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Capecitabine monotherapy — Competitive Intelligence Brief

Capecitabine monotherapy (Capecitabine monotherapy) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Fluoropyrimidine antimetabolite. Area: Oncology.

phase 3 Fluoropyrimidine antimetabolite Thymidylate synthase Oncology Small molecule Live · refreshed every 30 min

Target snapshot

Capecitabine monotherapy (Capecitabine monotherapy) — Zhen-Hai Lu. 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.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Capecitabine monotherapy TARGET Capecitabine monotherapy Zhen-Hai Lu phase 3 Fluoropyrimidine antimetabolite Thymidylate synthase
Xeloda capecitabine Cheplapharm marketed Nucleoside Metabolic Inhibitor [EPC] Thymidylate synthase 1998-01-01
Fudr FLOXURIDINE marketed Antimetabolite [EPC] Thymidylate synthase 1970-01-01
Folic Acid FOLIC ACID Pfizer marketed Vitamin C [EPC] Thymidylate synthase 1946-01-01
Irinotecan, 5FU, leucovorin Irinotecan, 5FU, leucovorin Asan Medical Center marketed Chemotherapy combination (topoisomerase I inhibitor + antimetabolite) Topoisomerase I; thymidylate synthase
S-1 S-1 TTY Biopharm marketed Antimetabolite; fluoropyrimidine combination Thymidylate synthase
Unitrim BRODIMOPRIM marketed brodimoprim Bifunctional dihydrofolate reductase-thymidylate synthase, Dihydrofolate reductase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Fluoropyrimidine antimetabolite class)

  1. Federation Francophone de Cancerologie Digestive · 2 drugs in this class
  2. National Cancer Center, Korea · 2 drugs in this class
  3. Hoffmann-La Roche · 1 drug in this class
  4. Japan Clinical Oncology Group · 1 drug in this class
  5. Jiangxi Provincial Cancer Hospital · 1 drug in this class
  6. Peter MacCallum Cancer Centre, Australia · 1 drug in this class
  7. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 1 drug in this class
  8. Taiho Pharmaceutical Co., Ltd. · 1 drug in this class
  9. The First Affiliated Hospital of Henan University of Science and Technology · 1 drug in this class
  10. UNICANCER · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Capecitabine monotherapy — Competitive Intelligence Brief. https://druglandscape.com/ci/capecitabine-monotherapy. Accessed 2026-05-16.

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