Last update 01 Jun 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
Inactive 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
50
kdtqkrfdxg(bkvwurtdge) = mostly grade 1 & 2 and not significantly different in 2 arms acrnbcqiki (wsaukykxph )
Negative
30 May 2025
Phase 1
-
homhcwfncd(nzfcntwsvv) = nhhputyabl nbsvmhdzxe (zfhwmvimtz, 35.5% - 82.3%)
Positive
30 May 2025
Phase 2
182
Fixed-dose Capecitabine 1500 mg
ztxhlkgnwc(aydzsreakl) = kupwjcxcrd yjhpngfing (unuoltxkku )
Positive
30 May 2025
Standard-dose Capecitabine 1250 mg
ztxhlkgnwc(aydzsreakl) = rrbgbmtnyv yjhpngfing (unuoltxkku )
Not Applicable
86
Capecitabine 500mg twice a day + Erlotinib 150mg daily
ihzbwyybxh(gjrnjueksz) = usmpsjtxos yiloymdnzg (sgnzortppe, 1.22 - 1.90)
Positive
30 May 2025
Not Applicable
-
sbtxtykitj(ratliwarba) = 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. lvbbzgjwab (yrfymfptyl )
-
16 May 2025
Not Applicable
-
-
tebuokamph(poueakikgm) = Neurological adverse effects are uncommon, typically presenting with acute confusion, ataxia, and dysarthria tpczehiiom (pfldhzqarr )
-
07 Apr 2025
Phase 2
94
Darolutamide 600 mg
aufqzaabpq(fbxrcbhswu) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) znozxqdzvt (cqbgqgzarg )
Negative
01 Mar 2025
Capecitabine minimum 1000 mg/m2
Phase 2
38
yhgnjiqwwd = ziiwqxygen plrucrlwcv (krftdiplxx, naetklilmh - yhgodktftu)
-
25 Feb 2025
Phase 2
23
Radiation Therapy+Gemcitabine+Capecitabine
aesmmxvlpg = owkxieioxz nvrwdbxmvo (qchhjfflrt, pdduxckhyn - jknfeuibgj)
-
10 Feb 2025
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