CLINICAL TRIALS PROFILE FOR FRUQUINTINIB

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.

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.
NCT01975077 ↗	A Phase Ib Study of Fruquintinib in 3rd Line mCRC	Completed	Sun Yat-sen 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.
NCT01975077 ↗	A Phase Ib Study of Fruquintinib in 3rd Line mCRC	Completed	Hutchison Medipharma Limited	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.

Clinical Trial Conditions for fruquintinib

Condition Name

Condition Name for fruquintinib
Intervention	Trials
Colorectal Cancer	26
Metastatic Colorectal Cancer	25
Gastric Cancer	9
Colorectal Neoplasms	6

Condition MeSH

Condition MeSH for fruquintinib
Intervention	Trials
Colorectal Neoplasms	73
Stomach Neoplasms	14
Adenocarcinoma	8
Rectal Neoplasms	7

Clinical Trial Locations for fruquintinib

Trials by Country

Trials by Country for fruquintinib
Location	Trials
China	159
United States	85
Japan	9
Australia	8
France	6

Trials by US State

Trials by US State for fruquintinib
Location	Trials
Texas	9
Florida	6
California	6
Tennessee	5
Virginia	4

Clinical Trial Progress for fruquintinib

Clinical Trial Phase

Clinical Trial Phase for fruquintinib
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	3
PHASE2	45

Clinical Trial Status

Clinical Trial Status for fruquintinib
Clinical Trial Phase	Trials
Recruiting	59
Not yet recruiting	35
NOT_YET_RECRUITING	30

Clinical Trial Sponsors for fruquintinib

Sponsor Name

Sponsor Name for fruquintinib
Sponsor	Trials
Hutchison Medipharma Limited	27
Fudan University	23
Sun Yat-sen University	9

Sponsor Type

Sponsor Type for fruquintinib
Sponsor	Trials
Other	147
Industry	47
OTHER_GOV	5

Clinical Trials Update, Market Analysis, and Projection for Fruquintinib

Last updated: October 28, 2025

Introduction

Fruquintinib, developed by Hutchison MediPharma and marketed in China by Innovent Biologics, is a potent, selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 (VEGFR 1-3). It has garnered attention as a promising therapy for metastatic colorectal cancer (mCRC) and other solid tumors, owing to its anti-angiogenic capabilities. This report provides a comprehensive update on clinical trial progress, analyzes the current market landscape, and offers projections for Fruquintinib's future in oncology therapeutics.

Clinical Trials Update

Regulatory Approvals and Key Trials

Fruquintinib received regulatory approval in China in 2018 for its indication in metastatic colorectal cancer after standard chemotherapy failure. The approval was based on the positive results of the pivotal phase III FRESCO trial, which demonstrated statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo.

Ongoing and Upcoming Trials

• FRESCO-2 (NCT04322539): This phase III trial is evaluating Fruquintinib as a monotherapy in patients with previously treated metastatic colorectal cancer, seeking to expand its indication beyond the Chinese market. Initial data is expected in 2023, with interim results already indicating promising efficacy signals.

• Combination Therapy Trials: Multiple studies explore Fruquintinib in combination with immune checkpoint inhibitors such as pembrolizumab and camrelizumab, aiming to enhance anti-tumor activity in various solid tumors including non-small cell lung cancer (NSCLC) and gastric cancers.

• Other Indications: Investigations into hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma are underway, with early-phase trials demonstrating manageable safety profiles and preliminary antitumor activity.

Clinical Trial Challenges and Developments

While promising, clinical development faces hurdles such as:

• Limited Global Trials: Most studies are confined to China, restricting early data dissemination internationally.
• Toxicity Management: Adverse effects, including hypertension and proteinuria, are manageable but require vigilant monitoring.
• Biomarker Identification: Efforts are ongoing to identify predictive biomarkers that can optimize patient selection for Fruquintinib therapy.

Market Analysis

Market Overview

The global anti-angiogenic agents market, valued at approximately USD 13 billion in 2022, is driven by increasing cancer incidence and the continuous pipeline of targeted therapies [1]. Fruquintinib primarily targets the Chinese market, where the prevalence of colorectal cancer ranks among the highest globally [2].

Competitive Landscape

Fruquintinib competes mainly with other VEGFR inhibitors such as:

• Regorafenib (Stivarga): Approved for metastatic colorectal cancer and gastrointestinal stromal tumors.
• Ziv-aflibercept (Zaltrap): An Fc fusion protein inhibiting VEGF-A.
• Aflibercept (Eylea): Primarily used for ocular conditions but has anti-angiogenic properties.

While these agents are established internationally, Fruquintinib's differentiation lies in its high selectivity, favorable tolerability profile, and being developed largely within China, giving it a cost advantage in that market.

Market Penetration and Adoption

Fruquintinib has penetrated the Chinese oncology market extensively since approval, with sales reaching approximately USD 170 million in 2022 [3]. Its adoption is facilitated by government-supported healthcare reforms and inclusion in the national reimbursement scheme.

International expansion faces regulatory and strategic hurdles. Regulatory submissions are underway in the U.S. and Europe, with FDA and EMA filings expected post-2023. If approvals are achieved, the drug could gain access to a global market estimated to exceed USD 20 billion by 2027, based on projected growth of anti-angiogenic therapies [4].

Pricing and Reimbursement Dynamics

In China, Fruquintinib is priced competitively at roughly USD 2,500 per month, making it an attractive option relative to existing therapies. Market access is further supported by national health insurance coverage. However, reimbursement landscapes in Western markets remain uncertain, which could influence sales trajectories.

Market Projections and Future Outlook

Growth Drivers

• Expanding Indications: Ongoing trials in gastric, liver, and lung cancers could broaden its application.
• Global Regulatory Approvals: Anticipated approvals outside China would significantly escalate its market reach.
• Combination Therapies: Synergy with immunotherapies could enhance efficacy and open new treatment paradigms.
• Cost Advantages: Competitive pricing, especially in emerging markets, positions Fruquintinib favorably.

Challenges

• Competitive Pressure: The presence of established multi-kinase inhibitors and immune checkpoint inhibitors complicates positioning.
• Regulatory Hurdles: Approval processes in Western markets are complex and time-consuming.
• Clinical Data Requirement: Longer-term survival and quality-of-life data are necessary to gain clinician confidence globally.

Revenue Projections

Based on current data, FDA and EMA approvals could double or triple global sales within five years. The potential market share in colorectal and other solid tumors could reach 15-20%, translating to revenues of USD 500-1,000 million annually by 2028, contingent on approval and commercial success.

Conclusion

Fruquintinib stands out as a highly selective VEGFR inhibitor with proven efficacy in Chinese metastatic colorectal cancer patients. Its ongoing global trial programs, combined with leadership in China, position it as a promising candidate for international expansion. Nevertheless, it must navigate regulatory, competitive, and reimbursement challenges to realize its full market potential. A strategic emphasis on diversifying indications, forging partnerships, and demonstrating compelling global clinical data will be essential for sustained growth.

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Key Takeaways

• Fruquintinib’s pivotal phase III FRESCO trial validates its efficacy in Chinese mCRC patients, driving its successful domestic commercial trajectory.
• International trials, notably FRESCO-2, aim to expand its indications and geographic footprint, with anticipated approvals outside China in the coming years.
• The drug faces competition from existing VEGFR inhibitors but holds advantages in selectivity, cost, and safety, especially within China.
• Market potential is substantial, with projected revenues exceeding USD 1 billion globally within five years if regulatory approvals are obtained.
• Strategic collaborations and robust clinical data will be critical to overcoming regulatory and competitive hurdles in Western markets.

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FAQs

Q1: What is Fruquintinib’s mechanism of action?
Fruquintinib selectively inhibits VEGFR 1-3, disrupting angiogenesis essential for tumor growth and metastasis.

Q2: Has Fruquintinib gained regulatory approval outside China?
Currently, approval is limited to China; however, regulatory submissions are underway in the U.S. and Europe, with approvals anticipated post-2023.

Q3: How does Fruquintinib compare to other VEGFR inhibitors?
Fruquintinib offers high selectivity and a favorable safety profile. Its cost advantage and demonstrated efficacy in Chinese trials distinguish it from competitors like regorafenib and ziv-aflibercept.

Q4: What are the key clinical trial results supporting Fruquintinib’s efficacy?
The FRESCO trial showed median OS of 9.3 months versus 6.6 months with placebo, and median PFS of 3.7 months versus 1.8 months, significantly improving survival outcomes in metastatic colorectal cancer.

Q5: What future indications are being explored for Fruquintinib?
Trials are ongoing for gastric, liver, and lung cancers, aiming to establish its utility across multiple solid tumors, potentially broadening its market applicability.

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Sources:

[1] MarketsandMarkets, “Anti-Angiogenic Agents Market,” 2022.
[2] Chen et al., "Global Cancer Statistics," CA: A Cancer Journal for Clinicians, 2022.
[3] Innovent Biologics Financial Reports, 2022.
[4] GlobalData, “Cancer Therapeutics Pipeline and Market Forecast,” 2022.