Capecitabine - PharmaKB

Xeloda(capecitabine)

Capecitabine, Ecansya, 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

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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
neoplasms	D009369
digestive system diseases	D004066
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Xeloda (generic drugs available since 2013-09-16)

Drug Products

FDA

EMA

New Drug Application (NDA)

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	2024-01-04
capecitabine 150mg	ANDA	2020-12-22
capecitabine 150mg capecitabine 500mg	ANDA	2019-11-07
capecitabine 500mg	ANDA	2020-12-26
capecitabine tablets, 150 mg capecitabine tablets, 500 mg	Export only	2019-04-21
xeloda	New Drug Application	2023-12-08

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
breast neoplasms	EFO_0003869	D001943	C50
colorectal neoplasms	—	D015179	—

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

2261 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	77	227	115	8	39	423
Colorectal neoplasms	D015179	—	—	70	238	83	12	30	376
Stomach neoplasms	D013274	EFO_0003897	C16	43	144	65	1	16	241
Rectal neoplasms	D012004	—	—	35	112	39	2	31	202
Neoplasms	D009369	—	C80	103	50	17	1	19	167
Pancreatic neoplasms	D010190	EFO_0003860	C25	59	109	19	2	7	164
Adenocarcinoma	D000230	—	—	15	47	15	1	4	70
Esophageal neoplasms	D004938	—	C15	19	38	6	1	4	57
Colonic neoplasms	D003110	—	C18	10	24	15	1	3	46
Pancreatic ductal carcinoma	D021441	—	—	2	4	3	1	—	10

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Triple negative breast neoplasms	D064726	—	—	11	33	13	—	1	51
Neoplasm metastasis	D009362	EFO_0009708	—	6	28	9	—	1	37
Liver neoplasms	D008113	EFO_1001513	C22.0	8	27	7	—	—	35
Nasopharyngeal neoplasms	D009303	—	—	1	17	12	—	1	31
Biliary tract neoplasms	D001661	—	C24.9	6	22	5	—	1	30
Cholangiocarcinoma	D018281	—	C22.1	6	21	6	—	3	30
Nasopharyngeal carcinoma	D000077274	—	—	—	12	17	—	1	30
Renal cell carcinoma	D002292	EFO_0000376	—	14	16	2	—	1	29
Esophageal squamous cell carcinoma	D000077277	—	—	3	11	7	—	—	21
Gallbladder neoplasms	D005706	EFO_0004606	C23	3	13	5	—	1	20

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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	—	—	1	15
Prostatic neoplasms	D011471	—	C61	3	4	—	—	—	7
Immunotherapy	D007167	—	—	1	7	—	—	—	7
Bile duct neoplasms	D001650	—	—	3	6	—	—	—	7
Uterine cervical neoplasms	D002583	HP_0030159	—	2	4	—	—	—	6
Lung neoplasms	D008175	HP_0100526	C34.90	2	3	—	—	—	5
Non-hodgkin lymphoma	D008228	—	C85.9	4	2	—	—	—	4
Glioblastoma	D005909	EFO_0000515	—	3	3	—	—	—	4
Neuroendocrine carcinoma	D018278	—	—	—	4	—	—	—	4
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	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
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
Anemia	D000740	HP_0001903	D64.9	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Prognosis	D011379	—	—	—	—	—	—	2	2
Long qt syndrome	D008133	HP_0001657	I45.81	—	—	—	—	1	1
Torsades de pointes	D016171	EFO_0005307	I47.21	—	—	—	—	1	1
Weight loss	D015431	HP_0001824	—	—	—	—	—	1	1
Gastrointestinal microbiome	D000069196	—	—	—	—	—	—	1	1
Microbiota	D064307	—	—	—	—	—	—	1	1
Pharmacokinetics	D010599	—	—	—	—	—	—	1	1
Fatal outcome	D017809	—	—	—	—	—	—	1	1
Stents	D015607	—	—	—	—	—	—	1	1
Oral administration	D000284	—	—	—	—	—	—	1	1

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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