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Fluorouracil 0.5% — Competitive Intelligence Brief

Fluorouracil 0.5% (Fluorouracil 0.5%) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antimetabolite, pyrimidine analog. Area: Oncology; Dermatology.

marketed Antimetabolite, pyrimidine analog Thymidylate synthase; RNA and DNA incorporation Oncology; Dermatology Small molecule Live · refreshed every 30 min

Target snapshot

Fluorouracil 0.5% (Fluorouracil 0.5%) — Wake Forest University. Fluorouracil is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis and cell division.

Comparator set (3 drugs)

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

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Fluorouracil 0.5% TARGET Fluorouracil 0.5% Wake Forest University marketed Antimetabolite, pyrimidine analog Thymidylate synthase; RNA and DNA incorporation
5-fluoro-uracil 5-fluoro-uracil UNICANCER marketed Antimetabolite Thymidylate synthase; RNA and DNA incorporation
5-Fluorouracile 5-Fluorouracile Groupe Oncologie Radiotherapie Tete et Cou marketed Antimetabolite; pyrimidine analog Thymidylate synthase; RNA and DNA incorporation
5-Fluouracil 5-Fluouracil Hoffmann-La Roche marketed Antimetabolite Thymidylate synthase; RNA and DNA incorporation

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 (Antimetabolite, pyrimidine analog class)

  1. Wake Forest University · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Fluorouracil 0.5% — Competitive Intelligence Brief. https://druglandscape.com/ci/fluorouracil-0-5. Accessed 2026-06-10.

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