Scemblix(asciminib)
Scemblix (asciminib) is a small molecule pharmaceutical. Asciminib was first approved as Scemblix on 2021-10-29. It is used to treat myeloid leukemia in the USA. It has been approved in Europe to treat BCR-ABL positive chronic myelogenous leukemia. It is known to target tyrosine-protein kinase ABL1.
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FDA approval date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Scemblix
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| scemblix | New Drug Application | 2024-10-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia | — | D007951 | C92 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ASCIMINIB HYDROCHLORIDE, SCEMBLIX, NOVARTIS | |||
| 2028-10-29 | ODE-381, ODE-382 | ||
| 2026-10-29 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 3 | 15 | 6 | 2 | 8 | 33 |
| Leukemia | D007938 | — | C95 | 3 | 13 | 6 | 2 | 5 | 28 |
| Myeloid leukemia | D007951 | — | C92 | 3 | 11 | 6 | 2 | 7 | 28 |
| Myeloid leukemia chronic-phase | D015466 | — | — | — | 7 | 1 | 1 | 3 | 12 |
| Philadelphia chromosome | D010677 | — | — | 3 | 3 | 2 | 1 | — | 8 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 2 | 1 | — | — | — | 3 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 1 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 1 | — | — | — | — | 1 |
| Blast crisis | D001752 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Asciminib |
| INN | asciminib |
| Description | Asciminib, sold under the brand name Scemblix, is a medication used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Asciminib is a protein kinase inhibitor.
|
| Classification | Small molecule |
| Drug class | kinase inhibitor, binds to myristoyl binding site |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(Nc1ccc(OC(F)(F)Cl)cc1)c1cnc(N2CC[C@@H](O)C2)c(-c2cc[nH]n2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1492952-76-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4208229 |
| ChEBI ID | — |
| PubChem CID | 72165228 |
| DrugBank | DB12597 |
| UNII ID | L1F3R18W77 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ABL1
ABL1
Organism
Homo sapiens
Gene name
ABL1
Gene synonyms
ABL, JTK7
NCBI Gene ID
Protein name
tyrosine-protein kinase ABL1
Protein synonyms
Abelson murine leukemia viral oncogene homolog 1, Abelson tyrosine-protein kinase 1, ABL protooncogene 1 nonreceptor tyrosine kinase, BCR-ABL1 p190, BCR/ABL e8a2 fusion, BCR/ABL1 e1a2 fusion protein, bcr/c-abl oncogene protein, c-abl oncogene 1, receptor tyrosine kinase, p150, Proto-oncogene c-Abl, proto-oncogene tyrosine-protein kinase ABL1, v-abl Abelson murine leukemia viral oncogene homolog 1
Uniprot ID
Mouse ortholog
Abl1 (11350)
tyrosine-protein kinase ABL1 (P00520)
Variants
No data
Financial
Revenue by drug
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Scemblix – Novartis
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 704 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,123 adverse events reported
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