Trifluridine-tipiracil

Phase 2Small molecule

Trifluridine-tipiracil is one of 70 small molecule programs targeting Advanced Microsatellite Stable Colorectal Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced Microsatellite Stable Colorectal CancerRecruiting

Intestinal CancerRecruiting

Solid TumorTerminated

Advanced Microsatellite Stable Colorectal CancerPhase 2

Recruiting

Intestinal CancerPhase 2

Recruiting

Solid TumorPhase 1

Terminated

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Trifluridine-tipiracil

Merck & Co.

Phase 2

3 2

Fludara

Sanofi

Preclinical

1 3

DATROWAY

Daiichi Sankyo

Preclinical

1 4

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 5

Epivir

GGlaxo Dba Glaxosmithkline

Preclinical

1 6

Navmi

SSummit Therapeutics

Preclinical

1 7

PD-1 Inhibitor

Johnson & Johnson

Preclinical

1 8

Tulmimetostat

Novartis

Preclinical

1 9

Soc

Pfizer

Preclinical

1 10

Sacituzumab Govitecan-Hziy

Gilead

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

PreclinicalActive, not recruiting

Solid Tumor

NCT04626635

Q2 2027

Phase 3Active, not recruiting

Esophageal Adenocarcinoma

NCT06356311

Q4 2028

Phase 2Recruiting

Advanced Microsatellite Stable Colorectal Cancer

NCT07527858

Phase 1/2Recruiting

Intestinal Cancer

NCT07280377

Q4 2029

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06887218

Clinical

Trials by Indication[1]

Solid Tumor3 trials

A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Terminated· Astellas logo

Astellas·Phase 1·NCT05083481·226 enrolled

A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors

Recruiting· Astellas logo

Astellas·Phase 1·NCT05719558·798 enrolled

A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Active, not recruiting· Regeneron logo

Regeneron·Preclinical·NCT04626635·548 enrolled

Metastatic Colorectal Cancer2 trials

Phase II Randomized Study Evaluating the Efficacy of Panitumumab (VEctibix ) and Trifluridine-Tipiracil (LOnsurf) in Pretreated RAS Wild Type Metastatic Colorectal Cancer Patients: the VELO Trial

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 2·NCT05468892·68 enrolled

5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer

Recruiting·TThe Methodist Hospital Research Institute·Phase 2·NCT06887218·57 enrolled

Intestinal Cancer1 trial

A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

Recruiting·OOncolytics Biotech·Phase 1/2·NCT07280377·122 enrolled

Esophageal Adenocarcinoma1 trial

A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06356311·450 enrolled

Colorectal Carcinoma1 trial

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer

Suspended·MM.D. Anderson Cancer Center·Phase 2·NCT07011550·7 enrolled

1 more indication

Advanced Microsatellite Stable Colorectal Cancer1 trial

A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Recruiting· Gilead logo

Gilead·Phase 2·NCT07527858·170 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Trifluridine-tipiracil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trifluridine-tipiracil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trifluridine-tipiracil. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Merck & Co.

Trifluridine-tipiracil

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2028

Q4 2029

Trials by Indication[1]

Solid Tumor3 trials

Metastatic Colorectal Cancer2 trials

Intestinal Cancer1 trial

Esophageal Adenocarcinoma1 trial

Colorectal Carcinoma1 trial

Advanced Microsatellite Stable Colorectal Cancer1 trial

References

Drug Info

Quick Facts

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