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Capecitabine Pill
Capecitabine Pill is a Fluoropyrimidine antimetabolite Small molecule drug developed by Peter MacCallum Cancer Centre, Australia. It is currently in Phase 2 development for Metastatic colorectal cancer, Metastatic breast cancer, Gastric cancer. Also known as: Xeloda.
Capecitabine is a prodrug that is converted to fluorouracil in tumor tissue, where it inhibits thymidylate synthase and gets incorporated into DNA and RNA to disrupt cancer cell growth.
Capecitabine is a prodrug that is converted to fluorouracil in tumor tissue, where it inhibits thymidylate synthase and gets incorporated into DNA and RNA to disrupt cancer cell growth. Used for Metastatic colorectal cancer, Metastatic breast cancer, Gastric cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Capecitabine Pill |
|---|---|
| Also known as | Xeloda |
| Sponsor | Peter MacCallum Cancer Centre, Australia |
| Drug class | Fluoropyrimidine antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Capecitabine is an oral fluoropyrimidine carbamate that undergoes hepatic and tissue-level enzymatic conversion to 5-fluorouracil (5-FU). Once activated, it inhibits thymidylate synthase, blocking dTMP synthesis and DNA replication, while also incorporating into RNA to disrupt protein synthesis. This mechanism preferentially affects rapidly dividing cancer cells.
Approved indications
- Metastatic colorectal cancer
- Metastatic breast cancer
- Gastric cancer
Common side effects
- Hand-foot skin reaction
- Diarrhea
- Nausea
- Vomiting
- Fatigue
- Neutropenia
- Thrombocytopenia
Key clinical trials
- Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer (PHASE2)
- Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer (PHASE2)
- LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib (PHASE3)
- Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer (NA)
- A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer (PHASE3)
- Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks (PHASE3)
- Avelumab With Chemoradiation in Locally Advanced Rectal Cancer (PHASE2)
- Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Capecitabine Pill CI brief — competitive landscape report
- Capecitabine Pill updates RSS · CI watch RSS
- Peter MacCallum Cancer Centre, Australia portfolio CI
Frequently asked questions about Capecitabine Pill
What is Capecitabine Pill?
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Related
- Drug class: All Fluoropyrimidine antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: Peter MacCallum Cancer Centre, Australia — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Metastatic breast cancer
- Indication: Drugs for Gastric cancer
- Also known as: Xeloda
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing