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.

health-canada-dpdRegulatory47 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as CAPECITABINE (DIN 02519887) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 16, 2022	health-canada-dpd
CA

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 2 days 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	354	183	329	1,352	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	46	22	21	124	1	US	Apr 30, 1998	2000-10
Malignant Pancreatic Neoplasm	Approved	Phase 3	17	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 (1,384)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 1,384 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
NCT03653507	A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).(GLOW)	active not recruiting	Phase 3	507	Astellas Pharma Global Development, Inc.INDUSTRY	18	Sep 28, 2026	clinicaltrials
NCT03734029

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)

BRAF V600E3
Bevacizumab + Capecitabine + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	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	D	Supports Sensitivity Response	3	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	B	Supports Resistance	3	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

ERBB2 Overexpression2
Capecitabine + TrastuzumabCombination	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	4	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	C	Supports Sensitivity Response	3	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