Tasigna(nilotinib)
Danziten, 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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Danziten, Tasigna (discontinued: Nilotinib)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia chronic-phase | — | D015466 | — |
| myeloid leukemia accelerated phase | — | D015465 | — |
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
222 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 | — | 22 | 52 | 24 | 14 | 33 | 134 |
| Leukemia | D007938 | — | C95 | 22 | 51 | 23 | 11 | 32 | 126 |
| Myeloid leukemia | D007951 | — | C92 | 21 | 51 | 21 | 11 | 27 | 119 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 5 | 23 | 3 | 3 | 8 | 38 |
| Philadelphia chromosome | D010677 | — | — | 9 | 12 | 6 | 3 | 3 | 29 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 10 | 14 | 1 | 1 | 3 | 22 |
| Lymphoid leukemia | D007945 | — | C91 | 10 | 14 | — | 1 | 3 | 21 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 2 | 7 | 5 | 2 | 2 | 18 |
| Blast crisis | D001752 | — | — | 3 | 5 | 1 | 2 | 3 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 1 | — | — | 2 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 8 | — | — | 2 | 11 |
| Melanoma | D008545 | — | — | 1 | 5 | — | — | — | 6 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 4 | — | — | 1 | 5 |
| Recurrence | D012008 | — | — | 1 | 4 | — | — | 1 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 4 | — | — | — | 4 |
| Syndrome | D013577 | — | — | 1 | 3 | — | — | 1 | 4 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | — | 3 |
| Residual neoplasm | D018365 | — | — | 1 | 2 | — | — | — | 3 |
| Stem cell transplantation | D033581 | — | — | — | 3 | — | — | — | 3 |
| Graft vs host disease | D006086 | — | D89.81 | 2 | 1 | — | — | — | 3 |
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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 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 2 | — | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Huntington disease | D006816 | Orphanet_399 | G10 | 1 | — | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | 1 | — | — | — | — | 1 |
| Plexiform neurofibroma | D018318 | EFO_0000658 | — | 1 | — | — | — | — | 1 |
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 1 | — | — | — | — | 1 |
| Neurofibromatoses | D017253 | — | Q85.00 | 1 | — | — | — | — | 1 |
| Neurofibroma | D009455 | EFO_0000622 | — | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | — | — | — | — | 1 | 1 |
| Fatigue | D005221 | — | R53.83 | — | — | — | — | 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 | — |
| CAS-ID | 641571-10-0 |
| RxCUI | — |
| 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
No data
Variants
No data
Financial
Revenue by drug
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Tasigna – Novartis
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 11,687 documents
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Safety
Black-box Warning
Black-box warning for: Danziten, Tasigna
Adverse Events
Top Adverse Reactions
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32,616 adverse events reported
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