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
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 |
|---|---|---|---|---|
| XELODA | CHEPLAPHARM Arzneimittel | N-020896 RX | 1998-04-30 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| capecitabine | ANDA | 2023-06-03 |
| xeloda | New Drug Application | 2023-04-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| colorectal neoplasms | — | D015179 | — |
Agency Specific
FDA
EMA
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Patent Expiration
No data
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 neoplasms | D001943 | EFO_0003869 | C50 | 64 | 194 | 100 | 7 | 25 | 352 |
| Colorectal neoplasms | D015179 | 55 | 181 | 67 | 10 | 11 | 281 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 33 | 110 | 48 | 1 | 7 | 179 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 54 | 93 | 16 | 1 | 5 | 140 |
| Neoplasms | D009369 | C80 | 96 | 45 | 11 | 1 | 7 | 139 | |
| Adenocarcinoma | D000230 | 12 | 32 | 11 | 1 | 3 | 50 | ||
| Pancreatic ductal carcinoma | D021441 | 1 | 4 | 3 | 1 | — | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rectal neoplasms | D012004 | 30 | 76 | 20 | — | 6 | 121 | ||
| Esophageal neoplasms | D004938 | C15 | 15 | 33 | 5 | — | 1 | 44 | |
| Triple negative breast neoplasms | D064726 | 10 | 31 | 7 | — | — | 41 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 8 | 23 | 4 | — | — | 31 |
| Biliary tract neoplasms | D001661 | C24.9 | 6 | 20 | 5 | — | 1 | 28 | |
| Colonic neoplasms | D003110 | C18 | 8 | 14 | 7 | — | — | 26 | |
| Renal cell carcinoma | D002292 | 12 | 14 | 2 | — | — | 25 | ||
| Nasopharyngeal neoplasms | D009303 | — | 13 | 11 | — | 1 | 25 | ||
| Neoplasm metastasis | D009362 | EFO_0009708 | 2 | 18 | 6 | — | — | 24 | |
| Cholangiocarcinoma | D018281 | C22.1 | 6 | 16 | 3 | — | 2 | 23 |
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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 neoplasms | D006258 | 5 | 12 | — | — | — | 14 | ||
| Squamous cell carcinoma | D002294 | 2 | 6 | — | — | — | 8 | ||
| Prostatic neoplasms | D011471 | C61 | 3 | 4 | — | — | — | 7 | |
| Bile duct neoplasms | D001650 | 3 | 6 | — | — | — | 7 | ||
| Uterine cervical neoplasms | D002583 | 2 | 4 | — | — | — | 6 | ||
| Lung neoplasms | D008175 | C34.90 | 2 | 3 | — | — | — | 5 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 4 | 2 | — | — | — | 4 | |
| Glioblastoma | D005909 | EFO_0000515 | 3 | 3 | — | — | — | 4 | |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 4 | — | — | — | 4 |
| Klatskin tumor | D018285 | EFO_1001005 | 1 | 2 | — | — | 1 | 4 |
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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-lymphoma | D054198 | C91.0 | 2 | — | — | — | — | 2 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 2 | — | — | — | — | 2 | |
| Hodgkin disease | D006689 | C81 | 2 | — | — | — | — | 2 | |
| Chemoradiotherapy | D059248 | 1 | — | — | — | 1 | 2 | ||
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Microbiota | D064307 | — | — | — | — | 1 | 1 | ||
| Prognosis | D011379 | — | — | — | — | 1 | 1 | ||
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | 1 | ||
| Proton therapy | D061766 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CAPECITABINE |
| INN | capecitabine |
| 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 class | nucleoside 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-ID | 154361-50-9 |
| RxCUI | 194000 |
| ChEMBL ID | CHEMBL1773 |
| ChEBI ID | 31348 |
| PubChem CID | 60953 |
| DrugBank | DB01101 |
| UNII ID | 6804DJ8Z9U (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000635263 | DPYD, 1129-5923C>G | drug response | 2021-05-24 | 1A |
| VCV000100116 | DPYD, 496A>G, Met166Val | drug response | 2021-03-29 | 1A |
| VCV000100100 | DPYD, 1236G>A, Glu412= | drug response | 2021-05-24 | 1A |
| VCV000100094 | DPYD, 1601G>A, Ser534Asn | drug response | 2021-03-24 | 1A |
| VCV000100092 | DPYD, 1627A>G, Ile543Val | drug response | 2021-03-24 | 1A |
| VCV000100088 | DPYD, 1896T>C, Phe632= | drug response | 2021-03-24 | 1A |
| VCV000100080 | DPYD, 2194G>A, Val732Ile | drug response | 2021-03-24 | 1A |
| VCV000088975 | DPYD, 1679T>G, Ile560Ser | drug response | 2021-05-26 | 1A |
| VCV000088974 | DPYD, 2846A>T, Asp949Val | drug response | 2021-05-24 | 1A |
| VCV000000435 | DPYD, 85T>C, Cys29Arg | drug response | 2021-03-24 | 1A |
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Financial
Xeloda - Roche
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Trends
PubMed Central
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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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