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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Clinical

Drug

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Variants

Financial

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Events Timeline

YTD

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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

Capecitabine, Xeloda (discontinued: Capecitabine)

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	2025-06-25
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	2025-01-10

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

2533 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	101	313	172	10	66	602
Colorectal neoplasms	D015179	—	—	91	292	101	16	44	479
Rectal neoplasms	D012004	—	—	51	219	65	2	58	367
Stomach neoplasms	D013274	EFO_0003897	C16	50	192	77	3	22	309
Adenocarcinoma	D000230	—	—	56	161	63	4	14	268
Neoplasms	D009369	—	C80	130	103	36	1	23	254
Carcinoma	D002277	—	C80.0	34	119	52	1	11	195
Pancreatic neoplasms	D010190	EFO_0003860	C25	64	123	26	4	13	194
Neoplasm metastasis	D009362	EFO_0009708	—	27	77	28	6	3	118
Esophageal neoplasms	D004938	—	C15	27	65	19	1	9	104

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Nasopharyngeal carcinoma	D000077274	—	—	1	28	28	—	3	60
Cholangiocarcinoma	D018281	—	C22.1	11	36	9	—	7	56
Nasopharyngeal neoplasms	D009303	—	—	1	27	23	—	3	54
Squamous cell carcinoma	D002294	—	—	9	30	10	—	2	49
Biliary tract neoplasms	D001661	—	C24.9	9	33	10	—	4	49
Renal cell carcinoma	D002292	EFO_0000376	—	15	22	2	—	1	36
Hand-foot syndrome	D060831	EFO_1001893	—	2	9	8	—	10	27
Neoadjuvant therapy	D020360	—	—	1	12	6	—	8	26
Esophageal squamous cell carcinoma	D000077277	—	—	3	15	8	—	—	26
Gallbladder neoplasms	D005706	EFO_0004606	C23	2	17	6	—	2	25

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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	6	4	—	—	—	10
Klatskin tumor	D018285	EFO_1001005	—	1	4	—	—	4	9
Neuroendocrine carcinoma	D018278	—	—	1	7	—	—	—	8
Residual neoplasm	D018365	—	—	3	4	—	—	2	8
Disease progression	D018450	—	—	1	3	—	—	2	6
Uterine cervical neoplasms	D002583	—	—	2	4	—	—	—	6
Glioma	D005910	EFO_0000520	—	3	4	—	—	—	6
Ductal carcinoma	D044584	—	—	2	4	—	—	—	6
Islet cell adenoma	D007516	EFO_0007331	D13.7	2	5	—	—	—	6
Kidney neoplasms	D007680	EFO_0003865	C64	2	4	—	—	—	6

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	2	—	—	—	—	2
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
Female genital neoplasms	D005833	—	—	2	—	—	—	—	2
Lip neoplasms	D008048	—	C00	1	—	—	—	1	2
T-cell lymphoma	D016399	—	—	2	—	—	—	—	2
T-cell lymphoma peripheral	D016411	—	—	2	—	—	—	—	2
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
Oncogenes	D009857	—	—	1	—	—	—	1	2

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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
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
Cardiotoxicity	D066126	EFO_1001482	—	—	—	—	—	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