Last Updated: July 30, 2026

CLINICAL TRIALS PROFILE FOR FRUQUINTINIB


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505(b)(2) Clinical Trials for Fruquintinib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Novotech (Australia) Pty Limited PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Kahr Bio Australia Pty Ltd PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fruquintinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01645215 ↗ Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors Completed Fudan University Phase 1 2011-01-01 Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and multiple doses .
NCT01645215 ↗ Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors Completed Hutchison Medipharma Limited Phase 1 2011-01-01 Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and multiple doses .
NCT01955304 ↗ Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects Completed Hutchison Medipharma Limited Phase 1 2012-06-01 This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 4mg fruquintinib in normal healthy subjects.
NCT01975077 ↗ A Phase Ib Study of Fruquintinib in 3rd Line mCRC Completed Fudan University Phase 1/Phase 2 2012-12-01 Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these 2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and regimen in phase II/III study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fruquintinib

Condition Name

Condition Name for Fruquintinib
Intervention Trials
Colorectal Cancer 28
Metastatic Colorectal Cancer 25
Gastric Cancer 9
Fruquintinib 6
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Condition MeSH

Condition MeSH for Fruquintinib
Intervention Trials
Colorectal Neoplasms 75
Stomach Neoplasms 15
Adenocarcinoma 8
Rectal Neoplasms 7
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Clinical Trial Locations for Fruquintinib

Trials by Country

Trials by Country for Fruquintinib
Location Trials
China 164
United States 85
Japan 9
Australia 8
France 7
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Trials by US State

Trials by US State for Fruquintinib
Location Trials
Texas 9
Florida 6
California 6
Tennessee 5
Colorado 4
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Clinical Trial Progress for Fruquintinib

Clinical Trial Phase

Clinical Trial Phase for Fruquintinib
Clinical Trial Phase Trials
PHASE4 1
PHASE3 4
PHASE2 46
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Clinical Trial Status

Clinical Trial Status for Fruquintinib
Clinical Trial Phase Trials
Recruiting 60
Not yet recruiting 35
NOT_YET_RECRUITING 32
[disabled in preview] 13
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Clinical Trial Sponsors for Fruquintinib

Sponsor Name

Sponsor Name for Fruquintinib
Sponsor Trials
Hutchison Medipharma Limited 27
Fudan University 24
Sun Yat-sen University 9
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Sponsor Type

Sponsor Type for Fruquintinib
Sponsor Trials
Other 149
Industry 47
OTHER_GOV 6
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