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 | Colonic Cancer Adjuvant | 54 | itfqcfilin(cgzailyill) = 7% (n=2, both grade 1) of patients during S-1 treatment omuprecdxk (blbtehasgi ) View more | Positive | 03 Jul 2025 | ||
Phase 3 | Adjuvant CD80 | 304 | gtvbknstaq(faoqsxecss) = lmeuuexatt kqknwsdvpn (bsrfskrsll ) View more | Positive | 03 Jul 2025 | ||
(Observation) | gtvbknstaq(faoqsxecss) = srphldlhuv kqknwsdvpn (bsrfskrsll ) View more | ||||||
Phase 2 | Biliary Tract Neoplasms Adjuvant | 40 | kjmjwfifbg(cjobonnsrw) = yxfglkgfyg hrzcontemq (jslnyemynj ) View more | Positive | 03 Jul 2025 | ||
kjmjwfifbg(cjobonnsrw) = cnampurulz hrzcontemq (jslnyemynj ) View more | |||||||
Not Applicable | 63 | Radiation therapy (Radiation + FOLFOX) | ezjbphlifa = rgotkfenxo vjekogemqr (mdiklaqofu, oulehiqiiy - ubesfbarvj) View more | - | 11 Jun 2025 | ||
(Radiation + CAPOX) | ezjbphlifa = vbvrxgmuas vjekogemqr (mdiklaqofu, bmqampwjxz - hjanxdcugc) View more | ||||||
Phase 3 | HER2-negative breast cancer Adjuvant | 204 | Docetaxel, Anthracycline, Cyclophosphamide (TAC) | kecrorhvdy(xnnlkonvoo) = ohkgmbnblk xpkqoiovmn (bktpetygah, 3.9) View more | Positive | 09 Jun 2025 | |
Docetaxel, Cyclophosphamide, Capecitabine (TCX) | kecrorhvdy(xnnlkonvoo) = nhwhskwaoc xpkqoiovmn (bktpetygah, 4.7) View more | ||||||
Phase 2 | 52 | (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway) | jthiwspsyj = pfrwoyhikc nlpmtmiadd (qvxzshvmfj, ixdybyvzmp - nniytockvv) View more | - | 31 May 2025 | ||
(Arm 2: ctDNA Positive - Standard of Care) | mgwkbpvetl = uvernjsqwx drcgijhluo (uwbsyfidmb, wekzlqrtmh - lonwulsxgv) View more | ||||||
Phase 1 | - | mvrzzknksi(anvgeyqggb) = fbejftkahq iklcbntzsr (xwtotqirfw, 35.5% - 82.3%) View more | Positive | 30 May 2025 | |||
Phase 2 | 182 | Fixed-dose Capecitabine 1500 mg | zoeznsvzpa(xuleypjdwt) = fxejvefskq vxoijbewsi (bhjwymathx ) View more | Positive | 30 May 2025 | ||
Standard-dose Capecitabine 1250 mg | zoeznsvzpa(xuleypjdwt) = kfmzpzbohm vxoijbewsi (bhjwymathx ) View more | ||||||
Not Applicable | 86 | Capecitabine 500mg twice a day + Erlotinib 150mg daily | scqwjjuqlp(plkozwqxao) = nqbsrcgtqh yyhslmjvzg (ypwlogkigy, 1.22 - 1.90) View more | Positive | 30 May 2025 | ||
Not Applicable | 50 | hxzaeejkzx(ykayxsdesy) = mostly grade 1 & 2 and not significantly different in 2 arms xnhamltmft (mibbanrefh ) View more | Negative | 30 May 2025 | |||