939844 | Jun 2021 → Aug 2024 | plasma cell myeloma | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04763616 | Jun 2021 → Apr 2023 | mature T-cell and NK-cell non-Hodgkin lymphoma | Won Seog Kim | Completed | No outcome recorded |
| Phase 2 | NCT04614558 | Jun 2021 → Apr 2026 overdue | monoclonal gammopathy | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT04558931 | Jun 2021 → Dec 2027 expected | plasma cell myeloma | Karolinska Institutet | Recruiting | No outcome recorded |
| Phase 2 | NCT04802031 | May 2021 → Nov 2022 | plasma cell myeloma | Thomas Martin, MD | Withdrawn | No outcome recorded |
| Phase 2 | NCT04965155 | Mar 2021 → Nov 2023 overdue | plasma cell myeloma | EMN Trial Office S.r.l. Impresa Sociale | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04287855 | Aug 2020 → Apr 2025 | plasma cell myeloma | Poitiers University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04430894 | Jul 2020 → Jul 2022 overdue | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03860844 | Aug 2019 → Sep 2022 | acute lymphoblastic leukemia, acute myeloid leukemia | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT03499808 | Jun 2018 → Aug 2023 | constipation disorder, diarrheal disease, lymph node disorder, macroglossia +2 | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT03104842 | Aug 2017 → May 2026 overdue | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02999633 | Mar → Nov 2017 | T lymphoblastic leukemia/lymphoma, precursor T-cell acute lymphoblastic leukemia | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT02960555 | Feb 2017 → Apr 2027 expected | smoldering plasma cell myeloma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06860269 | May 2025 → Mar 2035 expected | acute lymphoblastic leukemia | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05665140 | Feb 2023 → Aug 2027 expected | plasma cell myeloma | University Hopsital Schleswig Holstein Campus Lübeck | Recruiting | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT07624513 | Jun 2026 → Oct 2033 expected | plasma cell myeloma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06216158 | Apr 2024 → Dec 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT05804032 | Apr 2023 → Jan 2026 | plasma cell myeloma | University of Heidelberg Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT05558319 | Nov 2022 → Apr 2027 expected | plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT04934475 | Dec 2021 → Sep 2024 overdue | plasma cell myeloma | Intergroupe Francophone du Myelome | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04483739 | Sep 2020 → Jul 2025 overdue | plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03617731 | Oct 2018 → Jun 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03319667 | Dec 2017 → Apr 2027 expected | plasma cell myeloma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03275285 | Oct 2017 → Jan 2022 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02990338 | Dec 2016 → Nov 2018 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07334535 | Jan 2026 → Jul 2028 expected | plasma cell myeloma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07600151 Background | Dec 2026 → Sep 2036 expected | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03989414 Background | Sep 2019 → Nov 2026 expected | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07053436 Comparator | Apr 2026 → Oct 2035 expected | — | Multiple Myeloma Research Consortium | Recruiting | No outcome recorded |
| Phase 2 | NCT07045909 Background | Jun 2025 → Mar 2028 expected | plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06182774 Comparator | Apr 2024 → Jan 2032 expected | plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 3 | NCT05675319 Comparator | Mar 2023 → Mar 2025 | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded |
| Phase 3 | NCT05405166 Comparator | Jun 2022 → Nov 2024 overdue | plasma cell myeloma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04751877 Background | Jul 2021 → Jun 2024 overdue | plasma cell myeloma | Poitiers University Hospital | Active not recruiting | No outcome recorded |
Press releases naming this drug 33 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Sanofi | Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector sanofi.com ↗ |
| 2026-06-19 | Sanofi | Press Release: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma sanofi.com ↗ |
| 2026-06-08 | Sanofi | Press Release: Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector sanofi.com ↗ |
| 2026-04-22 | Sanofi | Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US sanofi.com ↗ |
| 2026-03-27 | Sanofi | Press Release: Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma sanofi.com ↗ |
| 2025-07-25 | Sanofi | Press Release: Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma sanofi.com ↗ |
| 2025-06-23 | Sanofi | Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma sanofi.com ↗ |
| 2025-06-03 | Sanofi | Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector sanofi.com ↗ |
| 2025-02-25 | Sanofi | Press Release: Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma sanofi.com ↗ |
| 2025-01-31 | Sanofi | Press Release: Sarclisa is the first anti-CD38 treatment in combination with standard-of-care VRd approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant sanofi.com ↗ |
| 2025-01-22 | Sanofi | Press Release: Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard-of-care VRd to treat transplant-ineligible newly diagnosed multiple myeloma sanofi.com ↗ |
| 2025-01-13 | Sanofi | Press Release: Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma sanofi.com ↗ |
| 2025-01-09 | Sanofi | Press Release: New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma sanofi.com ↗ |
| 2024-12-09 | Sanofi | Press Release: ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients sanofi.com ↗ |
| 2024-11-14 | Sanofi | Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma sanofi.com ↗ |
| 2024-09-20 | Sanofi | Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant sanofi.com ↗ |
| 2024-08-08 | Sanofi | Press Release: Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant sanofi.com ↗ |
| 2024-06-03 | Sanofi | Press Release: ASCO: Sarclisa is first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in phase 3 sanofi.com ↗ |
| 2024-05-27 | Sanofi | Press Release: Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma sanofi.com ↗ |
| 2023-12-11 | Sanofi | Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone sanofi.com ↗ |
| 2023-12-07 | Sanofi | Press Release: Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant sanofi.com ↗ |
| 2022-05-15 | Sanofi | Press Release: Sarclisa® (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy sanofi.com ↗ |
| 2021-12-11 | Sanofi | Sarclisa® (isatuximab) trial is first Phase 3 study to meet primary endpoint of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma sanofi.com ↗ |
| 2021-04-19 | Sanofi | European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma sanofi.com ↗ |
| 2021-03-31 | Sanofi | FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma sanofi.com ↗ |
| 2021-02-26 | Sanofi | Media Update: CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma sanofi.com ↗ |
| 2020-06-02 | Sanofi | Sarclisa® (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma sanofi.com ↗ |
| 2020-06-02 | Sanofi | European Commission approves Sarclisa® (isatuximab) for adults with relapsed and refractory multiple myeloma sanofi.com ↗ |
| 2020-05-12 | Sanofi | Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma sanofi.com ↗ |
| 2020-03-27 | Sanofi | Sanofi receives positive CHMP opinion for Sarclisa® (isatuximab) for the treatment of relapsed and refractory multiple myeloma sanofi.com ↗ |
| 2020-03-02 | Sanofi | Sanofi : FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma sanofi.com ↗ |
| 2013-12-09 | AbbVie | ImmunoGen, Inc. Announces Favorable Initial Safety and Response Findings for CD38-Targeting Anticancer Compound, SAR650984 abbvie.com ↗ |
| 2010-06-24 | AbbVie | ImmunoGen, Inc. Earns Milestone with Start of SAR650984 Clinical Trial abbvie.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 97 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isatuximab | “Isatuximab-KRd with Autologous Stem Cell Transplant” NCT07053436 ↗94 |
| Known as | ISA | “Isatuximab (ISA) is another IgG1 κ mAb that binds selectively to a unique epitope on the human CD38 receptor and has anti plasma cells activity via multiple mechanisms of action.” NCT05066607 ↗3“The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma.” NCT06762769 ↗ “The anti-CD38 antibody isatuximab (ISA, Sarclisa®, Immunogen, Sanofi-Aventis) is currently approved to treat myeloma patients in 2nd line.” NCT06860269 ↗ “anti-CD38 monoclonal antibody (Daratumumab [D] or Isatuximab [Isa])” NCT07045909 ↗ |
| Known as | Isatuximab-Irfc | “Isatuximab-Irfc 20 MG/ML [Sarclisa]” NCT04891809 ↗ |
| Known as | SAR650984 | “A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation” NCT04294459 ↗10“Isatuximab (SAR650984) in combination with Bortezomib (Velcade®), Lenalidomide and Dexamethasone” NCT03319667 ↗ “Drug: isatuximab SAR650984” NCT03769181 ↗ “Drug: Isatuximab SAR650984” NCT02999633 ↗ “isatuximab SAR650984 IV” NCT04045795 ↗ “SAR650984 (Isatuximab)” NCT02513186 ↗ “Isatuximab (SAR650984)” NCT03104842 ↗ “SAR650984 (Isatuximab)” NCT02283775 ↗ “Isatuximab SAR650984” NCT02812706 ↗ “Isatuximab SAR650984” NCT03194867 ↗ “Isatuximab SAR650984” NCT04661033 ↗ |
| Known as | Sarclisa | “The anti-CD38 antibody isatuximab (ISA, Sarclisa®, Immunogen, Sanofi-Aventis) is currently approved to treat myeloma patients in 2nd line.” NCT06860269 ↗ |
| Action | Inhibit | “Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.” NCT03499808 ↗ |
| Modality | Monoclonal antibody | “A Phase 2 dose-finding study evaluated isatuximab, an anti-CD38 monoclonal antibody, in relapsed/refractory multiple myeloma (RRMM; NCT01084252).” PMID 32409691 ↗ May 2020 |
| Route | Intravenous | “Route of administration: intravenous” NCT01749969 ↗ |
| Target | CD38 | “anti-CD38 monoclonal antibody isatuximab” PMID 28483761 ↗ May 2017 |