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Iclusig(ponatinib)
Iclusig (ponatinib) is a small molecule pharmaceutical. Ponatinib was first approved as Iclusig on 2012-12-14. It is used to treat myeloid leukemia in the USA. It has been approved in Europe to treat lymphoid leukemia and myeloid leukemia. The pharmaceutical is active against tyrosine-protein kinase ABL1. In addition, it is known to target cyclin-dependent kinase 19, cyclin-dependent kinase 8, proto-oncogene tyrosine-protein kinase receptor Ret, receptor-interacting serine/threonine-protein kinase 3, receptor-interacting serine/threonine-protein kinase 2, and receptor-interacting serine/threonine-protein kinase 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Iclusig
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ponatinib hydrochloride
Tradename
Company
Number
Date
Products
ICLUSIGTakedaN-203469 RX2012-12-14
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
iclusigNew Drug Application2020-12-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia—D007951C92
Agency Specific
FDA
EMA
Expiration
Code
PONATINIB HYDROCHLORIDE, ICLUSIG, TAKEDA PHARMS USA
2023-12-18I-849
Patent Expiration
Patent
Expires
Flag
FDA Information
Ponatinib Hydrochloride, Iclusig, Takeda Pharms Usa
94934702033-12-12DS, DPU-1700, U-1948
111928952033-12-12U-1700, U-1701, U-1948
111928972033-12-12DPU-1700, U-1701, U-1948
113840862033-12-12DS, DPU-1700, U-1701, U-1948
81148742027-01-24DS, DP
90295332026-12-22U-836, U-1283, U-1699, U-1700, U-1701
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EA: Bcr-abl tyrosine kinase inhibitors
— L01EA05: Ponatinib
HCPCS
No data
Clinical
Clinical Trials
60 clinical trials
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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
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.04161—120
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003404101—518
Myeloid leukemia chronic-phaseD015466291——11
Non-small-cell lung carcinomaD002289151——5
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.057———9
LeukemiaD007938C9524——15
Philadelphia chromosomeD01067714——15
NeoplasmsD009369C8013———3
Myelodysplastic syndromesD009190D4611———2
Breast neoplasmsD001943EFO_0003869C5011———2
Myelomonocytic leukemia chronicD015477C93.111———2
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A—2———2
Gastrointestinal neoplasmsD005770C26.9—1———1
GlioblastomaD005909EFO_0000515—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD0193372————2
Prostatic neoplasmsD011471C611————1
Castration-resistant prostatic neoplasmsD0641291————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Multiple myelomaD009101C90.01————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
AnemiaD000740EFO_0004272D64.91————1
Hodgkin diseaseD006689C811————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Endometrial neoplasmsD016889EFO_0004230————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePONATINIB
INNponatinib
Description
Ponatinib is a benzamide obtained by the formal condensation of the carboxy group of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methylbenzoic acid with the anilino group of 4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)aniline. It is a multi-target tyrosine kinase inhibitor that targets ABL, SRC, FGFR, and others and was designed to overcome the resistance of BCR-ABL mutation to imatinib, in particular the gatekeeper mutation ABL(T315I). It has a role as an antineoplastic agent and a tyrosine kinase inhibitor. It is a N-methylpiperazine, a member of benzamides, an acetylenic compound, an imidazopyridazine and a member of (trifluoromethyl)benzenes. It is a conjugate base of a ponatinib(1+).
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(C(=O)Nc2ccc(CN3CCN(C)CC3)c(C(F)(F)F)c2)cc1C#Cc1cnc2cccnn12
Identifiers
PDB7WF5
CAS-ID943319-70-8
RxCUI1364347
ChEMBL IDCHEMBL1171837
ChEBI ID78543
PubChem CID24826799
DrugBankDB08901
UNII ID4340891KFS (ChemIDplus, GSRS)
Target
Agency Approved
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)
Alternate
CDK19
CDK19
CDK8
CDK8
RET
RET
RIPK3
RIPK3
RIPK2
RIPK2
RIPK1
RIPK1
Organism
Homo sapiens
Gene name
CDK19
Gene synonyms
CDC2L6, CDK11, KIAA1028
NCBI Gene ID
23097
Protein name
cyclin-dependent kinase 19
Protein synonyms
CDC2-related protein kinase 6, CDK8-like cyclin-dependent kinase, cell division cycle 2-like 6 (CDK8-like), Cell division cycle 2-like protein kinase 6, Cell division protein kinase 19, cyclin-dependent kinase (CDC2-like) 11, Cyclin-dependent kinase 11, Death-preventing kinase
Uniprot ID
Q9BWU1
Mouse ortholog
Cdk19 (78334)
cyclin-dependent kinase 19 (Q8BWD8)
Variants
Clinical Variant
No data
Financial
Iclusig - Takeda
$
€
£
₣
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Iclusig - Incyte
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,512 documents
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Safety
Black-box Warning
Black-box warning for: Iclusig
Adverse Events
Top Adverse Reactions
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58,091 adverse events reported
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