Capecitabine
Approved · FDA / EMAAlso known as Xeloda, Capecitabin, Capecitabina, Capécitabine+2 more
Xeloda, Capecitabin, Capecitabina, Capécitabine, (1-(5-Deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester, Capecitabinum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: CAPECITABINE (ANDA210203)
Label change: CAPECITABINE (ANDA211724)
Label change: CAPECITABINE (ANDA202593)
Label change: CAPECITABINE (ANDA202593)
5‑Fluorouracil and capecitabine therapies for the treatment of colorectal cancer (Review).
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is indicated for the… Show full indicationShow less
Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer. Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Medac 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 Medac 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.
Indication: Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer. Capecitabine Teva is indicated for the… Show full indicationShow less
Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer. Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer. Capecitabine Teva is indicated for first?line treatment of advanced gastric cancer in combination with a platinum?based regimen. Capecitabine Teva 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 Teva 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.
Indication: Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Ecansya is indicated for the treatment of metastatic… Show full indicationShow less
Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Ecansya is indicated for the treatment of metastatic colorectal cancer. Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Ecansya 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. Ecansya 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.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology6
- The New England journal of medicine4
- BMC cancer1
- Clinical breast cancer1
- Clinical cancer research : an official journal of the American Association for Cancer Research1
- Journal of nuclear medicine : official publication, Society of Nuclear Medicine1
- Hamilton E3
- Hudis CA3
- Winer EP3
- Abramson V2
- Anders C2
- Bachelot T2
- Baselga J2
- Bedard PL2
- Centro de Pesquisa Clínica Hospital São Lucas da PUCRS2
- Dana-Farber Cancer Institute2
- Hospital Clínico Universitario de Valencia2
- Hospital General Universitario Morales Meseguer2
- Hospital Universitario Virgen del Rocío2
- Instituto de Investigación Sanitaria Gregorio Marañón2
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Acts on the same molecular target as Capecitabine, with 5 overlapping disease areas.
Studied across 5 of the same disease areas as Capecitabine in the shared literature.
Studied across 3 of the same disease areas as Capecitabine in the shared literature.
Studied across 2 of the same disease areas as Capecitabine in the shared literature.
Studied across 2 of the same disease areas as Capecitabine in the shared literature.
Studied across the same disease area as Capecitabine in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.