Overview
Asciminib is a tyrosine kinase inhibitor (TKI) used in the treatment of chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). More specifically, it is an inhibitor of the ABL1 kinase activity of the BCR-ABL1 fusion protein which serves as a driver of CML proliferation in most patients with the disease. It has also shown benefit in Ph+ CML with the T315I mutation, which produces a mutant BCR-ABL1 which is typically treatment-resistant as compared to wild-type BCR-ABL1. Existing inhibitors of ABL compete at the ATP binding sites of these proteins and can be classified into those that target the active conformation of the kinase domain (dasatinib, bosutinib) and those that target the inactive kinase domain (imatinib, nilotinib, ponatinib). Asciminib is unique in that it acts as an allosteric inhibitor, binding at the myristoyl pocket of the BCR-ABL1 protein and locking it into an inactive conformation. Asciminib received FDA approval on October 29, 2021 (Scemblix, Novartis AG).
Indication
Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with ≥2 tyrosine kinase inhibitors. It is also indicated in the treatment of Ph+ CML in adult patients with the T315I mutation.
Associated Conditions
- Chronic Phase Chronic Myeloid Leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Not yet recruiting | City of Hope Medical Center | ||
2025/06/26 | Phase 1 | Not yet recruiting | |||
2024/10/08 | Phase 2 | Recruiting | |||
2024/05/24 | Phase 4 | Recruiting | |||
2024/05/10 | Phase 2 | Recruiting | |||
2024/04/16 | Phase 2 | Not yet recruiting | Korean Society of Hematology | ||
2024/03/13 | Phase 2 | Recruiting | |||
2024/02/01 | Phase 2 | Recruiting | |||
2022/07/13 | Phase 3 | Active, not recruiting | |||
2022/06/10 | Phase 3 | Active, not recruiting | Sarit Assouline |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-1196 | ORAL | 100 mg in 1 1 | 6/18/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-1091 | ORAL | 20 mg in 1 1 | 6/18/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-1098 | ORAL | 40 mg in 1 1 | 6/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/25/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SCEMBLIX FILM-COATED TABLET 20 MG | SIN16539P | TABLET, FILM COATED | 20mg | 7/5/2022 | |
| SCEMBLIX FILM-COATED TABLET 40 MG | SIN16540P | TABLET, FILM COATED | 40 mg | 7/5/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SCEMBLIX TABLETS 40MG | N/A | N/A | N/A | 2/23/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet bottle | 407913 | Medicine | A | 9/18/2023 | |
| SCEMBLIX asciminib (as hydrochloride) 20 mg film-coated tablet blister pack | 371019 | Medicine | A | 7/15/2022 | |
| SCEMBLIX asciminib (as hydrochloride) 20 mg film-coated tablet bottle | 407914 | Medicine | A | 9/18/2023 | |
| SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet blister pack | 371018 | Medicine | A | 7/15/2022 |
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