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Xeloda(capecitabine)
Xeloda (capecitabine) is a small molecule pharmaceutical. Capecitabine was first approved as Xeloda on 1998-04-30. It is used to treat breast neoplasms and colorectal neoplasms in the USA. It has been approved in Europe to treat breast neoplasms, colonic neoplasms, colorectal neoplasms, and stomach neoplasms. The pharmaceutical is active against thymidylate synthase.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Xeloda (generic drugs available since 2013-09-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Capecitabine
Tradename
Company
Number
Date
Products
XELODACHEPLAPHARM ArzneimittelN-020896 RX1998-04-30
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
capecitabineANDA2023-06-03
xelodaNew Drug Application2023-04-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
colorectal neoplasmsD015179
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01B: Antimetabolites
L01BC: Pyrimidine analogues, antineoplastic antimetabolites
L01BC06: Capecitabine
HCPCS
Code
Description
J8520
Capecitabine, oral, 150 mg
J8521
Capecitabine, oral, 500 mg
Clinical
Clinical Trials
1556 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5064194100725352
Colorectal neoplasmsD01517955181671011281
Stomach neoplasmsD013274EFO_0003897C16331104817179
Pancreatic neoplasmsD010190EFO_0003860C2554931615140
NeoplasmsD009369C8096451117139
AdenocarcinomaD0002301232111350
Pancreatic ductal carcinomaD02144114318
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD0120043076206121
Esophageal neoplasmsD004938C1515335144
Triple negative breast neoplasmsD0647261031741
Liver neoplasmsD008113EFO_1001513C22.0823431
Biliary tract neoplasmsD001661C24.96205128
Colonic neoplasmsD003110C18814726
Renal cell carcinomaD0022921214225
Nasopharyngeal neoplasmsD0093031311125
Neoplasm metastasisD009362EFO_0009708218624
CholangiocarcinomaD018281C22.16163223
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Head and neck neoplasmsD00625851214
Squamous cell carcinomaD002294268
Prostatic neoplasmsD011471C61347
Bile duct neoplasmsD001650367
Uterine cervical neoplasmsD002583246
Lung neoplasmsD008175C34.90235
Non-hodgkin lymphomaD008228C85.9424
GlioblastomaD005909EFO_0000515334
Kidney neoplasmsD007680EFO_0003865C6444
Klatskin tumorD018285EFO_10010051214
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.022
B-cell chronic lymphocytic leukemiaD015451C91.122
Hodgkin diseaseD006689C8122
ChemoradiotherapyD059248112
Myelodysplastic syndromesD009190D4611
Myeloid leukemia acuteD015470C92.011
Hematologic neoplasmsD01933711
Primary myelofibrosisD055728D47.411
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011
Myelomonocytic leukemia chronicD015477C93.111
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MicrobiotaD06430711
PrognosisD01137911
ObesityD009765EFO_0001073E66.911
Sclerosing cholangitisD015209EFO_0004268K83.0111
RecurrenceD01200811
Proton therapyD06176611
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCAPECITABINE
INNcapecitabine
Description
Capecitabine is a carbamate ester that is cytidine in which the hydrogen at position 5 is replaced by fluorine and in which the amino group attached to position 4 is converted into its N-(penyloxy)carbonyl derivative. Capecitabine is a antineoplastic agent used in the treatment of cancers. It has a role as an antineoplastic agent, a prodrug and an antimetabolite. It is a carbamate ester, an organofluorine compound and a member of cytidines.
Classification
Small molecule
Drug classnucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F
Identifiers
PDB
CAS-ID154361-50-9
RxCUI194000
ChEMBL IDCHEMBL1773
ChEBI ID31348
PubChem CID60953
DrugBankDB01101
UNII ID6804DJ8Z9U (ChemIDplus, GSRS)
Target
Agency Approved
TYMS
TYMS
Organism
Homo sapiens
Gene name
TYMS
Gene synonyms
TS
NCBI Gene ID
Protein name
thymidylate synthase
Protein synonyms
TSase
Uniprot ID
Mouse ortholog
Tyms (22171)
thymidylate synthase (P07607)
Alternate
No data
Variants
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000635263DPYD, 1129-5923C>Gdrug response2021-05-241A
VCV000100116DPYD, 496A>G, Met166Valdrug response2021-03-291A
VCV000100100DPYD, 1236G>A, Glu412=drug response2021-05-241A
VCV000100094DPYD, 1601G>A, Ser534Asndrug response2021-03-241A
VCV000100092DPYD, 1627A>G, Ile543Valdrug response2021-03-241A
VCV000100088DPYD, 1896T>C, Phe632=drug response2021-03-241A
VCV000100080DPYD, 2194G>A, Val732Iledrug response2021-03-241A
VCV000088975DPYD, 1679T>G, Ile560Serdrug response2021-05-261A
VCV000088974DPYD, 2846A>T, Asp949Valdrug response2021-05-241A
VCV000000435DPYD, 85T>C, Cys29Argdrug response2021-03-241A
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Financial
Xeloda - Roche
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,792 documents
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Safety
Black-box Warning
Black-box warning for: Capecitabine, Xeloda
Adverse Events
Top Adverse Reactions
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9,574 adverse events reported
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