Trifluridine and Tipiracil — Competitive Intelligence Brief

Trifluridine and Tipiracil (Trifluridine and Tipiracil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antimetabolite combination; thymidylate synthase inhibitor. Area: Oncology.

marketed Antimetabolite combination; thymidylate synthase inhibitor Thymidylate synthase; thymidine phosphorylase Oncology Small molecule

Target snapshot

Trifluridine and Tipiracil (Trifluridine and Tipiracil) — Amgen. Trifluridine is a nucleoside analog that inhibits thymidylate synthase and gets incorporated into DNA to damage cancer cells, while tipiracil is a thymidine phosphorylase inhibitor that enhances trifluridine bioavailability.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Trifluridine and Tipiracil TARGET	Trifluridine and Tipiracil	Amgen	marketed	Antimetabolite combination; thymidylate synthase inhibitor	Thymidylate synthase; thymidine phosphorylase
epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile	epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile	Sanofi	phase 3	anthracycline antibiotic, taxane, alkylating agent, antifolate, thymidylate synthase inhibitor	topoisomerase II, microtubules, dihydrofolate reductase, thymidylate synthase
oxaliplatin , fluorouracil, and leucovorin	oxaliplatin , fluorouracil, and leucovorin	Sun Yat-sen University	phase 3	Platinum-based chemotherapeutic agent and thymidylate synthase inhibitor	Thymidylate synthase
capecitabine-irinotecan	capecitabine-irinotecan	Dutch Colorectal Cancer Group	phase 3	Topoisomerase I inhibitor and thymidylate synthase inhibitor	Topoisomerase I and thymidylate synthase
cetuximab, capecitabine	cetuximab, capecitabine	Institute of Oncology Ljubljana	phase 3	EGFR inhibitor, thymidylate synthase inhibitor	EGFR, thymidylate synthase
TAS-118 plus Oxaliplatin	TAS-118 plus Oxaliplatin	Taiho Pharmaceutical Co., Ltd.	phase 3	Thymidylate synthase inhibitor	Thymidylate synthase
docetaxel, nedaplatin, and capecitabine	docetaxel, nedaplatin, and capecitabine	Sun Yat-sen University	phase 3	Taxane, Platinum-based DNA crosslinker, Thymidylate synthase inhibitor	Microtubules, DNA, 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 (Antimetabolite combination; thymidylate synthase inhibitor class)

1. Amgen · 1 drug in this class