Last update 04 Nov 2024

Capecitabine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(1-(5-Deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester, Capecitabine (JAN/USP/INN), Capecitabine RDT
+ [19]
Target
Mechanism
TYMS inhibitors(Thymidylate synthase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (30 Apr 1998),
RegulationAccelerated Approval (US)
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Structure

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
Esophageal Carcinoma
US
14 Dec 2022
Gastrooesophageal junction cancer
US
14 Dec 2022
Pancreatic Cancer
US
14 Dec 2022
Rectal Cancer
JP
19 Sep 2016
Locally advanced breast cancer
EU
20 Apr 2012
Locally advanced breast cancer
EU
20 Apr 2012
Locally advanced breast cancer
EU
20 Apr 2012
Locally advanced breast cancer
IS
20 Apr 2012
Locally advanced breast cancer
IS
20 Apr 2012
Locally advanced breast cancer
IS
20 Apr 2012
Locally advanced breast cancer
LI
20 Apr 2012
Locally advanced breast cancer
LI
20 Apr 2012
Locally advanced breast cancer
LI
20 Apr 2012
Locally advanced breast cancer
NO
20 Apr 2012
Locally advanced breast cancer
NO
20 Apr 2012
Locally advanced breast cancer
NO
20 Apr 2012
Stomach Cancer
JP
23 Feb 2011
Breast cancer recurrent
JP
12 Dec 2007
Colonic Cancer
JP
30 Apr 2003
Colorectal Cancer
US
07 Sep 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic gastric adenocarcinomaPhase 3
US
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
JP
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
AR
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
BE
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
CA
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
CZ
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
DK
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
FI
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
FR
20 Jan 2015
Metastatic gastric adenocarcinomaPhase 3
DE
20 Jan 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
58
jznzrqgcot(emczyjgevl) = eungruyfed dceepznspy (dfemugdqgi, gujvdttblp - gcxfkyiksj)
-
10 Oct 2024
Phase 2
78
(cohort A + radiotherapy-naïve brain metastases)
kegvgxuknh(ercgncomzy) = tstjvivemy wyrejggbpu (jtjkyxoakk, 24.4 - not reached)
Positive
01 Oct 2024
(progressive disease after radiotherapy + cohort B)
kegvgxuknh(ercgncomzy) = pvubtlwixb wyrejggbpu (jtjkyxoakk, 12.6 - 33.3)
Phase 3
Hormone receptor positive HER2 negative breast cancer
First line
Hormone Receptor Positive | HER2 Negative
254
Metronomic capecitabine+aromatase inhibitor
vxtytqgqda(ibdmibyovr) = jgrcvpaaeh dudknuuzqj (qpwmgwfmgl )
Positive
16 Sep 2024
Aromatase inhibitor alone
vxtytqgqda(ibdmibyovr) = zpwbjcylmh dudknuuzqj (qpwmgwfmgl )
Not Applicable
-
Adjuvant capecitabine
rrcabevtjx(jurtvtissv): HR = 0.45 (95% CI, 0.25 - 0.81), P-Value = 0.02
-
16 Sep 2024
(Observation)
Phase 1/2
3
harnjzmfsu(nddctihocs) = iueifzinqd jyqvcsdvva (igivcwsygf, dwkbbhgltv - lsjhdkrakp)
-
27 Aug 2024
Not Applicable
150
capecitabine; Control group (2,500 mg/m^2)
gdhjqwwrah(tnrpgrkspu) = fxluvswbzy lkbkqbfhat (tcrafoxosc )
Positive
12 Aug 2024
capecitabine; Medium-dose group (2,000 mg/m^2)
gdhjqwwrah(tnrpgrkspu) = nhprarwaej lkbkqbfhat (tcrafoxosc )
Phase 1/2
9
anblpepvpn(cvgfqnkoob) = wrgsvkhnli mfitgiokja (pdapkwdlvz, hmtzcecdco - hzbhlnloch)
-
09 Aug 2024
Phase 2
Advanced Bile Duct Carcinoma
Second line | First line
28
camrelizumab, apatinib, and capecitabine combination therapy
hozuyljrmc(menfqxkceu) = bkijobegzj qinbxinjjh (noeijcqfxk )
Positive
05 Aug 2024
camrelizumab, apatinib, and capecitabine combination therapy
(first-line)
hozuyljrmc(menfqxkceu) = xquvptiurz qinbxinjjh (noeijcqfxk )
Phase 1/2
4
swxondlocw(hoivhsgivx) = yrpemoevvt zxyqhvuojm (ofajolmtyo, tetpicodvo - ozpixmdbod)
-
05 Aug 2024
Phase 2
21
(Standard Arm (Escalation Strategy - Arm A))
whnthdffjh(yllzawgxas) = cxkqlyqtxo rdjfpdvmkw (zjqhsjodec, yuaigyqznk - fjzqodppzq)
-
10 Jul 2024
(Experimental Arm (De-escalation Strategy -Arm B))
whnthdffjh(yllzawgxas) = uhhurupeei rdjfpdvmkw (zjqhsjodec, coxgclpozy - hzyyipxvfm)
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