Product Description
Asciminib is an allosteric inhibitor that binds a myristoyl site of the BCR-ABL1 protein, locking BCR-ABL1 into an inactive conformation through a mechanism distinct from those for all other ABL kinase inhibitors. Asciminib targets both native and mutated BCR-ABL1, including the gatekeeper T315I mutant. (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa1902328)
Mechanisms of Action: Bcr-Abl Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Bosnia | Chile | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Malaysia | Norway | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States
Approved Indications: Chronic Leukemia | Chronic Myeloid Leukemia | Leukemia | Myeloid Leukemia | Myeloid, Accelerated Leukemia
Known Adverse Events: Labor Pain | Pain Unspecified | Respiratory Tract Infections | Musculoskeletal Pain | Diarrhea
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Lebanon, Malaysia, Mexico, Netherlands, Norway, Oman, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam
Active Clinical Trial Count: 34
Highest Development Phases
Phase 3: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia
Phase 2: Biliary Tract Cancer|Precursor Cell Lymphoblastic Leukemia-Lymphoma
Phase 1: B-Cell Leukemia|Blast Crisis|Lymphoma, B-Cell|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCI-2024-00700 | P2 |
Recruiting |
Chronic Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia |
2033-07-01 |
|
| CABL001I12201 | P2 |
Unknown Status |
Chronic Myeloid Leukemia |
2031-06-26 |
|
| CABL001A2001B | P3 |
Unknown Status |
Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Chronic Lymphoid Leukemia|Acute Lymphoid Leukemia |
2030-08-30 |
|
| ASC4TARGET | P2 |
Not yet recruiting |
Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Myeloid Leukemia |
2028-12-01 |