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, Nilotinib, Nilotinib d-tartrate, 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
Nilotinib tartrate
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
227 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 | — | 10 | 17 | 18 | 12 | 12 | 64 |
| Leukemia | D007938 | — | C95 | 8 | 14 | 16 | 8 | 10 | 50 |
| Myeloid leukemia | D007951 | — | C92 | 8 | 14 | 14 | 9 | 9 | 48 |
| Philadelphia chromosome | D010677 | — | — | 4 | 4 | 5 | 3 | 1 | 15 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 2 | 6 | 4 | 2 | — | 14 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 6 | 4 | — | 1 | 1 | 8 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | 4 | — | 3 | 1 | 8 |
| Lymphoid leukemia | D007945 | — | C91 | 5 | 4 | — | 1 | 1 | 7 |
| Blast crisis | D001752 | — | — | 1 | 1 | 1 | 3 | 2 | 7 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | 2 | — | — | 1 | 3 |
| Melanoma | D008545 | — | — | 1 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | — | 2 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | 1 | — | — | — | 2 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 1 | 1 | — | — | 1 | 2 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | — | — | — | 1 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 1 | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | 1 | — | — | — | 1 |
| Systemic mastocytosis | D034721 | — | C96.21 | 1 | 1 | — | — | — | 1 |
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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 | — | — | — | 4 | — | — | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 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 |
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Indications Without Phase
No data
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
$
€
£
â‚£
Tasigna – Novartis
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 12,851 documents
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Safety
Black-box Warning
Black-box warning for: Danziten, Nilotinib, Tasigna
Adverse Events
Top Adverse Reactions
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32,990 adverse events reported
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