Elunate

(Fruquintinib)

ApprovedSmall molecule

Fruquintinib is used to treat advanced colorectal cancer that has spread to other parts of the body and hasn't responded well to other treatments. It works by blocking proteins that help cancer cells grow and form new blood vessels.[2] Elunate is currently approved and in use across 28 indications[4].[1]

Elunate is one of 588 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

587

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Gastroesophageal Junction AdenocarcinomaApproved

Esophageal Squamous Cell CarcinomaRecruiting

Nonpapillary Renal Cell CarcinomaActive, not recruiting

Lung CancerApproved

Gastric AdenocarcinomaRecruiting

Kidney DiseaseApproved

Colorectal NeoplasmActive, not recruiting

Malignant Colon NeoplasmApproved

Stomach NeoplasmApproved

Metastatic Colorectal CancerRecruiting

Gastroesophageal Junction AdenocarcinomaApproved

Approved

Esophageal Squamous Cell CarcinomaPhase 2

Recruiting

Nonpapillary Renal Cell CarcinomaPreclinical

Active, not recruiting

Lung CancerApproved

Approved

Gastric AdenocarcinomaPhase 3

Recruiting

Kidney DiseaseApproved

Approved

Colorectal NeoplasmApproved

Active, not recruiting

Malignant Colon NeoplasmApproved

Approved

Stomach NeoplasmApproved

Approved

Metastatic Colorectal CancerApproved

Recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Elunate

Takeda

Approved

17 2

Camptosar

Pfizer

Phase 3

34 3

Keytruda

Merck & Co.

Phase 3

25 4

Fudr

Pfizer

Phase 3

17 5

Beyfortus

BeiGene

Phase 3

17 6

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

4 7

Systemic Chemotherapy

SSun Yat-sen University

Phase 3

5 8

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Phase 3

4 9

Cytokine-Induced Killer Cells

TThe First People's Hospital of Changzhou

Phase 3

2 10

Mfolfoxiri Plus Bevacizumab

FFudan University

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Colorectal Cancer

NCT06218888

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06685276

Phase 2Recruiting

Soft Tissue Sarcoma

NCT05941325

Phase 2Recruiting

To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma

NCT06484153

Phase 2Recruiting

Gastric Cancer

NCT06774222

Q1 2027

Post-ApprovalNot yet recruiting

Colorectal Cancer

NCT07446465

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer21 trials

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

Recruiting·SSCRI Development Innovations, LLC·Phase 2·NCT07011576·60 enrolled

Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

Not yet recruiting·FFederation Francophone de Cancerologie Digestive·Phase 2·NCT07150403·74 enrolled

Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 1·NCT06347198·30 enrolled

Show 18 more trials

The Combination of Fruquintinib, Tislelizumab and Stereotactic Ablative Radiotherapy in Metastatic Colorectal Cancer(RIFLE)

Unknown status·FFudan University·Phase 2·NCT04948034·68 enrolled

Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.

Recruiting·NNingbo Medical Center Lihuili Hospital·N/A·NCT06613113·30 enrolled

Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

Recruiting·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT07130903·102 enrolled

Geptanolimab(GB226) Combined With Fruquintinib in the Treatment of Metastatic Colorectal Cancer

Unknown status·GGenor Biopharma Co., Ltd.·Phase 1·NCT03977090·21 enrolled

Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

Not yet recruiting·FFederation Francophone de Cancerologie Digestive·N/A·NCT07124858·300 enrolled

Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study

Completed·FFudan University··NCT06202417·520 enrolled

The Efficacy and Safety of Fruquintinib Plus FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer

Unknown status·FFudan University·Phase 2·NCT05634590·68 enrolled

Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer

Unknown status·SShanghai Zhongshan Hospital·Phase 2·NCT04296019·110 enrolled

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

Not yet recruiting·HHarbin Medical University·Phase 2·NCT07229872·18 enrolled

Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer

Recruiting·DDai, Guanghai·Phase 2·NCT06685276·46 enrolled

Fruquintinib Sequential BEV+FOLFIRI vs. BEV+FOLFIRI Sequential Fruquintinib in Metastatic Colorectal Cancer

Unknown status·WWeijian Guo·Phase 2·NCT05447715·134 enrolled

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

Recruiting·FFudan University·Phase 2·NCT05954429·50 enrolled

Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

Recruiting·FFudan University·Phase 2·NCT05771181·25 enrolled

Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

Completed·HHutchison Medipharma Limited·Phase 2·NCT02196688·71 enrolled

- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases

Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT06856837·140 enrolled

A Prospective Multi-centered Randomized Controlled Trial on Fruquintinib in Combination With HAIC in the Treatment of Liver Metastatic Colorectal Cancer After Failure of Second-line Systematic Therapy

Unknown status·—·Phase 2·NCT05511051·102 enrolled

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

Completed·HHutchison Medipharma Limited·Phase 3·NCT04322539·691 enrolled

Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

Recruiting·TThe First Affiliated Hospital of Nanchang University·Phase 4·NCT06118762·30 enrolled

Colorectal Cancer17 trials

Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer

Recruiting·SSun Yat-sen University·Phase 2/3·NCT06441565·84 enrolled

ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer

Recruiting·—·Phase 2·NCT06543836·68 enrolled

Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

Unknown status·PPeking University··NCT04431791·268 enrolled

Show 14 more trials

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

Not yet recruiting·YYe Xu·Phase 4·NCT07446465·42 enrolled

Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study

Recruiting·SSun Yat-sen University·Phase 2·NCT06018714·64 enrolled

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

Not yet recruiting·FFujian Cancer Hospital·Phase 2·NCT06218888·17 enrolled

A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients

Recruiting·CChipscreen Biosciences, Ltd.·Phase 3·NCT06497985·430 enrolled

TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

Unknown status·—··NCT05993702·45 enrolled

A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)

Completed·HHutchison Medipharma Limited·Phase 3·NCT02314819·416 enrolled

Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy

Unknown status·PPeking University Cancer Hospital & Institute·Phase 2·NCT05406206·27 enrolled

Phase II Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab as Third-line Therapy for Colorectal Cancer

Unknown status·—·Phase 2·NCT04179084·30 enrolled

Fruquintinib and Raltitrexed Versus Fruquintinib Monotherapy in Advanced Colorectal Cancer

Unknown status·FFudan University·Phase 2·NCT04582981·136 enrolled

A Multicenter, Open-label, Randomized Controlled Phase III Study Evaluating the Efficacy and Safety/Tolerability of GFH375 in Combination With Cetuximab Versus Investigator's Choice of Treatment in Patients With KRAS G12D Mutant Metastatic Colorectal Cancer Refractory to Oxaliplatin, Fluoropyrimidines, and Irinotecan

Not yet recruiting·GGenfleet Therapeutics (Shanghai) Inc.·Phase 3·NCT07913360·368 enrolled

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer

Recruiting·CCriterium, Inc.·Phase 2·NCT06992258·120 enrolled

A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07730489·130 enrolled

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

Recruiting·KKahr Bio Australia Pty Ltd·Phase 2·NCT07235293·90 enrolled

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

Recruiting· Takeda logo

Takeda·Approved·NCT06562543·78 enrolled

Fruquintinib9 trials

Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects

Completed·HHutchison Medipharma Limited·Phase 1·NCT01955304·20 enrolled

Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC

Recruiting·HHuazhong University of Science and Technology·Phase 2·NCT06168786·40 enrolled

Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC

Recruiting·LLiu Huang·N/A·NCT06551207·80 enrolled

Show 6 more trials

Fruquintinib CYP3A Inhibitor and Inducer Study

Completed·HHutchison Medipharma Limited·Phase 1·NCT04557397·28 enrolled

A Phase Ib Study of Fruquintinib in 3rd Line mCRC

Completed·HHutchison Medipharma Limited·Phase 1/2·NCT01975077·62 enrolled

A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion Of [14C] Fruquintinib

Completed·HHutchison Medipharma Limited·Phase 1·NCT02689752·6 enrolled

Fruquintinib DDI Study With P-gp and BCRP Substrates

Completed·HHutchmed·Phase 1·NCT05368805·32 enrolled

A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）

Completed·ZZhen-Yu Ding·Phase 2·NCT05025631·29 enrolled

Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC

Recruiting·MMeng Qiu·Phase 2·NCT06427005·66 enrolled

Gastric Cancer7 trials

Fruquintinib Plus Irinotecan in the Treatment of Advanced Gastric Cancer

Unknown status·FFujian Medical University·Phase 2·NCT05643677·47 enrolled

Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer

Recruiting·DDai, Guanghai·Phase 2·NCT07392346·68 enrolled

Envollizumab Combined With Fruquintinib and SOX Versus SOX for Conversion Therapy in Advanced Gastric Cancer

Not yet recruiting·FFujian Medical University·Phase 3·NCT05914610·100 enrolled

Show 4 more trials

A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG

Recruiting·HHenan Cancer Hospital·Phase 2·NCT06774222·69 enrolled

Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer

Unknown status·RRenJi Hospital·Phase 2·NCT05795296·30 enrolled

Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer

Recruiting·FFirst Affiliated Hospital of Fujian Medical University·Phase 2·NCT06791083·40 enrolled

A Randomized Controlled Study of 2nd-line Treatment of Advanced G/GEJ Adenocarcinoma With Fruquintinib and Albumin-paclitaxel in Combination With or Without PD-1 Antibody in Patients Who Have Failed Treatment With PD-1 Antibody

Recruiting·CCancer Institute and Hospital, Chinese Academy of Medical Sciences··NCT06417892·60 enrolled

Non-Small Cell Lung Cancer3 trials

A Phase III Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

Completed·HHutchison Medipharma Limited·Phase 3·NCT02691299·527 enrolled

A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

Completed·HHutchison Medipharma Limited·Phase 2·NCT02590965·91 enrolled

A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer

Completed·HHutchison Medipharma Limited·Phase 2·NCT02976116·50 enrolled

32 more indications

Soft Tissue Sarcoma3 trials

Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance

Completed·PPeking University People's Hospital··NCT06202599·124 enrolled

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

Recruiting·SShanghai 6th People's Hospital·Phase 2·NCT05941325·20 enrolled

Fruquintinib in the Treatment of Soft Tissue Sarcoma

Unknown status·FFudan University·Phase 2·NCT05142631·31 enrolled

Adenocarcinoma2 trials

Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma

Unknown status·SSichuan University·Phase 2·NCT04156958·33 enrolled

Fruquintinib Combined with Sintilimab As Second-line Therapy for Gastric or Gastro-esophageal Junction Adenocarcinoma

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT05625737·29 enrolled

Endometrial Cancer2 trials

Fruquintinib Combined With Standard Chemotherapy Versus Standard Chemotherapy as First-line Treatment for Advanced pMMR Endometrial Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07170982·128 enrolled

Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

Recruiting·HHutchmed·Phase 3·NCT06584032·412 enrolled

Hepatocellular Carcinoma2 trials

Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT06446154·36 enrolled

Phase II Study of Fruquintinib Combined With Sintilimab and TACE for Inoperable Primary Hepatocellular Carcinoma

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT05971199·27 enrolled

Radiotherapy1 trial

Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC

Unknown status·TThe First Affiliated Hospital of Xiamen University·Phase 2·NCT05292417·71 enrolled

Locally-advanced Rectal Cancer1 trial

Neoadjuvant Therapy for Locally Advanced Rectal Cancer With Fruquintinib, Toripalimab and SRT

Unknown status·WWest China Hospital·Phase 2·NCT05763927·44 enrolled

Patients With Advanced Solid Tumors1 trial

Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors

Completed·HHutchison Medipharma Limited·Phase 1·NCT01645215·40 enrolled

Advanced Cancer1 trial

Clinical Study of Fruquintinib Combined With Sintilimab and XELOX Regimen in the Treatment of Advanced Cancer

Not yet recruiting·SSecond Affiliated Hospital of Nanchang University·Phase 2·NCT06094868·45 enrolled

Hepatic Impairment1 trial

Fruquintinib Hepatic Impairment Study

Completed·HHutchmed·Phase 1·NCT05216367·16 enrolled

High Risk Patients1 trial

Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC

Withdrawn·HHutchison Medipharma Limited·Phase 2·NCT03684967

Selected Advanced Solid Tumors1 trial

A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Recruiting·AAskGene Pharma, Inc.·Phase 1/2·NCT05867420·594 enrolled

PD-1 Inhibitors1 trial

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Completed·HHunan Cancer Hospital··NCT06031376·106 enrolled

Pancreatic Cancer1 trial

A Phase II Clinical Trial of Fruquintinib as Third Line Treatment in Advanced Pancreatic Cancer

Unknown status·FFudan University·Phase 2·NCT05257122·32 enrolled

Esophageal Squamous Cell Carcinoma1 trial

Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Esophageal Squamous Cell Carcinoma

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT06646588·67 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors

Completed· BeiGene logo

BeiGene·Phase 2·NCT04716634·84 enrolled

Breast Cancer1 trial

A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers

Completed·HHutchison Medipharma Limited·Phase 1·NCT03251378·129 enrolled

Ovarian Cancer1 trial

Phase II Study of Utidelone Plus Fruquintinib Combination Therapy for Platinum-Resistant Recurrent Ovarian Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06973421·35 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib

Unknown status·GGenor Biopharma Co., Ltd.·Phase 1·NCT03976856·42 enrolled

Renal Impairment1 trial

Fruquintinib Renal Impairment Study

Completed·HHutchmed·Phase 1·NCT05216354·24 enrolled

Liver Metastases1 trial

Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Therapy

Unknown status·FFudan University·Phase 2·NCT05435313·39 enrolled

Advanced Malignancies1 trial

Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

Enrolling by invitation·BBeOne Medicines·Phase 3·NCT04164199·430 enrolled

Advanced Solid Tumors1 trial

A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors

Terminated·HHutchmed·Phase 1/2·NCT04577963·52 enrolled

Gastric Adenocarcinoma1 trial

Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

Recruiting·FFederation Francophone de Cancerologie Digestive·Phase 3·NCT07270991·324 enrolled

Refractory Metastatic Colorectal Cancer1 trial

A Phase II Study of Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment

Recruiting·RRenmin Hospital of Wuhan University·Phase 2·NCT07896096·33 enrolled

Rectal Neoplasms1 trial

Short-Course Radiotherapy Followed by Fruquintinib Plus Tislelizumab and CAPOX Versus Short-Course Radiotherapy Followed by Tislelizumab and CAPOX for Neoadjuvant Treatment of Locally Advanced Low Rectal Cancer: A Randomized Controlled Trial

Recruiting·RRuijin Hospital·Phase 2·NCT07888309·50 enrolled

Advanced Renal Cell Carcinoma1 trial

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)

Completed·HHutchmed·Preclinical·NCT05522231·265 enrolled

Metastatic Colorectal Carcinoma1 trial

An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma

Recruiting·NNanjing Leads Biolabs Co.,Ltd·Preclinical·NCT07791758·369 enrolled

Stomach Neoplasms1 trial

A Phase II Clinical Study of Irinotecan Liposome Combined With Fruquintinib and Sintilimab as Second-Line Therapy for PD-L1-Positive (CPS ≥ 1) Advanced Gastric Cancer

Not yet recruiting·CCancer Hospital Chinese Academy of Medical Science, Shenzhen Center·Phase 2·NCT07819019·20 enrolled

To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma1 trial

A Randomized Phase 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

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT06484153·25 enrolled

Minimal Residual Disease1 trial

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

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07136077·15 enrolled

Metastatic Colorectal Cancer (CRC)1 trial

A Phase II Study of Fruquintinib Combined With Anti-EGFR Monoclonal Antibody in Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer

Recruiting·CCancer Institute and Hospital, Chinese Academy of Medical Sciences·Phase 2·NCT07724223·46 enrolled

Colon Cancer1 trial

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

Active, not recruiting·SSapience Therapeutics·Phase 1·NCT05848739·130 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 8, 2023

FRUZAQLA

NDA NDA217564

Sources

References

[1]
ClinicalTrials.gov — 94 trial records for Fruquintinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Elunate drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fruquintinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fruquintinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217564). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Elunate. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Vascular Endothelial Growth Factor Receptor Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

May 9, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8212033May 9, 2028

7829574Mar 23, 2032

11046674Sep 7, 2035

10519142Sep 7, 2035

Elunate

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Metastatic Colorectal Cancer21 trials

Colorectal Cancer17 trials

Fruquintinib9 trials

Gastric Cancer7 trials

Non-Small Cell Lung Cancer3 trials

Soft Tissue Sarcoma3 trials

Adenocarcinoma2 trials

Endometrial Cancer2 trials

Hepatocellular Carcinoma2 trials

Radiotherapy1 trial

Locally-advanced Rectal Cancer1 trial

Patients With Advanced Solid Tumors1 trial

Advanced Cancer1 trial

Hepatic Impairment1 trial

High Risk Patients1 trial

Selected Advanced Solid Tumors1 trial

PD-1 Inhibitors1 trial

Pancreatic Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

Efficacy and Safety1 trial

Breast Cancer1 trial

Ovarian Cancer1 trial

Safety and Efficacy1 trial

Renal Impairment1 trial

Liver Metastases1 trial

Advanced Malignancies1 trial

Advanced Solid Tumors1 trial

Gastric Adenocarcinoma1 trial

Refractory Metastatic Colorectal Cancer1 trial

Rectal Neoplasms1 trial

Advanced Renal Cell Carcinoma1 trial

Metastatic Colorectal Carcinoma1 trial

Stomach Neoplasms1 trial

To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma1 trial

Minimal Residual Disease1 trial

Metastatic Colorectal Cancer (CRC)1 trial

Colon Cancer1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News