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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Iclusig (discontinued: Ponatinib)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| iclusig | New Drug Application | 2025-10-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia | — | D007951 | C92 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PONATINIB HYDROCHLORIDE, ICLUSIG, TAKEDA PHARMS USA | |||
| 2023-12-18 | I-849 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ponatinib Hydrochloride, Iclusig, Takeda Pharms Usa | |||
| 9493470 | 2033-12-12 | DS, DP | U-1700, U-1948 |
| 11192895 | 2033-12-12 | U-1700, U-1701, U-1948 | |
| 11192897 | 2033-12-12 | DP | U-1700, U-1701, U-1948 |
| 11384086 | 2033-12-12 | DS, DP | U-1700, U-1701, U-1948 |
| 8114874 | 2027-01-24 | DS, DP | |
| 9029533 | 2026-12-22 | U-836, U-1283, U-1699, U-1700, U-1701 | |
HCPCS
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Clinical
Clinical Trials
85 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 8 | 27 | 5 | — | 14 | 46 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 6 | 22 | 2 | — | 15 | 41 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 6 | 24 | 3 | — | 7 | 34 |
| Myeloid leukemia | D007951 | — | C92 | 6 | 16 | 2 | — | 11 | 31 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 13 | 2 | — | 5 | 20 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 2 | 10 | 1 | — | 2 | 14 |
| Philadelphia chromosome | D010677 | — | — | 2 | 9 | 2 | — | 4 | 14 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 5 | 1 | — | — | 5 |
| Residual neoplasm | D018365 | — | — | — | 2 | 1 | — | — | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 5 | 7 | — | — | 1 | 10 |
| Blast crisis | D001752 | — | — | 3 | 7 | — | — | 1 | 9 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 2 | 6 | — | — | — | 7 |
| Neoplasms | D009369 | — | C80 | 2 | 4 | — | — | — | 5 |
| Recurrence | D012008 | — | — | — | 3 | — | — | 1 | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 2 | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 3 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | 1 | — | — | — | 2 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | — | — | — | 2 |
Show 18 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 2 | — | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | — | — | — | 1 | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ponatinib |
| INN | ponatinib |
| 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 class | tyrosine 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
| PDB | — |
| CAS-ID | 943319-70-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1171837 |
| ChEBI ID | 78543 |
| PubChem CID | 24826799 |
| DrugBank | DB08901 |
| UNII ID | 4340891KFS (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CDK19
CDK19
Organism
Homo sapiens
Gene name
CDK19
Gene synonyms
CDC2L6, CDK11, KIAA1028
NCBI Gene ID
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
Mouse ortholog
Cdk19 (78334)
cyclin-dependent kinase 19 (Q8BWD8)
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Iclusig
Adverse Events
Top Adverse Reactions
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11,539 adverse events reported
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