Ozmosi | Isatuximab Drug Profile

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 Indications: None

Known Adverse Events: None

Company: Sanofi
Company Location: Europe
Company Founding Year: 1973
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Isatuximab

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: 69

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

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT06648889	GMALL-Isatuximab	P2	Recruiting	Precursor Cell Lymphoblastic Leukemia-Lymphoma\|T-Cell Leukemia\|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma\|Lymphoid Leukemia	2028-02-01	12%	2024-12-06	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT06517017	UltraFrailMM	P2	Recruiting	Leukemia, Plasma Cell\|Multiple Myeloma	2026-11-01	12%	2025-10-15	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT05346809	AAAT7444	P2	Recruiting	Multiple Myeloma\|Lymphoma, Non-Hodgkin	2026-09-01	12%	2025-06-10
NCT05873205	NCT05873205	P2	Recruiting	Leukopenia\|Anemia, Refractory\|Purpura, Thrombocytopenic, Idiopathic\|Thrombocytopenia	2026-06-29	12%	2026-03-03	Primary Endpoints
NCT04614558	AAAT0761	P2	Recruiting	Paraproteinemias\|Monoclonal Gammopathy of Undetermined Significance	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
NCT05145400	LCCC 1944	P2	Recruiting	Multiple Myeloma	2026-03-01	2%	2022-07-29	Primary Endpoints
NCT04653246	NCT04653246	P2	Active, not recruiting	Stem Cell Transplant\|Multiple Myeloma	2025-12-15	12%	2025-12-24	Primary Completion Date\|Primary Endpoints\|Treatments\|Trial Status
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
2017-004634-28	2017-004634-28	P2	Active, not recruiting	Transitional Cell Carcinoma	2024-05-28		2022-03-13	Treatments
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\|Hepatocellular Carcinoma\|Ovarian Cancer\|Glioblastoma	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
NCT05922501	ISABELA	P2	Recruiting	Multiple Myeloma	2028-12-31	12%	2026-01-15	Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date\|Treatments\|Trial Status
2024-514989-40-00	ACT16482-03	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
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
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

Recent News Events

Date	Type	Title
01/06/2026	News Article	Enable Injections Announces $30 Million Investment from Sanofi to Accelerate Manufacturing Capabilities
11/13/2025	News Article	Regeneron Highlights Progress at American Society of Hematology (ASH), with Updated Data in Multiple Myeloma, Lymphoma and Paroxysmal Nocturnal Hemoglobinuria Programs
11/07/2025	News Article	Indapta Therapeutics Presents Data Demonstrating Clinical Activity of its Allogeneic Natural Killer Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma
11/04/2025	News Article	Next-Generation Multiple Myeloma Therapies Market to Reach USD 37.07 Billion by 2033, Driven by Accelerated Immunotherapy Approvals and Precision Medicine Advances - DataM Intelligence

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Isatuximab

Alternative Names: isatuximab, sar650984, sarclisa Clinical Status: Active Latest Update: 2026-03-05 Latest Update Note: Clinical Trial Update