Product Description
Sabatolimab is a first-in-class investigational immuno-myeloid therapy that binds to TIM-3, a novel target expressed on multiple immune cell types and leukemic cells and blasts, but not on the normal stem cells that induce blood formation; it is in development for HR-MDS and acute myeloid leukemia (AML). (Sourced from: https://www.novartis.com/news/novartis-receives-fda-fast-track-designation-sabatolimab-mbg453-myelodysplastic-syndromes)
Mechanisms of Action: TIM3 Antagonist
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Oman, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 13
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Preleukemia
Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia
Phase 1: Bone Marrow Diseases|Glioblastoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05201066 |
CMBG453B12206B | P2 |
Active, not recruiting |
Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia |
2028-02-14 |
2% |
2025-03-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2021210050 |
jRCT2021210050 | P2 |
Active, not recruiting |
Acute Myeloid Leukemia |
2026-04-30 |
|||
NCT03961971 |
J18150 | P1 |
Active, not recruiting |
Glioblastoma |
2022-11-16 |
12% |
2023-07-06 |
Primary Endpoints|Study Completion Date|Treatments |
NCT04266301 |
STIMULUS-MDS2 | P3 |
Completed |
Myelodysplastic Syndrome|Preleukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia, |
2024-10-02 |
81% |
2025-03-27 |
Primary Endpoints|Treatments|Trial Status |
2024-515281-14-00 |
CMBG453B12206B | P2 |
Active, not recruiting |
Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Acute Monocytic Leukemia|Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome|Acute Myelomonocytic Leukemia |
2028-02-14 |
2025-05-02 |
Treatments |
|
NCT03066648 |
CPDR001X2105 | P1 |
Completed |
Preleukemia|Chronic Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|Acute Myelomonocytic Leukemia|Bone Marrow Diseases|Myelodysplastic Syndrome|Acute Myeloid Leukemia|Acute Monocytic Leukemia |
2023-09-08 |
12% |
2023-10-03 |
Primary Endpoints|Treatments|Trial Status |
JapicCTI-205231 |
JapicCTI-205231 | P3 |
Active |
Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome |
2027-08-05 |
|||
2019-002089-11 |
2019-002089-11 | P3 |
Completed |
Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome |
2024-10-02 |
81% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
jRCT2021240013 |
jRCT2021240013 | P2 |
Recruiting |
Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome |
2028-09-30 |
|||
2021-004422-30 |
2021-004422-30 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome|Chronic Myeloid Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Acute Monocytic Leukemia|Chronic Myelomonocytic Leukemia |
2028-03-13 |
2025-05-06 |
Treatments |
|
2019-000439-14 |
STIMULUS-AML1 | P2 |
Completed |
Acute Myeloid Leukemia |
2026-08-21 |
74% |
2025-05-06 |
Treatments|Trial Status |
NCT04823624 |
NCT04823624 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2024-11-12 |
12% |
2025-09-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2018-004479-11 |
2018-004479-11 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2023-08-13 |
50% |
2025-05-06 |
Treatments |