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Irinotecan/Tegafur — Competitive Intelligence Brief

Irinotecan/Tegafur (Irinotecan/Tegafur) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Topoisomerase I inhibitor + Fluoropyrimidine antimetabolite combination. Area: Oncology.

phase 3 Topoisomerase I inhibitor + Fluoropyrimidine antimetabolite combination Topoisomerase I; Thymidylate synthase Oncology Small molecule Live · refreshed every 30 min

Target snapshot

Irinotecan/Tegafur (Irinotecan/Tegafur) — Sunshine Lake Pharma Co., Ltd.. Irinotecan inhibits topoisomerase I to prevent DNA unwinding during replication, while tegafur is a prodrug of fluorouracil that inhibits thymidylate synthase to disrupt nucleotide synthesis.

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
Irinotecan/Tegafur TARGET Irinotecan/Tegafur Sunshine Lake Pharma Co., Ltd. phase 3 Topoisomerase I inhibitor + Fluoropyrimidine antimetabolite combination Topoisomerase I; Thymidylate synthase
Irinotecan, 5FU, leucovorin Irinotecan, 5FU, leucovorin Asan Medical Center marketed Chemotherapy combination (topoisomerase I inhibitor + antimetabolite) Topoisomerase I; thymidylate synthase
Irinotecan liposome、5-Fluorouracil、Leucovorin Irinotecan liposome、5-Fluorouracil、Leucovorin Jiangsu HengRui Medicine Co., Ltd. phase 3 Combination chemotherapy (topoisomerase I inhibitor + antimetabolite) Topoisomerase I; thymidylate synthase
Irinotecan + 5 FU + folinic acid Irinotecan + 5 FU + folinic acid Pfizer phase 3 Combination chemotherapy (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 (Topoisomerase I inhibitor + Fluoropyrimidine antimetabolite combination class)

  1. Sunshine Lake Pharma Co., Ltd. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Irinotecan/Tegafur — Competitive Intelligence Brief. https://druglandscape.com/ci/irinotecan-tegafur. Accessed 2026-06-10.

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