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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Scemblix
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Asciminib hydrochloride
Tradename
Company
Number
Date
Products
SCEMBLIXNovartisN-215358 RX2021-10-29
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
scemblixNew Drug Application2021-10-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia—D007951C92
Agency Specific
FDA
EMA
Expiration
Code
ASCIMINIB HYDROCHLORIDE, SCEMBLIX, NOVARTIS
2028-10-29ODE-381, ODE-382
2026-10-29NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Asciminib Hydrochloride, Scemblix, Novartis
114077352040-05-14DP
88291952033-05-13DPU-1374
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EA: Bcr-abl tyrosine kinase inhibitors
— L01EA06: Asciminib
HCPCS
No data
Clinical
Clinical Trials
24 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340365—215
Myeloid leukemia chronic-phaseD015466—31——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8021———2
Philadelphia chromosomeD010677—1———1
Hematologic diseasesD006402EFO_0005803D75.9—1———1
Biliary tract neoplasmsD001661C24.911———1
Myeloid leukemiaD007951C92—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-lymphomaD0542181————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameASCIMINIB
INNasciminib
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 classkinase 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-ID1492952-76-7
RxCUI—
ChEMBL IDCHEMBL4208229
ChEBI ID—
PubChem CID72165228
DrugBankDB12597
UNII IDL1F3R18W77 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
ABL1
ABL1
Organism
Homo sapiens
Gene name
ABL1
Gene synonyms
ABL, JTK7
NCBI Gene ID
25
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
Q45F09
Mouse ortholog
Abl1 (11350)
tyrosine-protein kinase ABL1 (P00520)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 341 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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70 adverse events reported
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