Tasigna(nilotinib)
Tasigna (nilotinib) is a small molecule pharmaceutical. Nilotinib was first approved as Tasigna on 2007-10-29. It is used to treat myeloid leukemia accelerated phase and myeloid leukemia chronic-phase in the USA. It has been approved in Europe to treat BCR-ABL positive chronic myelogenous leukemia. The pharmaceutical is active against tyrosine-protein kinase ABL1. In addition, it is known to target epithelial discoidin domain-containing receptor 1 and discoidin domain-containing receptor 2.
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Novartis Pharmaceuticals
Drugs Approved for Childhood Cancers
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Commercial
Trade Name
FDA
EMA
Tasigna
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nilotinib hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TASIGNA | Novartis | N-022068 RX | 2007-10-29 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
tasigna | New Drug Application | 2020-12-08 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
NILOTINIB HYDROCHLORIDE, TASIGNA, NOVARTIS | |||
2029-03-23 | PED | ||
2028-09-23 | ODE-380 | ||
2025-09-22 | PED | ||
2025-03-22 | ODE-171, ODE-172 |
HCPCS
No data
Clinical
Clinical Trials
179 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 | 13 | 32 | 18 | 9 | 12 | 77 | |
Myeloid leukemia chronic-phase | D015466 | 3 | 9 | 3 | 3 | 1 | 17 | ||
Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 2 | 6 | 4 | 2 | 1 | 15 |
Philadelphia chromosome | D010677 | — | 1 | — | 2 | 1 | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Melanoma | D008545 | 1 | 4 | — | — | — | 5 | ||
Myeloid leukemia acute | D015470 | C92.0 | 2 | 4 | — | — | — | 4 | |
Neoplasms | D009369 | C80 | 1 | 2 | — | — | — | 3 | |
Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 2 | — | — | — | 3 |
Colorectal neoplasms | D015179 | 1 | 1 | — | — | — | 2 | ||
Residual neoplasm | D018365 | 1 | 1 | — | — | — | 2 | ||
Syndrome | D013577 | — | 2 | — | — | — | 2 | ||
Myeloid leukemia accelerated phase | D015465 | 2 | 2 | — | — | — | 2 | ||
Stem cell transplantation | D033581 | — | 2 | — | — | — | 2 | ||
Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 1 | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 6 | — | — | — | — | 6 | ||
Head and neck neoplasms | D006258 | 1 | — | — | — | — | 1 | ||
Huntington disease | D006816 | G10 | 1 | — | — | — | — | 1 | |
Colonic neoplasms | D003110 | C18 | 1 | — | — | — | — | 1 | |
Neurofibromatoses | D017253 | Q85.00 | 1 | — | — | — | — | 1 | |
Neurofibroma | D009455 | EFO_0000622 | 1 | — | — | — | — | 1 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
T-cell lymphoma peripheral | D016411 | C84.9 | 1 | — | — | — | — | 1 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
Lewy body disease | D020961 | EFO_0006792 | G31.83 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | NILOTINIB |
INN | nilotinib |
Description | Nilotinib is a member of (trifluoromethyl)benzenes, a member of pyrimidines, a member of pyridines, a member of imidazoles, a secondary amino compound and a secondary carboxamide. It has a role as an antineoplastic agent, a tyrosine kinase inhibitor and an anticoronaviral agent. |
Classification | Small molecule |
Drug class | tyrosine kinase inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1 |
Identifiers
PDB | 3CS9 |
CAS-ID | 641571-10-0 |
RxCUI | 662281 |
ChEMBL ID | CHEMBL255863 |
ChEBI ID | 52172 |
PubChem CID | 644241 |
DrugBank | DB04868 |
UNII ID | F41401512X (ChemIDplus, GSRS) |
Target
Agency Approved
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)
Alternate
DDR1
DDR1
DDR2
DDR2
Organism
Homo sapiens
Gene name
DDR1
Gene synonyms
CAK, EDDR1, NEP, NTRK4, PTK3A, RTK6, TRKE
NCBI Gene ID
Protein name
epithelial discoidin domain-containing receptor 1
Protein synonyms
CD167 antigen-like family member A, CD167a, Cell adhesion kinase, Discoidin receptor tyrosine kinase, HGK2, Mammary carcinoma kinase 10, MCK-10, neuroepithelial tyrosine kinase, neurotrophic tyrosine kinase, receptor, type 4, Protein-tyrosine kinase 3A, Protein-tyrosine kinase RTK-6, PTK3A protein tyrosine kinase 3A, TRK E, Tyrosine kinase DDR, Tyrosine-protein kinase CAK
Uniprot ID
Mouse ortholog
Ddr1 (12305)
epithelial discoidin domain-containing receptor 1 (Q03146)
Variants
Clinical Variant
No data
Financial
Tasigna - Novartis
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,556 documents
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Safety
Black-box Warning
Black-box warning for: Tasigna
Adverse Events
Top Adverse Reactions
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38 adverse events reported
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