Data updated: May 26, 2026
FRUZAQLA (fruquintinib)
Genetically Validated
Trial Activity: Growth 39 active trials
Priority Review Fast Track
Oncology
Approved 2023-11-08
FRUZAQLA is indicated for the treatment of Colorectal Cancer.
Source: FDA Label • Takeda
How FRUZAQLA Works
Fruquintinib is a small molecule kinase inhibitor that selectively targets vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. By inhibiting these receptors, the drug blocks VEGF-mediated endothelial cell proliferation, tubular formation, and VEGFR-2 phosphorylation. This action suppresses tumor angiogenesis and inhibits overall tumor growth.
Development Insights
Hutchison Medipharma Limited conducting 12 trials (21%)
51 indications explored (Broad Platform)
→ colorectal cancer (16 trials)
→ metastatic colorectal cancer (5 trials)
→ colon cancer (3 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-11-08
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FRUZAQLA Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2023 to 2025
What FRUZAQLA Treats
1 indicationsFRUZAQLA is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Colorectal Cancer
Source: FDA Label
FRUZAQLA Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
VEGF (Vascular Endothelial Growth Factor) ligand
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
FRUZAQLA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
9
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 15 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in FRUZAQLA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FRUZAQLA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FRUZAQLA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
58 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04164199 | BGB-A317-290-LTE1 2019-002554-23, 2023-508883-31-00 | Ph 3 | active not recruiting | Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies |
| NCT07235293 | DSP107_003 | Ph 2 | recruiting | A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. |
| NCT07510932 FIRST-K | K2025-2257-007 | Ph 2 | not yet recruiting | Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K) |
| NCT07136077 | 2025-0696 NCI-2025-06047 | Ph 2 | recruiting | A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy |
| NCT07502014 | TJ-IRB202512151 | Ph 2 | not yet recruiting | A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer |
| NCT06497985 | CDM303 | Ph 3 | recruiting | A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients |
| NCT07011576 FRUITFUL | GI 387 | Ph 2 | recruiting | A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC) |
| NCT06992258 FRUITION | CCR-AGICC-Fruq-004 | Ph 2 | recruiting | A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer |
| NCT07446465 | FRUTISCO | Ph 4 | not yet recruiting | FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer |
| NCT06562543 | TAK-113-4002 | Ph 4 | recruiting | A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer |
| NCT07392346 | 2026-003 | Ph 2 | recruiting | Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer |
| NCT07270991 FRUQUITAS | ENGIC06-PRODIGE114-FRUQUITAS 2025-522395-92-00 | Ph 3 | recruiting | Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma |
| NCT05867420 | ASKG915-101 | Ph 1, Ph 2 | recruiting | A Study of ASKG915 in Patients With Selected Advanced Solid Tumors. |
| NCT05954429 | FDCRC87PJJ | Ph 2 | recruiting | A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study |
| NCT06856837 | QUINTIS | Ph 2 | recruiting | - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases |
| NCT07229872 | QL-CRC-QIBA-3007 | Ph 2 | not yet recruiting | A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment |
| NCT07130903 | 2025-035 | Ph 2 | recruiting | Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer |
| NCT07170982 | HMPL-013-FLAG-E001 | Ph 2 | not yet recruiting | Fruquintinib Combined With Standard Chemotherapy Versus Standard Chemotherapy as First-line Treatment for Advanced pMMR Endometrial Cancer |
| NCT07150403 | PRODIGE 115 - FFCD 2406-ULYSSE 2025-522108-26-00 | Ph 2 | not yet recruiting | Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer |
| NCT06441565 | FAITH-CRC | Ph 2, Ph 3 | recruiting | Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer |
| NCT04577963 results posted | 2020-013-00US3 | Ph 1, Ph 2 | terminated | A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors |
| NCT05771181 | VENTIF | Ph 2 | recruiting | Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients |
| NCT05941325 | 2023-025 | Ph 2 | suspended | A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma |
| NCT05848739 | ST316-101 | Ph 1 | recruiting | A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors |
| NCT04322539 FRESCO-2 results posted | 2019-013-GLOB1 | Ph 3 | completed | A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer |
| NCT04716634 results posted | BGB-A317-fruquintinib-201 CTR20211070 | Ph 2 | completed | Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors |
| NCT06791083 | HMPL-013-E1-GC003 | Ph 2 | recruiting | Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer |
| NCT06427005 | 2023-71 | Ph 2 | recruiting | Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC |
| NCT06774222 | 2022-421 | Ph 2 | recruiting | A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG |
| NCT06584032 | 2024-013-00CH1 | Ph 3 | recruiting | Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer |
| NCT05522231 | 2022-013-00CH1 | Ph 2, Ph 3 | active not recruiting | Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2) |
| NCT06446154 | FRU-001 | Ph 2 | recruiting | Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma |
| NCT06685276 | 2024-415 | Ph 2 | recruiting | Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer |
| NCT06646588 SJZ-RMEEC01 | SJZ-RMEEC01 | Ph 2 | recruiting | Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Esophageal Squamous Cell Carcinoma |
| NCT06543836 | NCC4663 | Ph 2 | recruiting | ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer |
| NCT06484153 | union-P | Ph 1, Ph 2 | not yet recruiting | Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma |
| NCT06218888 | TFC | Ph 2 | not yet recruiting | A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases |
| NCT06168786 | CRC-II-001 | Ph 2 | recruiting | Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC |
| NCT06118762 | HMPL-013-E1-C002 | Ph 4 | recruiting | Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer |
| NCT06094868 | HMPL-013-E1-GC002 | Ph 2 | not yet recruiting | Clinical Study of Fruquintinib Combined With Sintilimab and XELOX Regimen in the Treatment of Advanced Cancer |
| NCT06018714 | 2023-FXY-096-Department of CRC | Ph 2 | recruiting | Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study |
| NCT05914610 | FUGES-028 | Ph 3 | not yet recruiting | Envollizumab Combined With Fruquintinib and SOX Versus SOX for Conversion Therapy in Advanced Gastric Cancer |
| NCT05216354 | 2021-013-00US2 | Ph 1 | completed | Fruquintinib Renal Impairment Study |
| NCT05025631 DOFEMCRC | HMPL-013-FLAG-C110 | Ph 2 | completed | A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC） |
| NCT05216367 | 2021-013-00US1 | Ph 1 | completed | Fruquintinib Hepatic Impairment Study |
| NCT05368805 | 2021-013-00US3 | Ph 1 | completed | Fruquintinib DDI Study With P-gp and BCRP Substrates |
| NCT04557397 | 2020-013-00US2 | Ph 1 | completed | Fruquintinib CYP3A Inhibitor and Inducer Study |
| NCT02196688 results posted | 2012-013-00CH1 | Ph 2 | completed | Study of Fruquintinib in Patients With Metastatic Colorectal Cancer |
| NCT01645215 | 2009-013-00CH1 | Ph 1 | completed | Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors |
| NCT01955304 | 2012-013-00CH2 | Ph 1 | completed | Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects |
Showing 50 of 58 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FRUZAQLA FDA Label Details
Indications & Usage
FDA Label (PDF)FRUZAQLA is indicated for the treatment of Colorectal Cancer.
View full patent landscape →
4 OB patents · 2 families ·
107 international docs across 38 countries
FRUZAQLA Patents & Exclusivity
Latest Patent: Sep 2035
Exclusivity: Nov 2028
Patents (4 active)
US11046674
Expires Sep 7, 2035
US10519142
Expires Sep 7, 2035
US7829574
Expires Mar 23, 2032
US8212033
Expires May 9, 2028
Exclusivity
NCE
Until Nov 2028
NCE
Until Nov 2028
NCE
Until Nov 2028
NCE
Until Nov 2028
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for FRUZAQLA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 16 active patents
Trial Analysis
- • 57 total trials
- • Stage: Growth
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment