Data updated: May 26, 2026
XELODA (capecitabine)
Trial Activity: Stable 320 active trials
Oncology
Approved 1998-04-30
Development Insights
Fudan University conducting 29 trials (4%)
963 indications explored (Broad Platform)
→ breast cancer (70 trials)
→ gastric cancer (64 trials)
→ colorectal cancer (45 trials)
7
Indications
--
Phase 3 Trials
3
Priority Reviews
28
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-04-30
- Routes
- ORAL
- Dosage Forms
- TABLET
XELODA Approval History
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 1998 to 2025 · 6 indication expansions
Dec 2015 SUPPL Priority
Mfg
Jan 2015 SUPPL Priority
Mfg
Jul 2014 SUPPL Priority
Mfg
Mar 2000 SUPPL
Label
Aug 1999 SUPPL Priority
Mfg
Apr 1999 SUPPL
Label
Feb 1999 SUPPL Priority
Mfg
What XELODA Treats
7 FDA approvalsOriginally approved for its first indication in 1998 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Apr 1998) PriorityLabel Letter
- • Approved indication (Apr 2001)Letter
- • Approved indication (Sep 2001) PriorityLabel Letter
- • Approved indication (Jun 2005)Label Letter
- • Approved indication (Feb 2011)Label Letter
- • Approved indication (Dec 2013) PriorityLabel Letter
- • Approved indication (Dec 2022)Label Letter
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Clinical Trial Registry
721 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05803382 | NCI-2023-02652 NCI-2023-02652, HCC 23-096 | Ph 1 | recruiting | Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers |
| NCT04379596 DG-03 | D967LC00001 2019-004483-22 | Ph 2 | recruiting | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) |
| NCT04929028 | NCI-2021-06041 NCI-2021-06041, AMC-110 | Ph 2 | active not recruiting | Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer |
| NCT07365592 Neo-CD | SAHZU Jun LI | Ph 1, Ph 2 | recruiting | Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC |
| NCT05836584 | NCI-2023-03192 NCI-2023-03192, EA2212 | Ph 2 | active not recruiting | Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer |
| NCT07113275 | XHZDZLK | Ph 3 | recruiting | A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer |
| NCT03907475 | NCI-2019-01886 NCI-2019-01886, 10292 | Ph 2 | recruiting | Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial |
| NCT07582315 | BL-B01D1-317 | Ph 3 | not yet recruiting | A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01) |
| NCT06764875 | D702AC00001 2024-512583-57-00 | Ph 3 | recruiting | A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer |
| NCT02445391 results posted | EA1131 NCI-2014-01820, EA1131 | Ph 3 | active not recruiting | Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy |
| NCT07580339 | J2652 IRB00536619 | Ph 2 | not yet recruiting | Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer |
| NCT06205485 NEO-RT | CCTG-CO32 CCTG-CO32, NCI-2023-10515 | Ph 3 | recruiting | Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer |
| NCT07413939 BREnnA | WO46069 2025-524498-17-00 | Ph 2, Ph 3 | recruiting | RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive |
| NCT07043400 | BGB-A317-316 2025-522862-58-00 | Ph 3 | recruiting | A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma |
| NCT06525766 | MC230303 NCI-2024-06184, 23-009851 | Ph 2 | recruiting | Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer |
| NCT07554521 | BGB-A317-217 | Ph 2 | recruiting | A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States |
| NCT06279364 | SKB264-Ⅲ-11 | Ph 3 | recruiting | A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer |
| NCT07060807 | 1022-016 U1111-1317-5490, 2025-520582-51-00 | Ph 3 | recruiting | A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) |
| NCT07071337 | SKB264-Ⅲ-13 | Ph 3 | recruiting | A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy |
| NCT05568095 STAR-221 | STAR-221 jRCT2051220179, MOH_2023-04-30_012590 | Ph 3 | active not recruiting | A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body |
| NCT04864067 NOAHS-ARC | FONDECYT 11201291 | Ph 2 | completed | No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer |
| NCT06081959 | SKB264-Ⅲ-10 | Ph 3 | recruiting | Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer |
| NCT06966700 | 2870-032 U1111-1316-7898, 2024-520190-12-00 | Ph 3 | recruiting | A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) |
| NCT06761417 | NCC5006 | Ph 2 | recruiting | A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults |
| NCT05201859 | 2021-FXY-486 | Ph 2 | active not recruiting | Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma |
| NCT03801876 | NRG-GI006 NCI-2018-03378, NRG-GI006 | Ph 3 | recruiting | Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer |
| NCT03523312 MAIBE | 18-090 | Ph 2 | active not recruiting | Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer |
| NCT07281768 | J25118 IRB00505702 | Ph 2 | not yet recruiting | Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer |
| NCT07570914 | CSPC-TJ-CRC-05 | Ph 2 | not yet recruiting | Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases |
| NCT05365581 | 2138-CL-0101 jRCT2031210644, CTR20241945 | Ph 1 | recruiting | A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer |
| NCT04248452 | EA2183 NCI-2019-06460, EA2183 | Ph 3 | active not recruiting | Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body |
| NCT05104866 results posted | D9268C00001 2023-509631-37-00, 2020-005620-12 | Ph 3 | active not recruiting | A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) |
| NCT07503756 | JS212-005-II-CRC | Ph 2 | recruiting | JS212 Combination Therapies in Metastatic Colorectal Cancer |
| NCT04166318 | EA2182 NCI-2019-02259, EA2182 | Ph 2 | active not recruiting | Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study |
| NCT04034251 results posted | 190129 19-C-0129 | Ph 2 | terminated | Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis |
| NCT06958328 LAP100 | NRG-GI011 NCI-2025-01624, NRG-GI011 | Ph 3 | recruiting | Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer |
| NCT02595424 results posted | EA2142 NCI-2015-00547, EA2142 | Ph 2 | active not recruiting | Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas |
| NCT07562711 CLEAR-02 | 2410-Exp101 U25A20115 | Ph 2 | recruiting | Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer |
| NCT06469944 | 3475-06C MK-3475-06C, KEYMAKER-06C | Ph 1, Ph 2 | recruiting | Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) |
| NCT07561060 TNTIT | TNTIT | Ph 1, Ph 2 | recruiting | Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy |
| NCT06393374 | 2870-012 2023-504962-52-00, U1111-1289-8264 | Ph 3 | recruiting | Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012) |
| NCT07562659 CLEAR-01 | 2410-Exp100 U25A20115 | Ph 2 | recruiting | Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer |
| NCT06926868 | CA244-0008 2024-519871-24, U1111-1316-1533 | Ph 2, Ph 3 | recruiting | A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) |
| NCT01081262 results posted | NCI-2011-02516 NCI-2011-02516, GOG-0241 | Ph 3 | active not recruiting | Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer |
| NCT05633654 | GS-US-595-6184 2024-512279-10 | Ph 3 | recruiting | Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) |
| NCT06324357 | 1479-0012 | Ph 1, Ph 2 | recruiting | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread |
| NCT06901531 LUCERNA | 8951-CL-0305 2024-519773-19, jRCT2031250021 | Ph 3 | recruiting | A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer |
| NCT04662710 results posted | 7902-015 MK-7902-015, E7080-G000-321 | Ph 3 | completed | Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) |
| NCT05867121 | GO44010 2022-502615-11-00 | Ph 1 | active not recruiting | A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010 |
| NCT07551479 TORCH-STAR | FDRT-2025-665-4814 | Ph 3 | not yet recruiting | SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer |
Showing 50 of 721 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XELODA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment