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.
NCT02196688 ↗	Study of Fruquintinib in Patients With Metastatic Colorectal Cancer	Completed	Fudan University	Phase 2	2014-04-01	Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

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

Condition MeSH

Condition MeSH for fruquintinib
Intervention	Trials
Colorectal Neoplasms	75
Stomach Neoplasms	15
Adenocarcinoma	8
Rectal Neoplasms	7

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

Trials by US State

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

Clinical Trial Progress for fruquintinib

Clinical Trial Phase

Clinical Trial Phase for fruquintinib
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	4
PHASE2	46

Clinical Trial Status

Clinical Trial Status for fruquintinib
Clinical Trial Phase	Trials
Recruiting	60
Not yet recruiting	35
NOT_YET_RECRUITING	32

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

Sponsor Type

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

Fruquintinib: Clinical Trials Update and Market Analysis With Forecast

Last updated: April 27, 2026

What is fruquintinib and what is it used for?

Fruquintinib is an oral, selective inhibitor of VEGFR1-3 developed for advanced solid tumors. The key late-stage development program is in colorectal cancer, including refractory disease after standard therapies.

What is the current regulatory status and label scope?

Fruquintinib has regulatory approvals in multiple jurisdictions for previously treated metastatic colorectal cancer (mCRC) after progression on chemotherapy, including as part of later-line therapy paradigms that follow or include anti-EGFR or anti-VEGF strategies depending on prior exposure.

Regulatory position (high-level):

• Indication focus: advanced or metastatic colorectal cancer after failure of standard treatments.
• Line of therapy: later-line, typically after standard chemotherapies and, where applicable, targeted agents.

Clinical trials update: where fruquintinib stands

Below is a structured view of the most decision-relevant clinical activity categories for fruquintinib: late-stage colorectal cancer programs, combination strategies, and ongoing studies that can expand label breadth or reposition lines of therapy.

Which trials drive the near-term label and evidence base?

Fruquintinib’s clinical trajectory is anchored by colorectal cancer trials that evaluated:

• Single-agent efficacy in refractory mCRC
• Combination regimens with cytotoxic chemotherapy and/or other targeted agents to improve response rates and survival endpoints

Key late-stage trial identifiers commonly cited in public records and publications include programs by the product developer and major trial registries for:

• Refractory mCRC (primary)
• Combination development (secondary expansion)

What endpoints and trial design elements matter for market outcomes?

Market adoption for later-line oncology agents is driven by:

• Overall survival (OS) benefit in heavily pretreated settings
• Progression-free survival (PFS) improvements that support guideline inclusion
• Objective response rate (ORR) and duration of response (DOR) where relevant
• Tolerability in combination settings (dose intensity, discontinuation rates)
• Subgroup consistency (including prior anti-VEGF exposure and molecular status where assessed)

How do trial readouts typically translate to payer and guideline uptake?

In late-line metastatic colorectal cancer:

• OS improvements often determine formulary status
• PFS advantages support sequencing into earlier lines when supported by combination evidence
• Safety profiles affect combination viability with chemotherapy schedules

What is the most recent clinical evidence signal?

Public sources continue to support fruquintinib as an effective later-line option in mCRC, with ongoing and planned studies exploring combinations to extend clinical utility beyond single-agent later-line use. Published reports and registry-linked datasets consistently cite meaningful survival benefit signals versus control comparators in refractory populations (see sources [1]-[4]).

How does combination development impact future market size?

The biggest swing factor for a growth forecast is label expansion through combinations. Fruquintinib combinations can:

• Shift usage from “salvage after exhaustion” toward earlier lines
• Expand eligible patient pools if efficacy is demonstrated across broader subgroups
• Increase treatment duration and adherence if tolerability supports longer exposure

Combination programs in oncology frequently aim to lift:

• PFS and ORR (more rapid disease control)
• OS in settings with stronger mechanistic rationale
• Clinical durability to maintain therapy beyond first response

Market analysis: current size drivers

Who are the addressable patients?

For fruquintinib, the immediate addressable market is driven by:

• Metastatic colorectal cancer incidence and progression
• Proportion who reach later-line therapy after standard chemotherapy
• Access and sequencing patterns that determine whether VEGFR inhibition is used before or after other targeted options

The commercial funnel in later-line mCRC:

1. Diagnosed mCRC patients
2. Treated with standard systemic regimens
3. Progress to refractory settings
4. Seek later-line targeted therapy options

What competitors shape adoption and pricing power?

Competition in late-line mCRC is characterized by:

• Anti-angiogenic agents (VEGF pathway inhibitors)
• Other later-line targeted options depending on molecular status
• Immunotherapy in MSI-H/dMMR subsets (where eligible) which can redirect the competitive landscape away from VEGFR inhibitors

In practice, fruquintinib competes for later-line patients who are not eligible for (or have progressed after) immunotherapy or molecularly targeted approaches.

What payer and formulary behavior determines revenue ramp?

Later-line oncology drugs are typically:

• Covered after failure of prior regimens
• Required to demonstrate survival benefit and manageable toxicity
• Subject to line-of-therapy restrictions and step edits

The speed of adoption depends on:

• Inclusion in treatment guidelines
• Hospital uptake through oncology formularies
• Availability of companion testing if required by label

Market projection: revenue and volume outlook

Because fruquintinib’s commercial model depends on jurisdiction-specific approvals, uptake rates, and the degree of sequencing shift through combinations, forecasts must be built from scenario logic tied to uptake.

Base-case forecast structure

A workable projection model uses:

• Sales drivers: treated patient count × dosing duration × net price (after rebates)
• Adoption curve: time-to-formulary + line-of-therapy expansion
• Conversion events: new approvals and combination evidence readouts that change sequencing

Scenario framework for 2025-2030

1) Base case (label holds, moderate uptake):

• Fruquintinib remains a later-line option in mCRC
• Uptake grows with guideline inclusion and expanding access
• Limited sequencing shift beyond the current approved population

2) Upside case (combinations gain traction):

• Positive combination trial readouts produce expanded label or strong off-label adoption
• Greater patient pool reach due to earlier-line positioning
• Higher treatment duration increases prescription counts and persistence

3) Downside case (competition compresses price and line access):

• Competing VEGFR or alternative pathways gain preference
• Restrictive payers limit use to narrower lines
• Combination tolerability issues limit regimen uptake

Key volume math (how forecasts are built)

Market revenue is driven by:

• Prescribed cycles per patient
• Adherence and dose intensity
• Discontinuation rates (toxicity-driven discontinuation reduces realized dosing days)
• Patient eligibility after prior therapies

Fruquintinib’s forecast therefore hinges on tolerability in real-world oncology practice and on whether combination regimens maintain adequate dose intensity.

What factors most strongly determine fruquintinib’s mid-term upside?

Clinical evidence that moves the line of therapy

• OS and PFS benefit strength in refractory mCRC
• Magnitude of effect relative to active comparators used in contemporary practice
• Safety profile that supports sustained exposure

Operational factors

• Time to adoption via oncology centers
• Real-world persistence and the frequency of dose reductions
• Drug supply continuity and patient support programs

Key Takeaways

• Fruquintinib is positioned as a later-line VEGFR-targeting therapy in metastatic colorectal cancer, with clinical evidence and ongoing programs supporting continued adoption and potential label or sequencing expansion.
• The next revenue step-change depends on combination success that moves usage earlier in treatment pathways and broadens eligible patient populations.
• Market size will be set by later-line mCRC patient funnel size and constrained or expanded by payer line edits, competitive VEGFR and alternative options, and realized dosing intensity and persistence.

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FAQs

1) What cancer type and patient setting is fruquintinib primarily targeting?
Advanced or metastatic colorectal cancer in later-line settings after prior therapies.

2) What clinical endpoints drive the commercial narrative for fruquintinib in later-line mCRC?
Overall survival and progression-free survival are the dominant decision endpoints; safety and tolerability determine combination feasibility.

3) How do combination trials affect the forecast for fruquintinib?
They can expand the treated patient population by shifting use to earlier lines and increasing treatment duration if tolerability supports sustained dosing.

4) What payer behavior most directly impacts fruquintinib revenue?
Line-of-therapy restrictions and step edits after specific prior regimens shape whether the drug is used in the intended sequencing window.

5) What is the key downside risk for fruquintinib market growth?
Competition and restrictive coverage that limit access to later-line patients or reduce price and persistence through toxicity-related discontinuations.

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References

[1] ClinicalTrials.gov. Search results and trial records for fruquintinib in colorectal cancer and related indications. https://clinicaltrials.gov/
[2] PubMed. Publications and study reports on fruquintinib efficacy and safety in metastatic colorectal cancer. https://pubmed.ncbi.nlm.nih.gov/
[3] European Medicines Agency (EMA). Public assessment documents and product information related to VEGFR inhibitors and colorectal cancer oncology pathways (including fruquintinib where available). https://www.ema.europa.eu/
[4] U.S. Food and Drug Administration (FDA). Oncology product and labeling records relevant to fruquintinib and VEGFR inhibitor class use (where available). https://www.fda.gov/