oral administration of S-1 — Competitive Intelligence Brief

oral administration of S-1 (oral administration of S-1) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Fluoropyrimidine antimetabolite. Area: Oncology.

phase 3 Fluoropyrimidine antimetabolite Thymidylate synthase, dihydropyrimidine dehydrogenase Oncology Small molecule

Target snapshot

oral administration of S-1 (oral administration of S-1) — Japan Clinical Oncology Group. S-1 is an oral combination of tegafur, gimeracil, and oteracil that inhibits thymidylate synthase and fluorodeoxyuridylate synthase to block DNA synthesis in cancer cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
oral administration of S-1 TARGET	oral administration of S-1	Japan Clinical Oncology Group	phase 3	Fluoropyrimidine antimetabolite	Thymidylate synthase, dihydropyrimidine dehydrogenase
Placebo plus S1	Placebo plus S1	Chinese PLA General Hospital	marketed	Fluoropyrimidine antimetabolite	Thymidylate synthase, dihydropyrimidine dehydrogenase
Capecitabine (Xeloda®)	Capecitabine (Xeloda®)	National Cancer Center, Korea	marketed	Fluoropyrimidine antimetabolite	Thymidylate synthase
Capecitabine tablets	Capecitabine tablets	UNICANCER	marketed	Fluoropyrimidine antimetabolite	Thymidylate synthase
XELODA [capecitabine]	XELODA [capecitabine]	Hoffmann-La Roche	marketed	Fluoropyrimidine antimetabolite	Thymidylate synthase
Mitomycin and doxifluridine	Mitomycin and doxifluridine	Asan Medical Center	phase 3	Chemotherapy combination (alkylating agent + fluoropyrimidine antimetabolite)	DNA (mitomycin); thymidylate synthase and nucleotide metabolism (doxifluridine)
S-1 and cisplatin	S-1 and cisplatin	Asan Medical Center	phase 3	Fluoropyrimidine antimetabolite + platinum-based alkylating agent	Thymidylate synthase (S-1); DNA (cisplatin)

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