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5-flourouracil — Competitive Intelligence Brief

5-flourouracil (5-flourouracil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: pyrimidine analog. Area: Oncology.

phase 2 pyrimidine analog thymidylate synthase Oncology Small molecule Live · refreshed every 30 min

Target snapshot

5-flourouracil (5-flourouracil) — AstraZeneca. 5-fluorouracil is a thymidylate synthase inhibitor that disrupts DNA synthesis in rapidly dividing cancer cells.

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
5-flourouracil TARGET 5-flourouracil AstraZeneca phase 2 pyrimidine analog 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
5-Fluouracil 5-Fluouracil Hoffmann-La Roche marketed Antimetabolite Thymidylate synthase; RNA and DNA incorporation
Capecitabine tablets Capecitabine tablets UNICANCER marketed Fluoropyrimidine antimetabolite Thymidylate synthase
Irinotecan, 5FU, leucovorin Irinotecan, 5FU, leucovorin Asan Medical Center marketed Chemotherapy combination (topoisomerase I inhibitor + antimetabolite) Topoisomerase I; thymidylate synthase

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 (pyrimidine analog class)

  1. AstraZeneca · 1 drug in this class
  2. China Medical University, China · 1 drug in this class
  3. Grupo Espanol de Tumores Neuroendocrinos · 1 drug in this class
  4. Japan Clinical Oncology Group · 1 drug in this class
  5. Servicio de Salud Metropolitano Sur Oriente · 1 drug in this class
  6. UNICANCER · 1 drug in this class

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Cite this brief

Drug Landscape (2026). 5-flourouracil — Competitive Intelligence Brief. https://druglandscape.com/ci/5-flourouracil. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing