asciminib
Trade name: Scemblix
Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Oct 29, 2021
Clinical trial activity
28 trials · 21 clinical orgs · 1 marketing orgs
Phase 1
7
Phase 2
22
Phase 3
6
Phase 4
1
Earliest trial started Jul 31, 2018 (NCT03595917)
Timeline
2010s
Indications
Approved for
Studied for
- Biliary Tract Neoplasms · Phase 1/Phase 2
- Brain Neoplasms · Early Phase 1
- Hematologic Diseases · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 4
- Leukemia, Myeloid · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 3
- Leukemia, Myeloid, Chronic-Phase · Phase 3
- Leukemia, Myelomonocytic, Chronic · Phase 3
- Neoplasms · Phase 1/Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
Mechanism of action
- Bcr/Abl fusion proteinANTAGONIST
Bcr/Abl fusion protein antagonist
- Bcr/Abl fusion proteinINHIBITOR
Bcr/Abl fusion protein inhibitor
- Tyrosine-protein kinase ABLINHIBITOR
Tyrosine-protein kinase ABL inhibitor
ABL001 binds to a pocket on the BCR-ABL kinase domain that is normally occupied by the myristoylated N-terminus of ABL1 ("ABL001, a potent allosteric inhibitor of BCR-ABL, prevents emergence of resistant disease when administered in combination with nilotinib in an in vivo murine model of chronic myeloid leukemia". Blood. 2014;124(21) [abstract 398])
Approval history
- approvedPriority reviewAcceleratedFast trackBreakthroughOct 29, 2021
Chemistry & pharmacology
Loading structure…
SMILES
O=C(Nc1ccc(OC(F)(F)Cl)cc1)c1cnc(N2CC[C@@H](O)C2)c(-c2cc[nH]n2)c1- Mol. weight
- 449.85 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4297220 ↗
- ChEMBLCHEMBL4208229 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07040982 | Phase 1 | May 1, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07039760 | Early Phase 1 (Phase 1) | Dec 1, 2025 | Washington University in St. Louis |
| NCT07250087 | Phase 1 | Nov 30, 2025 | Novartis, University of South Florida |
| NCT07136428 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2025 | Duke University, Novartis |
| NCT06514534 | Phase 2 | Dec 2, 2024 | Novartis |
| NCT06629584 | Phase 2 | Dec 1, 2024 | Novartis, University of Texas at Houston |
| NCT06427811 | Phase 4 | Oct 15, 2024 | Novartis |
| NCT06409936 | Phase 2 | Sep 30, 2024 | Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica, Gruppo Italiano Malattie EMatologiche dell'Adulto |
| NCT06368414 | Phase 2 | Sep 1, 2024 | The Korean Society of Hematology |
| NCT06308588 | Phase 2 | Aug 5, 2024 | Novartis, University of Texas at Houston |
| NCT06236724 | Phase 2 | Jan 31, 2024 | Novartis, University of Texas at Houston |
| NCT05456191 | Phase 3 | Nov 21, 2022 | Novartis |
| NCT05413915 | Phase 3 | Aug 31, 2022 | McGill University, Novartis |
| NCT05384587 | Phase 2 | Aug 26, 2022 | Novartis |
| NCT04877522 | Phase 3 | May 16, 2022 | Novartis |
| NCT05143840 | Phase 2 | Feb 28, 2022 | Augusta University, Cure CML Consortium |
| NCT04795427 | Phase 2 | Jan 21, 2022 | Novartis |
| NCT04925479 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2021 | Novartis |
| NCT04838041 | Phase 2 | Nov 11, 2021 | Cure CML Consortium, Medical College of Wisconsin, Memorial Sloan-Kettering Cancer Center |
| NCT04948333 | Phase 3 | Oct 13, 2021 | Novartis |
Showing 20 of 28 trials
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Organizations
Research & Development (21)
21 organizations
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