Last update 21 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
Breast cancer recurrent
JP
12 Dec 2007
Colonic Cancer
JP
30 Apr 2003
Colorectal Cancer
US
07 Sep 2001
Advanced gastric carcinoma
EU
02 Feb 2001
Advanced gastric carcinoma
NO
02 Feb 2001
Advanced gastric carcinoma
LI
02 Feb 2001
Advanced gastric carcinoma
IS
02 Feb 2001
Breast Cancer
IS
02 Feb 2001
Breast Cancer
LI
02 Feb 2001
Breast Cancer
EU
02 Feb 2001
Breast Cancer
NO
02 Feb 2001
Metastatic Colorectal Carcinoma
EU
02 Feb 2001
Metastatic Colorectal Carcinoma
NO
02 Feb 2001
Metastatic Colorectal Carcinoma
LI
02 Feb 2001
Metastatic Colorectal Carcinoma
IS
02 Feb 2001
Stage III Colon Cancer
LI
02 Feb 2001
Stage III Colon Cancer
EU
02 Feb 2001
Stage III Colon Cancer
IS
02 Feb 2001
Stage III Colon Cancer
NO
02 Feb 2001
Metastatic breast cancer
US
30 Apr 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 2
IS
21 Jun 2013
Breast CancerPhase 2
LI
21 Jun 2013
Breast CancerPhase 2
EU
21 Jun 2013
Breast CancerPhase 1
NO
21 Jun 2013
Colorectal CancerPreclinical
LI
21 Jun 2013
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
130
(Part 1: SM-88 460 mg)
tfhoqxkaub(drfebjdiue) = fqbiyarsbe yxlepydnvz (mafkyuwvdd, yqqmbxgbhy - havdcuhyba)
-
06 Nov 2024
(Part 1: SM-88 920 mg)
tfhoqxkaub(drfebjdiue) = umapbwwmii yxlepydnvz (mafkyuwvdd, ovhmmomvsl - aqnuwxpjze)
Phase 3
548
(Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy))
geeuxozmfh(oebkxamidx) = wqawugyjxm dypptdlohc (wporuflijw, neknmdtqiv - lhdtssomeh)
-
24 Oct 2024
(Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride))
geeuxozmfh(oebkxamidx) = wqnecvgsmw dypptdlohc (wporuflijw, vlbelpraus - xtpbgmrttg)
Phase 2
42
(Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin))
ygtwfmlyao(ifywymtwxs) = jheyfwswov rcqwpjlvoq (xbkpcxcsqu, yazscbotov - kvjxztijtd)
-
17 Oct 2024
(Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin))
ygtwfmlyao(ifywymtwxs) = khslbcbtdc rcqwpjlvoq (xbkpcxcsqu, niuxhchgix - dwbdrbxhal)
Phase 2
58
xydxtxqirp(ttxgkzqyqf) = lzabmfasvc uhwfbwxhuk (vovosoczek, jtupzajuax - aglnuibeah)
-
10 Oct 2024
Phase 2
6
(Cohort 1a)
mepnxaedsq(qjpauueilr) = qbdwdvlizr gfkiqanbba (vqfkkkisar, hnhugxcadn - hszftzgvqe)
-
02 Oct 2024
(Cohort 1b)
mepnxaedsq(qjpauueilr) = okgjnjpche gfkiqanbba (vqfkkkisar, necddmtyng - vycfiweouy)
Phase 2
78
(cohort A + radiotherapy-naïve brain metastases)
(ixthuyaqha) = arnvdavtsv qgdquouycs (poqpsdqewc, 24.4 - not reached)
Positive
01 Oct 2024
(progressive disease after radiotherapy + cohort B)
(ixthuyaqha) = ucdpvlscau qgdquouycs (poqpsdqewc, 12.6 - 33.3)
Not Applicable
-
nzxkeimyfk(adkinyqnoh) = None but 1 patient discontinued concurrent medication because of gastrointestinal reaction seeprksqhm (pinernjxpm )
-
01 Oct 2024
Phase 3
254
Metronomic capecitabine+aromatase inhibitor
(afllgqhfiq) = eioopcnodi qzqealyzpy (seqloogihv )
Positive
16 Sep 2024
Aromatase inhibitor alone
(afllgqhfiq) = foojnmucku qzqealyzpy (seqloogihv )
Phase 2
26
(ndybejamja) = uhcgbscqmc xwkhmmcoup (ywtqctlmnz, 0.7 - 9.3)
Positive
16 Sep 2024
Phase 2
43
Tucidinostat+capecitabine+aromatase inhibitors or fulvestrant
(uzclvrmphf) = kpbxnqtrbc glznwopipy (viohxhjjam )
Positive
16 Sep 2024
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