Drug · Small Molecule

Capecitabine

CI-DRUG-00000136Explore in graph →NCIt C1794 CHEMBL1773 CIViC Approved

Regulatory

Approvals (47)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory6 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer. Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	355	183	329	1,354	47	CA, EU, US	Apr 30, 1998	1998-07
Malignant Breast Neoplasm	Approved	Phase 4	73	44	92	309	2	US	Apr 30, 1998	1998-07
Malignant Rectal Neoplasm	Approved	Phase 3	47	22	21	125	1	US	Apr 30, 1998	2000-10
Malignant Pancreatic Neoplasm	Approved	Phase 3	16	6	13	109

Curated evidence

Clinical evidence (18)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–18 of 18 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ERBB2 Amplification7
Capecitabine + Lapatinib

Clinical trials

Trials with this intervention (1,386)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 1,386 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04721977	A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)	active not recruiting	Phase 2	66	PfizerINDUSTRY	3	Sep 10, 2026	clinicaltrials
NCT06797635	Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Molecule

Record

Kind: Small Molecule
Mechanism: Thymidylate synthase inhibitor; DNA inhibitor; RNA inhibitor
Targets: 1 gene
UNII: 6804DJ8Z9U
Aliases: 5'-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine, ACH-CAPECITABINE, APO-CAPECITABINE, Capecitabina, Capecitabine, CAPECITABINE 150MG, CAPECITABINE 500MG, Capecitabine accord, Capecitabine component of xeliri capecitibine, Capecitabine component of xelox, Capecitabine medac, Capecitabine sun, Capecitabine teva, Capecitibine, Capecytabine, Capiibine, Captabin, Ecansya, Ecansya (previously capecitabine krka), MINT-CAPECITABINE, NSC-759853, Ro 09-1978/000, Ro-09-1978-000, RO-09-1978000, RO-091978000, SANDOZ CAPECITABINE, TARO-CAPECITABINE, TEVA-CAPECITABINE, Xeloda, XELODA

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (47)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01BC06	CAPECITABINE
DIN (Health Canada)

PIK3CA Mutation1

Capecitabine + LapatinibCombination

HER2-Positive Breast CarcinomaALIAS

Predictive

Supports Resistance

accepted

EID8705

In a phase 3 clinical trial (NCT00829166), metastatic HER-2 amplified breast cancer patients whose tumors harbored PIK3CA mutations treated with standard of care capecitabine and lapatinib combination… (full text at CIViC)

PMID 26920887 · Baselga et al., 2016 · Open in CIViC

civic

BRAF V600E3

Bevacizumab + Capecitabine + OxaliplatinCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Resistance

accepted

EID2121

In a study of metastatic colorectal cancer patients treated with capecitabine, oxaliplatin, and bevacizumab, those with BRAF V600E mutations had reduced progression-free survival (5.9mo vs. 12.2mo, P=… (full text at CIViC)

PMID 19571295 · Tol et al., 2009 · Open in CIViC

civic

Bevacizumab + Capecitabine + VemurafenibCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID98

This in vivo study examined the efficacy of various treatments on athymic nude mice xenografted with colorectal cancer HT29 cells, which harbor BRAF V600E. The authors sought to understand whether the… (full text at CIViC)

PMID 22180495 · Yang et al., 2012 · Open in CIViC

civic

Bevacizumab + Capecitabine + Cetuximab + OxaliplatinCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Resistance

submitted

EID8646

In a study of metastatic colorectal cancer patients treated with capecitabine, oxaliplatin, bevacizumab, and cetuximab those with BRAF V600E mutations had reduced progression-free survival (6.6mo vs. … (full text at CIViC)

PMID 19571295 · Tol et al., 2009 · Open in CIViC

civic

TP53 Wildtype1

Capecitabine + Cetuximab + OxaliplatinCombination

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID875

In this retrospective biomarker analysis of the EXPERT-C trial, patients with TP53 wild-type status had a statistically significant better progression free survival (PFS) (89.3% vs 65.0% at 5 years; h… (full text at CIViC)

PMID 24957073 · Sclafani et al., 2014 · Open in CIViC

civic

DPYD DPYD*13 HOMOZYGOSITY1

Capecitabine + Fluorouracil + TegafurSubstitutes

Malignant NeoplasmALIAS

Predictive

Supports Adverse Response

accepted

EID1801

The Clinical Pharmacogenomics Implementation Consortium Guidelines for DPYD genotype and 5-FU dosing does not recommend the use of 5-FU or capecitabine in patients with homozygous DPYD*2A, *13 or rs67… (full text at CIViC)

PMID 23988873 · Caudle et al., 2013 · Open in CIViC

civic

DPYD DPYD*2A HOMOZYGOSITY1

Capecitabine + Fluorouracil + TegafurSubstitutes

Malignant NeoplasmALIAS

Predictive

Supports Adverse Response

accepted

EID1800

PMID 23988873 · Caudle et al., 2013 · Open in CIViC

civic

DPYD RS67376798 HOMOZYGOSITY1

Capecitabine + Fluorouracil + TegafurSubstitutes

Malignant NeoplasmALIAS

Predictive

Supports Adverse Response

accepted

EID1803

PMID 23988873 · Caudle et al., 2013 · Open in CIViC

civic

ERBB2 Overexpression2

Capecitabine + TrastuzumabCombination

Malignant Pancreatic Neoplasm

Predictive

Does Not Support Sensitivity Response

accepted

EID5955

This is Phase II trial of Trastuzumab and capecitabine as first line treatment in patients with IHC 3+ HER2 expressing advanced pancreatic cancer or cancer with HER2 gene amplification of stage IVB. T… (full text at CIViC)

PMID 22374460 · Harder et al., 2012 · Open in CIViC

civic

Capecitabine + Trastuzumab + Zoledronic AcidCombination

Malignant Salivary Gland NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID6171

Case report of a a 58 year old man with multiple bone metastases after local therapy of a carcinoma ex pleomorphic adenoma one year earlier. The original tumor tested strongly positive for HER2/neu by… (full text at CIViC)

PMID 20504363 · Sharon et al., 2010 · Open in CIViC

civic

ERBB2 L755S1

Capecitabine + NeratinibCombination

Triple-Negative Breast CarcinomaALIAS

Predictive

Supports Sensitivity Response

submitted

EID8055

This patient originally presented in the clinic with an ER+, PR-, and HER2- mass on the left breast and bone metastasis. Family history showed negative germline mutations in BRCA1/2. Patient responded… (full text at CIViC)

PMID 26358790 · Ben-Baruch et al., 2015 · Open in CIViC

civic