Trifluridine/Tipiracil

Phase 3Small molecule

AbbVie

Trifluridine/Tipiracil is one of 225 small molecule programs targeting Neutropenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

224

Competitors

Pipeline

Status by Indication[3][1]

Indication

NeutropeniaActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Biliary Tract CancerActive, not recruiting

Breast CancerActive, not recruiting

Colorectal CancerRecruiting

CholangiocarcinomaActive, not recruiting

NeutropeniaPhase 2

Active, not recruiting

Gastric AdenocarcinomaPhase 3

Active, not recruiting

Metastatic Colorectal CancerPhase 3

Active, not recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Colorectal CancerPhase 3

Recruiting

CholangiocarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Trifluridine/Tipiracil

AbbVie

Phase 3

2 2

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 3

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 4

Cortef

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

Preclinical

1 5

Acupan

YYonsei University

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Aquasol E

NNational Eye Institute (NEI)

Paracetamol

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06242067

Q1 2027

Phase 2Recruiting

Gastroesophageal Junction Cancer

NCT05476796

Q2 2027

Phase 2Recruiting

Biliary Tract Cancer

NCT07146646

Phase 3Not yet recruiting

Metastatic Colorectal Cancer

NCT06343116

Q3 2027

Phase 1/2Recruiting

Locally Advanced or Metastatic Solid Tumors

NCT05919264

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer13 trials

A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06614192·460 enrolled

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

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

Second-line Treatment of Metastatic Colorectal Cancer

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

Show 10 more trials

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

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

- 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

ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"

Not yet recruiting·GGruppo Oncologico Italia Meridionale·Phase 2·NCT07381764·150 enrolled

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

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

Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan

Recruiting·—·N/A·NCT06495463·110 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

Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

Not yet recruiting·BBiotech Pharmaceutical Co., Ltd.·Phase 3·NCT06343116·420 enrolled

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

Completed·HHunan Cancer Hospital··NCT05869097·90 enrolled

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07318389·100 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

Advanced Solid Tumors2 trials

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

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

Gastric Adenocarcinoma2 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

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

14 more indications

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

Colorectal Cancer2 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·NCT07525206·700 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

Locally Advanced or Metastatic Solid Tumors1 trial

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Recruiting·PParabilis Medicines, Inc.·Phase 1/2·NCT05919264·575 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

Gastroesophageal Junction Cancer1 trial

Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer

Recruiting·UUNICANCER·Phase 2·NCT05476796·118 enrolled

Biliary Tract Cancer1 trial

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Recruiting·—·Phase 2·NCT07146646·27 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

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

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

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

Sources

References

[1]
ClinicalTrials.gov — 38 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

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Metastatic Colorectal Cancer13 trials

Bevacizumab3 trials

Advanced Solid Tumors2 trials

Gastric Adenocarcinoma2 trials

Treatment2 trials

Breast Cancer2 trials

Colorectal Cancer2 trials

Real-world Study1 trial

Locally Advanced or Metastatic Solid Tumors1 trial

Neutropenia1 trial

Gastroesophageal Junction Cancer1 trial

Biliary Tract Cancer1 trial

Locally-advanced Rectal Cancer1 trial

Efficacy and Safety1 trial

Colon Cancer1 trial

PD-1 Inhibitors1 trial

Cholangiocarcinoma1 trial

Monotherapy1 trial

Refractory1 trial

References

Drug Info

Quick Facts

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