NDAORALTABLETPriority Review
Approved
Apr 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
XELODA (capecitabine) by Hetero is nucleic acid synthesis inhibitors [moa]. Approved for breast cancer, colorectal cancer. First approved in 1998.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XELODA (capecitabine) is an oral nucleoside metabolic inhibitor that converts to fluorouracil in tumor tissue, disrupting nucleic acid synthesis. It treats multiple solid tumors including breast, colorectal, gastric, pancreatic, and biliary tract cancers. The drug functions as a prodrug activated by tissue-specific enzymes, enabling oral delivery of a traditional chemotherapy agent.
$0.008BPart D
LOE ApproachingDeclining
Low commercial momentum with minimal branded sales and approaching generic entry; expect reduced team investment and focus shift toward managed care and cost containment.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications (2)
Clinical Trials (20)
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
Started May 2026
66 enrolled
Colorectal Cancer
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
Started Apr 2026
650 enrolled
HER2-positive Breast Cancer
Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance
Started Apr 2026
29 enrolled
Rectal Cancer
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
Started Feb 2026
2,130 enrolled
Gastric CancerGastroesophageal Junction AdenocarcinomaEsophageal Cancer
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Started Jan 2026
297 enrolled
Estrogen-receptor-positive Breast CancerMetastatic Breast CancerBreast Cancer+6 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.