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: Europe
Company Founding Year: 1996
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Portugal, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 11
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome
Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia
Phase 1: Bone Marrow Diseases|Glioblastoma|Juvenile Myelomonocytic Leukemia,|Preleukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03066648 |
CPDR001X2105 | P1 |
Completed |
Acute Myelomonocytic Leukemia|Acute Monocytic Leukemia|Chronic Myeloid Leukemia|Acute Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Preleukemia|Myelodysplastic Syndrome|Juvenile Myelomonocytic Leukemia,|Bone Marrow Diseases |
2023-09-08 |
12% |
2023-10-03 |
Primary Endpoints|Treatments|Trial Status |
NCT03961971 |
J18150 | P1 |
Active, not recruiting |
Glioblastoma |
2022-11-16 |
12% |
2023-07-06 |
Primary Endpoints|Study Completion Date|Treatments |
2024-515281-14-00 |
CMBG453B12206B | P2 |
Active, not recruiting |
Acute Myeloid Leukemia|Acute Monocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Acute Myelomonocytic Leukemia|Myelodysplastic Syndrome |
2028-02-14 |
2025-05-02 |
Treatments |
|
NCT05201066 |
CMBG453B12206B | P2 |
Active, not recruiting |
Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia |
2028-02-14 |
12% |
2025-03-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2021210050 |
jRCT2021210050 | P2 |
Active, not recruiting |
Acute Myeloid Leukemia |
2026-04-30 |
|||
2019-002089-11 |
2019-002089-11 | P3 |
Completed |
Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia |
2024-10-02 |
48% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
2021-004422-30 |
2021-004422-30 | P2 |
Active, not recruiting |
Acute Monocytic Leukemia|Chronic Myeloid Leukemia|Acute Myelomonocytic Leukemia|Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia|Acute Myeloid 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 |
2018-004479-11 |
2018-004479-11 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2023-08-13 |
50% |
2025-05-06 |
Treatments |
JapicCTI-205231 |
JapicCTI-205231 | P3 |
Active |
Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia |
2027-08-05 |
|||
jRCT2021240013 |
jRCT2021240013 | P2 |
Recruiting |
Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome |
2028-09-30 |