Trifluridine/Tipiracil

Phase 3Small molecule

AbbVie

Trifluridine/Tipiracil is one of 268 small molecule programs targeting Neutropenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

267

Competitors

Pipeline

Status by Indication[3][1]

Indication

NeutropeniaNot yet recruiting

Gastric AdenocarcinomaRecruiting

Metastatic Colorectal CancerCompleted

Breast CancerWithdrawn

Advanced Solid TumorsCompleted

TreatmentRecruiting

Locally-Advanced Rectal CancerRecruiting

BevacizumabRecruiting

MonotherapyRecruiting

NeutropeniaPhase 2

Not yet recruiting

Gastric AdenocarcinomaPhase 3

Recruiting

Metastatic Colorectal CancerPhase 3

Completed

Breast CancerPhase 2

Withdrawn

Advanced Solid TumorsPhase 2

Completed

TreatmentPhase 2

Recruiting

Locally-Advanced Rectal CancerPhase 2

Recruiting

BevacizumabPhase 2

Recruiting

MonotherapyPhase 2

Recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Trifluridine/Tipiracil

AbbVie

Phase 3

2 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Voltaren

Novartis

Preclinical

1 5

Zolymbus

AbbVie

Preclinical

1 6

Blenoxane

Bristol-Myers Squibb

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06242067

Phase 2Active, not recruiting

Gastric Adenocarcinoma

NCT05476796

Q3 2027

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT06614192

PreclinicalRecruiting

Colorectal Cancer

NCT05919264

Q4 2027

Phase 1Active, not recruiting

Advanced Solid Tumors

NCT05029882

Not yet recruiting

Real-World Study

NCT06195111

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer11 trials

A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)

Terminated·EElevar Therapeutics·Phase 1·NCT04073615·29 enrolled

Second-line Treatment of Metastatic Colorectal Cancer

Recruiting·QQilu Hospital of Shandong University·Phase 2·NCT06242067·50 enrolled

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 3·NCT04737187·492 enrolled

Show 8 more trials

A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer

Completed·OOncoMed Pharmaceuticals, Inc.·Phase 1·NCT03031691·7 enrolled

Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients.

Active, not recruiting·GGruppo Oncologico del Nord-Ovest·Phase 1/2·NCT04564898·48 enrolled

Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer

Terminated· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 3·NCT05223673·7 enrolled

Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer

Completed·HHunan Cancer Hospital··NCT05869097·90 enrolled

- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT06856837·140 enrolled

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 3·NCT07549412·1,020 enrolled

AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT06614192·74 enrolled

The Efficacy of Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer: Multi-center Prospective Study in Taiwan

Completed·CChang Gung Memorial Hospital·Preclinical·NCT06495463·97 enrolled

Colorectal Cancer3 trials

Study for Evaluation of Murlentamab (GM102) Anti-tumoral Activity in Colorectal Cancers

Completed·GGamaMabs Pharma·Phase 2·NCT03799731·65 enrolled

An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT07525206·990 enrolled

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Recruiting·PParabilis Medicines, Inc.·Preclinical·NCT05919264·619 enrolled

Gastric Adenocarcinoma3 trials

Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

Recruiting·FFederation Francophone de Cancerologie Digestive·Phase 3·NCT07270991·324 enrolled

Cardiovascular Events From Trifluridine/Tipiracil +/- Oxaliplatin in Colorectal/Oesogastric Adenocarcinoma Patients

Terminated·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT04894123·1 enrolled

Randomised Phase II Study Evaluating Trifluridine/Tipiracil Plus Oxaliplatin ± Nivolumab Versus FOLFOX ± Nivolumab in Patients With HER2 Negative Locally Advanced, Recurrent or Metastatic Gastric, Oesophageal or Oesogastric Junction Adenocarcinoma

Active, not recruiting·UUNICANCER·Phase 2·NCT05476796·118 enrolled

Bevacizumab3 trials

Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05077839·184 enrolled

Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of Refractory mCRC.

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06060704·33 enrolled

ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC

Recruiting·SSun Yat-sen University·Phase 1/2·NCT07012954·64 enrolled

Treatment2 trials

Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC

Recruiting·WWangxia LV·Phase 1/2·NCT06379399·26 enrolled

LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy

Active, not recruiting·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT04166604·176 enrolled

16 more indications

Advanced Solid Tumors2 trials

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT05029882·520 enrolled

A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Completed· UCB logo

UCB·Phase 1/2·NCT04393298·93 enrolled

Breast Cancer2 trials

A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer

Withdrawn·AAHS Cancer Control Alberta·Phase 2·NCT04149444

TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer

Active, not recruiting·BBorstkanker Onderzoek Groep·Phase 2·NCT04489173·52 enrolled

Cholangiocarcinoma1 trial

Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma

Terminated·SSunnybrook Health Sciences Centre·Phase 2·NCT04076761·8 enrolled

Monotherapy1 trial

Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC

Recruiting·FFudan University·Phase 2·NCT05970705·101 enrolled

Refractory1 trial

A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

Completed·HHellenic Study Group of Psychoneuroimmunology in Cancer··NCT04965870·200 enrolled

Neutropenia1 trial

BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients

Not yet recruiting·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT07071844·162 enrolled

Locally-advanced Rectal Cancer1 trial

Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy

Recruiting·SSun Yat-sen University·Phase 2·NCT05965531·65 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC

Recruiting·FFirst Affiliated Hospital of Wenzhou Medical University·Phase 2·NCT06485713·200 enrolled

PD-1 Inhibitors1 trial

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Completed·HHunan Cancer Hospital··NCT06031376·106 enrolled

Colon Cancer1 trial

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

Suspended·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT05062889·477 enrolled

Real-world Study1 trial

A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06195111·200 enrolled

Biliary Tract Cancer1 trial

A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy

Suspended·CCase Comprehensive Cancer Center·Phase 2·NCT07146646·27 enrolled

Resistance1 trial

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07318389·100 enrolled

Refractory Metastatic Colorectal Cancer1 trial

Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Trifluridine/Tipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer

Withdrawn·BBiotech Pharmaceutical Co., Ltd.·Phase 3·NCT06343116

Gastric Cancer1 trial

Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer / Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I / II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)

Recruiting·KKyushu University·Preclinical·NCT05438459·176 enrolled

Metastatic Colorectal Cancer (CRC)1 trial

ROMANCE GOIM Study: A Phase II, Open Label, Multicenter Trial Investigating Irinotecan Plus Cetuximab Rechallenge Compared With Trifluridine/Tipiracil Plus Bevacizumab as Third Line Treatment in Circulating Tumor DNA Molecularly Selected Metastatic Colorectal Cancer

Recruiting·GGruppo Oncologico Italia Meridionale·Phase 2·NCT07381764·150 enrolled

Sources

References

[1]
ClinicalTrials.gov — 40 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 — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AbbVie

Trifluridine/Tipiracil

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Metastatic Colorectal Cancer11 trials

Colorectal Cancer3 trials

Gastric Adenocarcinoma3 trials

Bevacizumab3 trials

Treatment2 trials

Advanced Solid Tumors2 trials

Breast Cancer2 trials

Cholangiocarcinoma1 trial

Monotherapy1 trial

Refractory1 trial

Neutropenia1 trial

Locally-advanced Rectal Cancer1 trial

Efficacy and Safety1 trial

PD-1 Inhibitors1 trial

Colon Cancer1 trial

Real-world Study1 trial

Biliary Tract Cancer1 trial

Resistance1 trial

Refractory Metastatic Colorectal Cancer1 trial

Gastric Cancer1 trial

Metastatic Colorectal Cancer (CRC)1 trial

References

Drug Info

Quick Facts

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