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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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Capecitabine (discontinued: Capecitabine, Xeloda)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Capecitabine

Tradename	Company	Number	Date	Products
XELODA	CHEPLAPHARM Arzneimittel	N-020896 DISCN	1998-04-30	2 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
capecitabine	ANDA	2026-02-03
capecitabine 150mg	ANDA	2020-12-22
capecitabine 500mg	ANDA	2020-12-26
capecitabine tablets, 150 mg capecitabine tablets, 500 mg	Export only	2019-04-21
xeloda	New Drug Application	2026-02-05

Indications

FDA

EMA

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

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

2672 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	99	301	159	10	63	572
Colorectal neoplasms	D015179	—	—	96	308	103	17	47	504
Rectal neoplasms	D012004	—	—	55	225	79	5	59	393
Stomach neoplasms	D013274	EFO_0003897	C16	58	195	80	2	24	321
Neoplasms	D009369	—	C80	132	111	33	1	23	258
Pancreatic neoplasms	D010190	EFO_0003860	C25	69	127	28	4	15	206
Neoplasm metastasis	D009362	EFO_0009708	—	41	107	40	4	3	164
Adenocarcinoma	D000230	—	—	28	103	37	3	12	163
Colonic neoplasms	D003110	—	C18	22	67	42	4	11	130
Triple negative breast neoplasms	D064726	—	—	16	57	29	1	4	96

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	14	41	19	—	3	67
Cholangiocarcinoma	D018281	—	C22.1	11	37	12	—	6	60
Nasopharyngeal carcinoma	D000077274	—	—	1	27	29	—	3	60
Nasopharyngeal neoplasms	D009303	—	—	1	29	23	—	3	56
Biliary tract neoplasms	D001661	—	C24.9	10	31	8	—	6	48
Renal cell carcinoma	D002292	EFO_0000376	—	15	24	2	—	1	38
Gallbladder neoplasms	D005706	EFO_0004606	C23	4	21	9	—	2	33
Gastrointestinal neoplasms	D005770	—	C26.9	7	16	4	—	8	32
Esophageal squamous cell carcinoma	D000077277	—	—	4	19	11	—	—	31
Neoadjuvant therapy	D020360	—	—	1	14	6	—	9	29

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Prostatic neoplasms	D011471	—	C61	7	4	—	—	—	11
Unknown primary neoplasms	D009382	—	—	3	6	—	—	—	8
Ovarian epithelial carcinoma	D000077216	—	—	4	4	—	—	—	7
Residual neoplasm	D018365	—	—	2	3	—	—	3	7
Uterine cervical neoplasms	D002583	—	—	3	4	—	—	—	7
Lung neoplasms	D008175	—	C34.90	3	4	—	—	—	7
Neuroendocrine carcinoma	D018278	—	—	—	6	—	—	—	6
Kidney neoplasms	D007680	EFO_0003865	C64	1	5	—	—	—	6
Glioblastoma	D005909	EFO_0000515	—	3	4	—	—	—	5
Somatostatinoma	D013005	—	—	1	4	—	—	—	5

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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
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
Oncogenes	D009857	—	—	1	—	—	—	1	2
Vaginal neoplasms	D014625	—	C52	2	—	—	—	—	2
Myelodysplastic syndromes	D009190	—	D46	1	—	—	—	—	1
Myeloid leukemia acute	D015470	—	C92.0	1	—	—	—	—	1
Hematologic neoplasms	D019337	—	—	1	—	—	—	—	1
Myeloproliferative disorders	D009196	—	D47.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Prognosis	D011379	—	—	—	—	—	—	2	2
Lymphatic metastasis	D008207	EFO_1001364	—	—	—	—	—	2	2
Electroacupuncture	D015671	—	—	—	—	—	—	2	2
Long qt syndrome	D008133	HP_0001657	I45.81	—	—	—	—	1	1
Torsades de pointes	D016171	EFO_0005307	I47.21	—	—	—	—	1	1
Body weight	D001835	EFO_0004338	—	—	—	—	—	1	1
Weight loss	D015431	—	—	—	—	—	—	1	1
Gastrointestinal microbiome	D000069196	—	—	—	—	—	—	1	1
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Microbiota	D064307	—	—	—	—	—	—	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