Trifluridine and Tipiracil Hydrochloride

Phase 2Small molecule

Trifluridine and Tipiracil Hydrochloride is one of 167 small molecule programs targeting Esophageal Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

166

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Biliary Tract CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Esophageal CancerPhase 1

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

Competition

Competitive Landscape

949 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Trifluridine and Tipiracil Hydrochloride

RRoswell Park Cancer Institute

Phase 2

3 2

Eylea

Regeneron

Preclinical

5 3

Emend IV

PORTRAZZA

Ketalar

AAultman Health Foundation

Preclinical

1 6

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 7

Versed

CConrado Roberto Hoffmann Filho

Preclinical

1 8

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Bridion

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 10

Feraheme

AAzurity Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT03844620

Q2 2027

Phase 1Recruiting

Esophageal Cancer

NCT04511039

Clinical

Trials by Indication[1]

Colorectal Cancer3 trials

Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer

Completed·—·Phase 2·NCT03981614·102 enrolled

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Active, not recruiting·—·Phase 2·NCT03992456·12 enrolled

TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study

Completed·RRoswell Park Cancer Institute·Phase 2·NCT04109924·42 enrolled

Metastatic Colorectal Cancer3 trials

Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study

Withdrawn·—·Phase 2·NCT05356897

Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03844620·100 enrolled

A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer

Completed·MMayo Clinic·Phase 1·NCT05130060·15 enrolled

Rectal Cancer2 trials

TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04104139·19 enrolled

Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

Completed·—·Phase 1·NCT03317119·26 enrolled

Biliary Tract Cancer1 trial

Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer

Completed·MMayo Clinic·Phase 2·NCT04072445·28 enrolled

Esophageal Cancer1 trial

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

Recruiting·RRoswell Park Cancer Institute·Phase 1·NCT04511039·45 enrolled

4 more indications

Gastroesophageal Junction Cancer1 trial

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

Recruiting·—·Phase 2·NCT04660760·116 enrolled

Stage IV Colon Cancer1 trial

TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer

Active, not recruiting·RRutgers, The State University of New Jersey·Phase 2·NCT04294264·50 enrolled

GI Cancers1 trial

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

Active, not recruiting·EEmory University·Phase 1/2·NCT03368963·64 enrolled

Adenocarcinoma1 trial

Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma

Completed·RRoswell Park Cancer Institute·Phase 2·NCT04097028·22 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Trifluridine and Tipiracil Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trifluridine and Tipiracil Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trifluridine and Tipiracil Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roswell Park Cancer Institute company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: RRoswell Park Cancer Institute

Trifluridine and Tipiracil Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q2 2027

Trials by Indication[1]

Colorectal Cancer3 trials

Metastatic Colorectal Cancer3 trials

Rectal Cancer2 trials

Biliary Tract Cancer1 trial

Esophageal Cancer1 trial

Gastroesophageal Junction Cancer1 trial

Stage IV Colon Cancer1 trial

GI Cancers1 trial

Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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