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AboutPricing
Drug ReportsPonatinib
Iclusig(ponatinib)
Iclusig, Ponatinib (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 proto-oncogene tyrosine-protein kinase receptor Ret, receptor-interacting serine/threonine-protein kinase 3, cyclin-dependent kinase 8, receptor-interacting serine/threonine-protein kinase 2, cyclin-dependent kinase 19, and receptor-interacting serine/threonine-protein kinase 1.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Iclusig (discontinued: Ponatinib)
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 Application2024-12-19
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
80 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
LeukemiaD007938—C95141—16
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0131——4
Philadelphia chromosomeD010677——131——4
Lymphoid leukemiaD007945—C91131——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340——2——13
Myeloid leukemia chronic-phaseD015466———2———2
Myeloid leukemiaD007951—C92—2———2
Myeloid leukemia accelerated phaseD015465———1———1
Blast crisisD001752———1———1
Indications Phases 1
No data
Indications Without Phase
No data
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
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Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(C(=O)Nc2ccc(CN3CCN(C)CC3)c(C(F)(F)F)c2)cc1C#Cc1cnc2cccnn12
Identifiers
PDB—
CAS-ID943319-70-8
RxCUI—
ChEMBL IDCHEMBL1171837
ChEBI ID78543
PubChem CID24826799
DrugBankDB08901
UNII ID4340891KFS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CDK19
CDK19
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Iclusig – Takeda
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Iclusig – Incyte
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,826 documents
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Safety
Black-box Warning
Black-box warning for: Iclusig
Adverse Events
Top Adverse Reactions
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10,509 adverse events reported
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