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Drug ReportsLapatinib
Tykerb, Tyverb(lapatinib)
Lapatinib, Tykerb, Tyverb (lapatinib) is a small molecule pharmaceutical. Lapatinib was first approved as Tykerb on 2007-03-13. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against receptor tyrosine-protein kinase erbB-2 and epidermal growth factor receptor.
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Novartis Pharmaceuticals
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Lapatinib, Tykerb
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lapatinib ditosylate
Tradename
Company
Number
Date
Products
TYKERBNovartisN-022059 RX2007-03-13
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lapatinibANDA2023-11-09
tykerbNew Drug Application2024-03-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Lapatinib Ditosylate, Tykerb, Novartis
88219272029-09-18DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EH: Human epidermal growth factor receptor 2 (her2) tyrosine kinase inhibitors
— L01EH01: Lapatinib
HCPCS
No data
Clinical
Clinical Trials
319 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C802017111351
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C506010734—14194
CarcinomaD002277—C80.04161—223
Neoplasm metastasisD009362EFO_0009708—7122—321
Brain neoplasmsD001932EFO_0003833C714111—117
Head and neck neoplasmsD006258——271——9
Urinary bladder neoplasmsD001749—C67341——7
AdenocarcinomaD000230——261——7
Stomach neoplasmsD013274EFO_0003897C16241——7
Male breast neoplasmsD018567——341——7
Inflammatory breast neoplasmsD058922———51——5
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——514——119
Colorectal neoplasmsD015179——35——29
Squamous cell carcinomaD002294———8———8
Prostatic neoplasmsD011471—C6124——27
Esophageal neoplasmsD004938—C1534———6
Ovarian neoplasmsD010051EFO_0003893C5643———6
Central nervous system neoplasmsD016543——43———5
Squamous cell carcinoma of head and neckD000077195———5———5
GlioblastomaD005909EFO_0000515—33———5
GliomaD005910EFO_0000520—33———5
Show 57 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal cell carcinomaD002292EFO_0000376—3————3
OncogenesD009857——1————1
Thyroid neoplasmsD013964EFO_0003841—1————1
Thyroid diseasesD013959HP_0000820E00-E071————1
LymphomaD008223—C85.91————1
Chronic renal insufficiencyD051436—N181————1
Chronic kidney failureD007676EFO_0003884N18.91————1
Kidney diseasesD007674EFO_0003086N081————1
CarcinosarcomaD002296——1————1
Mullerian mixed tumorD018200——1————1
Show 8 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carcinoma in situD002278—D09.9————22
Intraductal carcinoma noninfiltratingD002285—D05.1————22
LeukemiaD007938—C95————11
Myeloid leukemia acuteD015470—C92.0————11
Precursor cell lymphoblastic leukemia-lymphomaD054198——————11
Myeloid leukemiaD007951—C92————11
Acute diseaseD000208——————11
Lymphoid leukemiaD007945—C91————11
ExanthemaD005076HP_0000988—————11
Breast carcinoma in situD000071960—D05————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLapatinib
INNlapatinib
Description
Lapatinib is an organofluorine compound, an organochlorine compound, a member of quinazolines and a member of furans. It has a role as an antineoplastic agent and a tyrosine kinase inhibitor. It is functionally related to a monofluorobenzene.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1
Identifiers
PDB—
CAS-ID231277-92-2
RxCUI—
ChEMBL IDCHEMBL554
ChEBI ID49603
PubChem CID208908
DrugBankDB01259
UNII ID0VUA21238F (ChemIDplus, GSRS)
Target
Agency Approved
ERBB2
ERBB2
EGFR
EGFR
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 20,943 documents
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Safety
Black-box Warning
Black-box warning for: Lapatinib, Tykerb
Adverse Events
Top Adverse Reactions
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18,686 adverse events reported
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