Last update 15 Jul 2025

Capecitabine

Overview

Basic Info

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)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (30 Apr 1998),
RegulationAccelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC15H22FN3O6
InChIKeyGAGWJHPBXLXJQN-UORFTKCHSA-N
CAS Registry154361-50-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ER-positive/HER2-negative Breast CancerPhase 3
France
11 Jun 2020
GRPR Positive/ER Positive/HER2 Negative Breast CancerPhase 3
France
11 Jun 2020
Liver metastasesPhase 3
France
11 Jun 2020
Metastatic gastric adenocarcinomaPhase 3
United States
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
Japan
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
Argentina
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
Belgium
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
Canada
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
Czechia
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
Denmark
20 Jan 2015
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Clinical Result

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