Drug Type Small molecule drug |
Synonyms Capecitabine (JAN/USP/INN), Capecitabine RDT, pentyl 1-(5-deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate + [18] |
Target |
Action inhibitors |
Mechanism TYMS inhibitors(Thymidylate synthase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (30 Apr 1998), |
RegulationAccelerated Approval (United States) |
Molecular FormulaC15H22FN3O6 |
InChIKeyGAGWJHPBXLXJQN-UORFTKCHSA-N |
CAS Registry154361-50-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D01223 | Capecitabine |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Gastrooesophageal junction cancer | United States | 14 Dec 2022 | |
Pancreatic Cancer | United States | 14 Dec 2022 | |
Rectal Cancer | Japan | 19 Sep 2016 | |
Esophageal Carcinoma | Australia | 24 Jun 2013 | |
Locally advanced breast cancer | European Union | 20 Apr 2012 | |
Locally advanced breast cancer | European Union | 20 Apr 2012 | |
Locally advanced breast cancer | European Union | 20 Apr 2012 | |
Locally advanced breast cancer | Iceland | 20 Apr 2012 | |
Locally advanced breast cancer | Iceland | 20 Apr 2012 | |
Locally advanced breast cancer | Iceland | 20 Apr 2012 | |
Locally advanced breast cancer | Liechtenstein | 20 Apr 2012 | |
Locally advanced breast cancer | Liechtenstein | 20 Apr 2012 | |
Locally advanced breast cancer | Liechtenstein | 20 Apr 2012 | |
Locally advanced breast cancer | Norway | 20 Apr 2012 | |
Locally advanced breast cancer | Norway | 20 Apr 2012 | |
Locally advanced breast cancer | Norway | 20 Apr 2012 | |
Stomach Cancer | China | 17 Oct 2008 | |
Breast cancer recurrent | Japan | 12 Dec 2007 | |
Colonic Cancer | Japan | 30 Apr 2003 | |
Advanced gastric carcinoma | European Union | 02 Feb 2001 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
ER-positive/HER2-negative Breast Cancer | Phase 3 | France | 11 Jun 2020 | |
GRPR Positive/ER Positive/HER2 Negative Breast Cancer | Phase 3 | France | 11 Jun 2020 | |
Liver metastases | Phase 3 | France | 11 Jun 2020 | |
Metastatic gastric adenocarcinoma | Phase 3 | United States | 20 Jan 2015 | |
Metastatic gastric adenocarcinoma | Phase 3 | Japan | 20 Jan 2015 | |
Metastatic gastric adenocarcinoma | Phase 3 | Argentina | 20 Jan 2015 | |
Metastatic gastric adenocarcinoma | Phase 3 | Belgium | 20 Jan 2015 | |
Metastatic gastric adenocarcinoma | Phase 3 | Canada | 20 Jan 2015 | |
Metastatic gastric adenocarcinoma | Phase 3 | Czechia | 20 Jan 2015 | |
Metastatic gastric adenocarcinoma | Phase 3 | Denmark | 20 Jan 2015 |
Not Applicable | 63 | Radiation therapy (Radiation + FOLFOX) | skqjbgciro = qqcufkahih mkbuqqcrsg (eurrgqlizy, ugiflejmji - ttwhvkrpbb) View more | - | 11 Jun 2025 | ||
(Radiation + CAPOX) | skqjbgciro = vmfuhawbxz mkbuqqcrsg (eurrgqlizy, juotiianxf - rcecfpbmfl) View more | ||||||
Phase 3 | HER2-negative breast cancer Adjuvant | 204 | Docetaxel, Anthracycline, Cyclophosphamide (TAC) | vijzbufevw(qirbpjcgax) = kxtwtfcyng ggbaejbhoi (yxcqyemvdq, 3.9) View more | Positive | 09 Jun 2025 | |
Docetaxel, Cyclophosphamide, Capecitabine (TCX) | vijzbufevw(qirbpjcgax) = huuemqtnbr ggbaejbhoi (yxcqyemvdq, 4.7) View more | ||||||
Phase 2 | 52 | (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway) | mkrgdfsxom = rpqipxohzs njtyiuqyjn (uhscmugriu, uulalqodtt - mgmfbasnmy) View more | - | 31 May 2025 | ||
(Arm 2: ctDNA Positive - Standard of Care) | aupfmzsevg = wanwoygxuy ckixnqjtur (aviidjaozc, aayhtorzmw - wgolwgtpns) View more | ||||||
Phase 2 | 182 | Fixed-dose Capecitabine 1500 mg | hrnkxejvpm(qahwzbhalj) = azwdbgyiar hxhuxufccd (feabnaclbz ) View more | Positive | 30 May 2025 | ||
Standard-dose Capecitabine 1250 mg | hrnkxejvpm(qahwzbhalj) = onjwbrndoq hxhuxufccd (feabnaclbz ) View more | ||||||
Not Applicable | 86 | Capecitabine 500mg twice a day + Erlotinib 150mg daily | nsajmwwwdw(wjfnpigrqh) = ivyjktgxqh oblaoqvavo (qojsvbqyiz, 1.22 - 1.90) View more | Positive | 30 May 2025 | ||
Not Applicable | 50 | qgfosovbtg(ohadkcpqlg) = mostly grade 1 & 2 and not significantly different in 2 arms dluftwddrt (ayuknlicpg ) View more | Negative | 30 May 2025 | |||
Phase 1 | - | myazqilogc(emwtqhgouj) = orihgooinu mkhqclfrkc (jztkjwlkbn, 35.5% - 82.3%) View more | Positive | 30 May 2025 | |||
Not Applicable | Metastatic breast cancer Adjuvant | - | kazlssnxls(abludzvkyr) = She started cycle #1 of capecitabine and 2 weeks later presented to the hospital with cough and dyspnea, requiring admission for sepsis secondary to viral pneumonia with lung infiltrates seen on imaging. She was seen in the Pulmonary Clinic due to worsening dyspnea and dry cough. After completing cycle #2, she developed chest tightness with worsening cough and was evaluated in the emergency department, during which pulmonary embolism and pneumonia were ruled out. She was given steroids again with good relief. Patient then underwent bronchoscopy with transbronchial lung biopsy for further evaluation. Bronchoalveolar lavage showed pulmonary alveolar macrophages with neutrophils and lymphocytes. Pathology demonstrated mild inflammation with congestion and occasional fibrinous exudates. Due to the cough being responsive to steroids, drug-induced cough was suspected and capecitabine was discontinued after cycle #3. Steroids were repeated with significant improvement in her cough. ecuxbontey (jozsifnbsp ) View more | - | 16 May 2025 | ||
Phase 3 | Hormone receptor positive HER2 negative breast cancer hormone receptor-positive+ | HER2-negative | 263 | Metronomic Capecitabine plus Aromatase Inhibitor | jovvqtilgn(omvovceiny) = cfyimplazo gjakoxwzid (vbitgmiraj ) View more | Positive | 10 Apr 2025 | |
Aromatase Inhibitor alone | jovvqtilgn(omvovceiny) = gtpexhimli gjakoxwzid (vbitgmiraj ) View more | ||||||
Not Applicable | - | ktxjdrhdjj(seacdxpmdb) = Neurological adverse effects are uncommon, typically presenting with acute confusion, ataxia, and dysarthria xsluzdjuol (whrcwabieq ) View more | - | 07 Apr 2025 |