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Drug

Fruquintinib

Approved · EMA
Emerging researchLate-stage development

Also known as Fruzaqla.

RxNorm2670179ChEMBLCHEMBL4303214UNII49DXG3M5ZW
1
Research papers
43
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized Phase 1b/2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Clinical trial2026-07-22Primary completion · ClinicalTrials.gov

A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

Clinical trial2026-07-07Results expected Q4 2027 · ClinicalTrials.gov

A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

Clinical trial2026-06-12Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable Colorectal Cancer

Clinical trial2026-06-08Results expected Q3 2026 · ClinicalTrials.gov

A Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer

Clinical trial2026-06-02Results expected Q4 2027 · ClinicalTrials.gov

A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

Clinical trial2026-06-01Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

Clinical trial2026-05-26Results expected Q1 2031 · ClinicalTrials.gov

An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies

Clinical trial2026-05-23Completed · ClinicalTrials.gov

A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer

Clinical trial2026-05-18Results expected Q3 2027 · ClinicalTrials.gov

Approval: Fruzaqla (EMA)

Regulatory2024-06-20EMA

Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study.

Research2017-01-19Journal of hematology & oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fruquintinib
Aliases & brands
Fruzaqla
RxNorm CUI
2670179
ChEMBL ID
CHEMBL4303214
UNII
49DXG3M5ZW
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-06-20
Latest approval
2024-06-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-06-20Approval
Approval: Fruzaqla (EMA)
Indication: Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard… Show full indication

Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF agents, and anti EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine tipiracil or regorafenib.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

86 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
86
registered trials across all phases
LATEST COMPLETION 2026
43
Active studies
41
Recruiting
16
Late-stage (III+)
18
Completed
25
Discontinued
PHASE DISTRIBUTIONn = 86
Early Phase 11Phase 111Phase 1 / 27Phase 251Phase 2 / 32Phase 38Phase 43Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

RecruitingPH IVTakedan=782027

Exploratory Clinical Study of FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

Not yet recruitingPH IVYe Xun=422027

A Single-arm, Open, Multicenter Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

RecruitingPH IVThe First Affiliated Hospital of Nanchang Universityn=302026

Randomized Phase III Trial to Compare Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

RecruitingPH IIIFederation Francophone de Cancerologie Digestiven=3242030

Fruquintinib Plus Arterial Infusion Therapy With Hepatic FOLFOX for Refractory Colorectal Cancer: The FAITH Randomized Clinical Trial

RecruitingPH II/IIISun Yat-sen Universityn=842029

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies

CompletedPH IIIBeOne Medicinesn=4042026

A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

CompletedPH IIIHutchison Medipharma Limitedn=6912024

A Multicenter, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Patients With Selected Solid Tumors

CompletedPH IIBeiGenen=842024

An Open-Label, Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of Fruquintinib

CompletedPH IHutchmedn=242023

A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients With Advanced Solid Tumors

CompletedPH IHutchison Medipharma Limitedn=1292023

A Phase II Study on Dose Optimization of Fruquintinib in Elderly Metastatic Colorectal Cancer Patients Refractory to Standard Treatment

CompletedPH IIZhen-Yu Dingn=292022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Journal of hematology & oncology1
Leading researchers
  • Bai Y1
  • Cao J1
  • Fan S1
  • Hua Y1
  • Li J1
  • Liu T1
  • Pan H1
  • Shen L1
Leading institutions
free-text, unnormalised
  • 307th Hospital of PLA1
  • Beijing Cancer Hospital1
  • Fudan University Shanghai Cancer Center1
  • Fudan University Zhongshan Hospital1
  • Harbin Medical University Cancer Hospital1
  • Shanghai First People's Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.