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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
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
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
TASIGNANovartisN-022068 RX2007-10-29
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tasignaNew Drug Application2020-12-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia accelerated phase—D015465—
myeloid leukemia chronic-phase—D015466—
Agency Specific
FDA
EMA
Expiration
Code
NILOTINIB HYDROCHLORIDE, TASIGNA, NOVARTIS
2029-03-23PED
2028-09-23ODE-380
2025-09-22PED
2025-03-22ODE-171, ODE-172
Patent Expiration
Patent
Expires
Flag
FDA Information
Nilotinib Hydrochloride, Tasigna, Novartis
90610292032-04-07DPU-1374, U-3231
81639042028-08-23DS, DP
82937562027-09-25DP
83895372026-07-18U-1374
84153632026-07-18DS, DPU-1374, U-1407
85017602026-07-18DP
71697912023-07-04DS, DPU-836
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EA: Bcr-abl tyrosine kinase inhibitors
— L01EA03: Nilotinib
HCPCS
No data
Clinical
Clinical Trials
179 clinical trials
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Mock data
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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 leukemiaD015464EFO_000034013321891277
Myeloid leukemia chronic-phaseD0154663933117
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A2642115
Philadelphia chromosomeD010677—1—214
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.08101—114
LeukemiaD007938C95141——6
Myeloid leukemiaD007951C92—11——2
Alzheimer diseaseD000544EFO_0000249F03—11——2
SarcomaD012509——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854514———5
Myeloid leukemia acuteD015470C92.024———4
NeoplasmsD009369C8012———3
Parkinson diseaseD010300EFO_0002508G2012———3
Colorectal neoplasmsD01517911———2
Residual neoplasmD01836511———2
SyndromeD013577—2———2
Myeloid leukemia accelerated phaseD01546522———2
Stem cell transplantationD033581—2———2
Hypereosinophilic syndromeD017681EFO_1001467D72.1111——12
Show 24 more
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 neoplasmsD0062581————1
Huntington diseaseD006816G101————1
Colonic neoplasmsD003110C181————1
NeurofibromatosesD017253Q85.001————1
NeurofibromaD009455EFO_00006221————1
Non-hodgkin lymphomaD008228C85.91————1
T-cell lymphoma peripheralD016411C84.91————1
Breast neoplasmsD001943EFO_0003869C501————1
Lewy body diseaseD020961EFO_0006792G31.831————1
Show 1 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N19————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNILOTINIB
INNnilotinib
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 classtyrosine 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
PDB3CS9
CAS-ID641571-10-0
RxCUI662281
ChEMBL IDCHEMBL255863
ChEBI ID52172
PubChem CID644241
DrugBankDB04868
UNII IDF41401512X (ChemIDplus, GSRS)
Target
Agency Approved
ABL1
ABL1
Organism
Homo sapiens
Gene name
ABL1
Gene synonyms
ABL, JTK7
NCBI Gene ID
25
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
Q45F09
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
780
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
Q08345
Mouse ortholog
Ddr1 (12305)
epithelial discoidin domain-containing receptor 1 (Q03146)
Variants
Clinical Variant
No data
Financial
Tasigna - Novartis
$
€
£
₣
Mock data
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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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