Product Description
Isatuximab-irfc injection is used along with pomalidomide (Pomalyst) and dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) in adults who have received at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used along with carfilzomib (Kyprolis) and dexamethasone to treat multiple myeloma in adults whose cancer has returned or is unresponsive to at least one other treatment. Isatuximab-irfc injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a620023.html)
Mechanisms of Action: CD38 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Priority Review - Multiple Myeloma *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russia, Serbia, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Sanofi presented P3 Multiple Myeloma results on 2025-01-09 for Isatuximab
- Clinical Outcomes Reported - Sanofi presented P3 Multiple Myeloma results on 2024-08-08 for Isatuximab
- Clinical Outcomes Reported - Sanofi presented P3 Multiple Myeloma results on 2024-06-03 for Isatuximab
Highest Development Phases
Phase 3: Multiple Myeloma|Stem Cell Transplant
Phase 2: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Amyloidosis|Anemia, Hemolytic, Autoimmune|Anemia, Refractory|Blood Protein Disorders|Glioblastoma|Head and Neck Cancer|Hepatocellular Carcinoma|Kidney Diseases|Leukemia, Plasma Cell|Leukopenia|Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Monoclonal Gammopathy of Undetermined Significance|Ovarian Cancer|Paraproteinemias|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Purpura, Thrombocytopenic, Idiopathic|Squamous Cell Carcinoma|T-Cell Leukemia|T-Cell Lymphoma|Thrombocytopenia|Transitional Cell Carcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06648889 |
GMALL-Isatuximab | P2 |
Recruiting |
T-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
2028-02-01 |
12% |
2024-12-06 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06517017 |
UltraFrailMM | P2 |
Recruiting |
Multiple Myeloma|Leukemia, Plasma Cell |
2026-11-01 |
12% |
2025-10-15 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05346809 |
AAAT7444 | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2026-09-01 |
12% |
2025-06-10 |
|
NCT05873205 |
NCT05873205 | P2 |
Recruiting |
Purpura, Thrombocytopenic, Idiopathic|Anemia, Refractory|Thrombocytopenia|Leukopenia |
2026-06-29 |
12% |
2023-11-08 |
Primary Endpoints|Start Date|Treatments |
NCT04614558 |
AAAT0761 | P2 |
Recruiting |
Monoclonal Gammopathy of Undetermined Significance|Paraproteinemias |
2026-04-01 |
50% |
2025-06-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05066607 |
IsAMYP | P2 |
Recruiting |
Amyloidosis |
2026-03-01 |
57% |
2024-03-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05922501 |
ISABELA | P2 |
Not yet recruiting |
Multiple Myeloma |
2025-12-01 |
49% |
2024-02-03 |
Primary Endpoints|Start Date|Treatments |
NCT05298683 |
EAE115 | P2 |
Not yet recruiting |
Blood Protein Disorders|Multiple Myeloma|Paraproteinemias|Kidney Diseases |
2025-11-01 |
12% |
2022-03-29 |
Primary Endpoints|Treatments |
NCT04653246 |
NCT04653246 | P2 |
Recruiting |
Stem Cell Transplant|Multiple Myeloma |
2025-09-15 |
68% |
2024-06-04 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
2017-004634-28 |
2017-004634-28 | P2 |
Active, not recruiting |
Transitional Cell Carcinoma |
2024-05-28 |
2022-03-13 |
Treatments |
|
2020-003880-24 |
2020-003880-24 | P2 |
Completed |
Anemia, Hemolytic, Autoimmune |
2023-06-26 |
48% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
2018-002697-45 |
ISAKIDS | P2 |
Completed |
Acute Myeloid Leukemia|Acute Lymphoid Leukemia |
2023-05-26 |
46% |
2025-06-09 |
Treatments |
NCT04763616 |
ICING | P2 |
Recruiting |
T-Cell Lymphoma |
2023-04-30 |
23% |
2021-09-26 |
Primary Endpoints |
2018-000390-67 |
2018-000390-67 | P2 |
Completed |
Squamous Cell Carcinoma|Head and Neck Cancer|Glioblastoma|Ovarian Cancer|Hepatocellular Carcinoma |
2023-01-13 |
12% |
2025-05-06 |
Treatments |
NCT07053436 |
MMRC Horizon Two | P2 |
Not yet recruiting |
Multiple Myeloma |
2035-10-01 |
2025-07-09 |
Primary Endpoints|Treatments |
|
NCT06762769 |
MODIFY | P2 |
Recruiting |
Multiple Myeloma |
2032-11-01 |
12% |
2025-08-05 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
2024-514990-23-00 |
ACT16482-04 | P2 |
Recruiting |
Multiple Myeloma |
2028-09-22 |
2025-05-02 |
Treatments |
|
2024-514993-38-00 |
ACT16482-06 | P2 |
Recruiting |
Multiple Myeloma |
2028-09-22 |
2025-05-02 |
Treatments |
|
2024-514992-16-00 |
ACT16482-05 | P2 |
Recruiting |
Multiple Myeloma |
2028-09-22 |
2025-05-02 |
Treatments |
|
2024-514988-25-00 |
ACT16482-01 | P2 |
Recruiting |
Multiple Myeloma |
2028-09-22 |
2025-05-02 |
Treatments |
|
2023-507419-37-00 |
EFC15992 | P3 |
Active, not recruiting |
Multiple Myeloma |
2034-05-30 |
2025-05-02 |
Treatments |
|
jRCT2031210017 |
jRCT2031210017 | P3 |
Active, not recruiting |
Multiple Myeloma |
2033-08-31 |
|||
NCT04270409 |
EFC15992 | P3 |
Active, not recruiting |
Multiple Myeloma |
2030-10-14 |
53% |
2024-11-01 |
|
2024-517008-12-00 |
GEM21menos65 | P3 |
Recruiting |
Multiple Myeloma |
2029-05-09 |
2025-05-02 |
Treatments |
|
2021-004130-11 |
2021-004130-11 | P3 |
Active, not recruiting |
Multiple Myeloma|Stem Cell Transplant |
2029-02-12 |