Trifluridine and Tipiracil Hydrochloride

Phase 2Small molecule

Trifluridine and Tipiracil Hydrochloride is one of 65 small molecule programs targeting Gastroesophageal Junction Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction CancerRecruiting

Refractory Colorectal CarcinomaActive, not recruiting

Stage IV Colon CancerActive, not recruiting

Esophageal CancerRecruiting

GI CancersActive, not recruiting

Gastroesophageal Junction CancerPhase 2

Recruiting

Refractory Colorectal CarcinomaPhase 2

Active, not recruiting

Stage IV Colon CancerPhase 2

Active, not recruiting

Esophageal CancerPhase 1

Recruiting

GI CancersPhase 2

Active, not recruiting

Competition

Competitive Landscape

99 competitors in Esophageal Cancer

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

48 2

Eloxatin

Teva

Phase 3

32 3

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

58 4

Opdivo

Bristol-Myers Squibb

Phase 3

13 5

Paraplatin

AAvyxa

Phase 3

31 6

Keytruda

Merck & Co.

Phase 3

11 7

Taxotere

AAvyxa

Phase 3

21 8

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

19 9

Herceptin

Perjeta

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

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Esophageal Cancer

NCT04511039

Q3 2028

Phase 2Active, not recruiting

Refractory Colorectal Carcinoma

NCT03844620

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

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

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

Metastatic Colorectal Cancer2 trials

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

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

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

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

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

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

6 more indications

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

Rectal Cancer1 trial

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

GI Cancers1 trial

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

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

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

Refractory Colorectal Carcinoma1 trial

A Randomized Study Evaluating Tailoring of Advanced/Metastatic Colorectal Cancer (CRC) Therapy Using Circulating Cell-Free Tumor DNA (ctDNA) (TACT-D)

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

Rectal Adenocarcinoma1 trial

Phase 1b Study to Assess the Safety of Neoadjuvant TAS-102 (Trifluridine/Tipiracil) With Concurrent Radiation in Previously Untreated Resectable Stage II and Stage III Rectal Cancer (FIERCE)

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT04104139·19 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

Q2 2027

Q3 2028

Trials by Indication[1]

Colorectal Cancer3 trials

Metastatic Colorectal Cancer2 trials

Biliary Tract Cancer1 trial

Stage IV Colon Cancer1 trial

Adenocarcinoma1 trial

Esophageal Cancer1 trial

Rectal Cancer1 trial

GI Cancers1 trial

Gastroesophageal Junction Cancer1 trial

Refractory Colorectal Carcinoma1 trial

Rectal Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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