Drugs / Fruquintinib
last change 3 days ago re-read 2 minutes ago

Fruquintinib

Small molecule

Developed for
colorectal cancer · gastric cancer · gastroesophageal junction adenocarcinoma · colorectal carcinoma · gastric adenocarcinoma · non-small cell lung carcinoma · rectal cancer · colorectal adenocarcinoma
+30 more · endometrial cancer · esophageal squamous cell carcinoma · gastric neoplasm · metastasis from malignant tumor of colon · triple-negative breast carcinoma · cancer · carcinoma · colon carcinoma · colorectal neoplasm · gastroesophageal adenocarcinoma · hepatocellular carcinoma · melanoma · metastatic malignant neoplasm in the colon · neoplasm · renal cell carcinoma · biliary tract cancer · clear cell renal carcinoma · digestive system cancer · gastroesophageal cancer · hormone receptor-positive breast cancer · lung cancer · malignant colon neoplasm · malignant pancreatic neoplasm · neoplasm of esophagus · neoplastic disease or syndrome · nonpapillary renal cell carcinoma · rectal carcinoma · refractory malignant neoplasm · sarcoma · soft tissue sarcoma
Investigated by
Fudan University · Hutchison Medipharma Limited · Sun Yat-sen University · Hutchmed · Henan Cancer Hospital · BeiGene
+94 more · Liu Huang · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Zhejiang Cancer Hospital · Federation Francophone de Cancerologie Digestive · Fujian Cancer Hospital · Huazhong University of Science and Technology · Meng Qiu · Shanghai Zhongshan Hospital · Takeda Development Center Americas, Inc. · The First Affiliated Hospital with Nanjing Medical University · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Chinese Academy of Medical Sciences · Chinese PLA General Hospital · Dai, Guanghai · Fujian Medical University · Genor Biopharma Co., Ltd. · Harbin Medical University · Huangshi Central Hospital · Hubei Cancer Hospital · Peking Union Medical College Hospital · Peking University · Peking University Cancer Hospital & Institute · RenJi Hospital · Sichuan University · Takeda · The First Affiliated Hospital of Zhengzhou University · Tianjin Medical University Cancer Institute and Hospital · Aiping Zhou · Anyang Tumor Hospital · Barbara Ann Karmanos Cancer Institute · BeOne Medicines · Beijing Friendship Hospital · Beijing Xisike Clinical Oncology Research Foundation · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · China Medical University, China · Covance · Criterium, Inc. · First Affiliated Hospital of Fujian Medical University · Guangxi Medical University · Guangzhou First People's Hospital · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Hebei Medical University Fourth Hospital · Henan Provincial People's Hospital · Hunan Cancer Hospital · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Jiangsu Cancer Institute & Hospital · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Jing-yuan Fang, MD, Ph. D · Korea University Anam Hospital · M.D. Anderson Cancer Center · Nanfang Hospital, Southern Medical University · National Cancer Center Hospital East · Ningbo Medical Center Lihuili Hospital · Peking University First Hospital · Peking University Third Hospital · Qilu Pharmaceutical Co., Ltd. · Queling Liu · Renmin Hospital of Wuhan University · Rui-hua Xu, MD, PhD · Ruijin Hospital · SCRI Development Innovations, LLC · Sapience Therapeutics · Second Affiliated Hospital of Nanchang University · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shandong Cancer Hospital and Institute · Shanghai 6th People's Hospital · Shanghai Chest Hospital · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai Shengdi Pharmaceutical Co., Ltd · Shanxi Province Cancer Hospital · Shionogi · Sir Run Run Shaw Hospital · Sixth Affiliated Hospital, Sun Yat-sen University · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · all 100 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Fruzaqla 2024-06-20 europa.eu
Approved US (FDA) FRUZAQLA 2023-11-08 fda.gov

Trials 164 · started per year

today
US approved 2023
EU approved 2024
1
2
2
2
2
1
6
8
14
25
32
26
26
16
201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06380309 May 2024 → Dec 2025 overdue digestive system cancer Peking University Recruiting No outcome recorded
Phase 112 trials
Phase 1 NCT05848739 Jun 2023 → May 2026 overdue colorectal cancer Sapience Therapeutics Recruiting No outcome recorded
Phase 1 NCT05216354 Mar 2022 → Jun 2023 impaired renal function disease Hutchmed Completed No outcome recorded
Phase 1 NCT05216367 Mar → Oct 2022 Hutchmed Completed No outcome recorded
Phase 1 NCT05368805 Mar → Apr 2022 colorectal cancer Hutchmed Completed No outcome recorded
Phase 1 NCT04645940 Sep → Nov 2020 Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT04557397 Sep → Oct 2020 Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT03976856 Jul 2019 → Dec 2021 non-small cell lung carcinoma Genor Biopharma Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03977090 Apr 2019 → Dec 2021 colorectal cancer Genor Biopharma Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03251378 Dec 2017 → Dec 2022 hormone receptor-positive breast cancer, malignant colon neoplasm, rectal cancer, triple-negative breast carcinoma Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT02689752 Jul → Sep 2016 Hutchison Medipharma Limited Completed No outcome recorded
Phase 1/221 trials
Phase 1/2 NCT07621159 Jul 2026 → Nov 2027 expected colorectal cancer Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1/2 NCT07591597 May 2026 → Jul 2027 expected colorectal cancer National Cancer Center Hospital East Not yet recruiting No outcome recorded
Phase 1/2 NCT07025850 Aug 2025 → Jan 2027 expected colorectal carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 1/2 NCT06980532 Apr 2025 → Dec 2028 expected colorectal cancer Liu Huang Recruiting No outcome recorded
Phase 1/2 NCT06871527 Mar 2025 → Mar 2028 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Sixth Affiliated Hospital, Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 1/2 NCT06484153 Jul 2024 → Jul 2026 overdue Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting No outcome recorded
Phase 1/2 NCT06329973 Feb 2024 → Jun 2026 overdue gastroesophageal junction adenocarcinoma Henan Cancer Hospital Recruiting No outcome recorded
Phase 1/2 NCT07334431 Feb 2024 → Dec 2025 overdue gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Henan Cancer Hospital Recruiting No outcome recorded
Phase 1/2 NCT06195670 Jan 2024 → Jan 2026 overdue colorectal adenocarcinoma Zhejiang Cancer Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT06078670 Oct 2023 → Jun 2026 neoplasm Fujian Cancer Hospital Unknown No outcome recorded
Phase 2101 trials
Phase 2 NCT07689292 Jul 2026 → Aug 2027 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07622550 Jun 2026 → Dec 2027 expected colorectal cancer Jiangsu Cancer Institute & Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07658872 Jun 2026 → May 2027 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Sichuan University Not yet recruiting No outcome recorded
Phase 2 NCT07510932 May 2026 → Mar 2027 expected colon carcinoma Korea University Anam Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07502014 May 2026 → Dec 2028 expected colorectal cancer Huazhong University of Science and Technology Not yet recruiting No outcome recorded
Phase 2 NCT07515820 Apr 2026 → Jul 2027 expected colorectal cancer Meng Qiu Not yet recruiting No outcome recorded
Phase 2 NCT06889610 Mar 2026 → Dec 2027 expected colorectal cancer, melanoma, triple-negative breast carcinoma Fudan University Recruiting No outcome recorded
Phase 2 NCT07042685 Jan 2026 → Dec 2028 expected colorectal cancer The Methodist Hospital Research Institute Recruiting No outcome recorded
Phase 2 NCT07353268 Jan 2026 → Aug 2027 expected colorectal cancer Tao Zhang Not yet recruiting No outcome recorded
Phase 2 NCT07150403 Dec 2025 → Feb 2028 expected colorectal carcinoma Federation Francophone de Cancerologie Digestive Not yet recruiting No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT06977061 Jun 2025 → Jun 2026 overdue gastric neoplasm Queling Liu Not yet recruiting No outcome recorded
Phase 2/3 NCT06443671 Jun 2024 → Jun 2026 overdue rectal cancer Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2/3 NCT06441565 May 2024 → Dec 2025 overdue colorectal cancer Sun Yat-sen University Recruiting No outcome recorded
Phase 2/3 NCT05522231 Oct 2022 → Jan 2025 overdue renal cell carcinoma Hutchmed Active not recruiting No outcome recorded
Phase 39 trials
Phase 3 NCT07483684 Mar 2026 → Aug 2027 expected carcinoma Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07362836 Jan 2026 → Dec 2028 expected colorectal cancer Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT07270991 Dec 2025 → Nov 2030 expected gastroesophageal adenocarcinoma Federation Francophone de Cancerologie Digestive Recruiting No outcome recorded
Phase 3 NCT06584032 Dec 2024 → Jan 2029 expected endometrial cancer Hutchmed Recruiting No outcome recorded
Phase 3 NCT06199973 Mar 2024 → Apr 2026 overdue colorectal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT05914610 Sep 2023 → Jul 2025 overdue gastric cancer Fujian Medical University Not yet recruiting No outcome recorded
Phase 3 NCT04322539 Aug 2020 → Jul 2022 colorectal cancer, metastatic malignant neoplasm in the colon Hutchison Medipharma Limited Completed No outcome recorded
Phase 3 NCT04164199 Dec 2019 → May 2026 cancer BeOne Medicines Completed No outcome recorded
Phase 3 NCT03223376 Oct 2017 → Sep 2022 gastric cancer Hutchison Medipharma Limited Completed No outcome recorded
Phase 44 trials
Phase 4 NCT07446465 Mar 2026 → Jan 2027 expected colorectal cancer Ye Xu Not yet recruiting No outcome recorded
Phase 4 NCT06562543 Jan 2025 → Oct 2027 expected colorectal cancer Takeda Recruiting No outcome recorded
Phase 4 NCT06118762 Oct 2023 → Oct 2026 expected colorectal cancer The First Affiliated Hospital of Nanchang University Recruiting No outcome recorded
Phase 4 NCT05661357 Jan 2023 → Jan 2025 colorectal cancer Zhongnan Hospital Unknown No outcome recorded
Phase not applicable11 trials
NCT07552402 Jun 2026 → Dec 2027 expected gastroesophageal junction adenocarcinoma Harbin Medical University Recruiting No outcome recorded
NCT07124858 Mar 2026 → Mar 2031 expected colorectal cancer Federation Francophone de Cancerologie Digestive Recruiting No outcome recorded
NCT06985316 May 2025 → Apr 2028 expected colorectal cancer Liu Huang Not yet recruiting No outcome recorded
NCT06553781 Sep 2024 → Sep 2025 overdue melanoma Fudan University Not yet recruiting No outcome recorded
NCT06551207 Aug 2024 → Dec 2026 expected colorectal cancer Liu Huang Recruiting No outcome recorded
NCT06613113 Aug 2024 → Apr 2025 overdue colorectal cancer Ningbo Medical Center Lihuili Hospital Recruiting No outcome recorded
NCT06317298 Feb 2024 → Aug 2025 clear cell renal carcinoma Peking University First Hospital Unknown No outcome recorded
NCT06199232 Jan 2024 → Jun 2026 overdue metastasis from malignant tumor of colon Peking University Active not recruiting No outcome recorded
NCT06115733 Dec 2023 → Dec 2026 expected colorectal carcinoma Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
NCT06158919 Nov 2023 → Nov 2024 overdue gastroesophageal junction adenocarcinoma Fudan University Recruiting No outcome recorded
Phase not stated1 trial
NCT06195514 colorectal cancer Takeda No longer available No outcome recorded
Also used as a comparator or background therapy in 13 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06347198 Background Apr → Dec 2024 colorectal cancer Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Unknown No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05867420 Background Aug 2023 → Dec 2026 expected cancer AskGene Pharma, Inc. Recruiting No outcome recorded
Phase 1/2 NCT05565417 Background Nov 2022 → Jan 2026 overdue Burkitt lymphoma, Hodgkins lymphoma, colorectal cancer, diffuse large B-cell lymphoma +8 Immunitas Therapeutics Active not recruiting No outcome recorded
Phase 1/2 NCT05405595 Background Jun 2022 → Oct 2026 expected Adagene Inc Recruiting No outcome recorded
Phase 25 trials
Phase 2 NCT07535632 Comparator Jun 2026 → Jun 2028 expected colorectal neoplasm Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07235293 Comparator Jan → Sep 2026 expected colorectal cancer Kahr Bio Australia Pty Ltd Recruiting No outcome recorded
Phase 2 NCT07257653 Background Oct 2025 → Dec 2026 expected colorectal adenocarcinoma Zhejiang University Recruiting No outcome recorded
Phase 2 NCT05511051 Background Feb 2022 → Aug 2024 colorectal cancer Cancer Institute and Hospital, Chinese Academy of Medical Sciences Unknown No outcome recorded
Phase 2 NCT02196688 Comparator Apr 2014 → Apr 2015 colorectal cancer Hutchison Medipharma Limited Completed No outcome recorded
Phase 34 trials
Phase 3 NCT07384377 Comparator Feb 2026 → Nov 2027 expected carcinoma Shanghai JMT-Bio Inc. Not yet recruiting No outcome recorded
Phase 3 NCT06497985 Comparator Dec 2024 → May 2028 expected colorectal cancer Chipscreen Biosciences, Ltd. Recruiting No outcome recorded
Phase 3 NCT02691299 Comparator Dec 2015 → Sep 2018 non-small cell lung carcinoma Hutchison Medipharma Limited Completed No outcome recorded
Phase 3 NCT02314819 Comparator Dec 2014 → Jan 2017 colorectal cancer Hutchison Medipharma Limited Completed No outcome recorded

Press releases naming this drug 7 releases

DateIssuerRelease
2024-09-24 Takeda Takeda Receives Approval for FRUZAQLA (fruquintinib) in Japan for the Treatment of Unresectable Advanced or Recurrent Colorectal Cancer takeda.com
2024-06-21 Takeda Takeda Receives Approval from European Commission for FRUZAQLA in Previously Treated Metastatic Colorectal Cancer takeda.com
2024-04-26 Takeda Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer takeda.com
2023-11-08 Takeda Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer takeda.com
2023-06-15 Takeda Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency takeda.com
2023-05-25 Takeda Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review takeda.com
2023-01-23 Takeda Takeda To Acquire Exclusive Worldwide (ex-China) License of HUTCHMED’s Fruquintinib, a Highly Selective, Oral VEGFR1/2/3 Tyrosine Kinase Inhibitor takeda.com

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 181 sources stand behind the page.

FieldValueCited text
Known as Fruquintinib “Phase II Clinical Study of Digoxin Combined With Fruquintinib and Tislelizumab in Patients With Advanced Primary Colorectal Cancer Who Failed Standard Therapy” NCT07025850
175

Fruquintinib (Group B, KRAS/NRAS/BRAF/EGFR mutation type and wide type but treated with cetuximab in last 3 months): 3 mg/d, d3-23, then suspend for 1w.” NCT06199232

Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection are administered until disease progression or toxicity intolerable.” NCT07392346

Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, has approved for the third-line treatment of refractory colorectal cancer.” NCT05842525

“All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle” NCT07024537

“combination therapy with IDOV-SAFE + Toripalimab + Fruquintinib after progression on IDOV-SAFETM monotherapy.” NCT06380309

“Multimodal ablation combined with cadonilimab and fruquintinibNCT06889610

Fruquintinib 5mg or regorafenib 120mg, qd po, 3 weeks, Q4w.” NCT04483219

Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w” NCT06195670

Fruquintinib:5mg,po.qd,Day1\~21, repeat every 28 days” NCT04446091

“Fuquinitinib capsule (Aiutec, Fruquintinib)” NCT06078670

Fruquintinib: 4mg po” NCT06513221

NCT06218888

NCT06234007

NCT05555901

NCT06985316

NCT06158919

NCT06977061

NCT05575635

NCT06199973

NCT06406426

NCT07621159

NCT06443671

NCT06980532

NCT05795296

NCT06992258

NCT06347198

NCT04164199

NCT05763927

NCT06091423

NCT06551207

NCT05168527

NCT06423937

NCT05122091

NCT07535632

NCT05292417

NCT04645940

NCT05661357

NCT07446465

NCT05177068

NCT05982834

NCT03976856

NCT04989855

NCT05016869

NCT05643677

NCT06888037

NCT05941325

NCT06746545

NCT06553781

NCT02196688

NCT06484153

NCT05241899

NCT05914610

NCT07257653

NCT04557397

NCT07362836

NCT05004441

NCT05721651

NCT07491159

NCT06973421

NCT06427005

NCT07286695

NCT05625737

NCT05447715

NCT06018714

NCT06317298

NCT06871527

NCT07488533

NCT06584032

NCT02976116

NCT05004831

NCT06856837

NCT07515820

NCT05771181

NCT06791083

NCT05565417

NCT04296019

NCT07124858

NCT04956146

NCT07150403

NCT05928312

NCT07510932

NCT06010212

NCT07136077

NCT06685276

NCT04577963

NCT06979908

NCT06706895

NCT06094868

NCT05257122

NCT06010888

NCT05831891

NCT06118762

NCT05405595

NCT02689752

NCT02314819

NCT01645215

NCT05522231

NCT05571644

NCT05511051

NCT04156958

NCT06115733

NCT02691299

NCT02415023

NCT05406206

NCT05848739

NCT04179084

NCT05025631

NCT05522738

NCT06487702

NCT05747716

NCT06356597

NCT06613113

NCT07270991

NCT06646588

NCT01955304

NCT07591597

NCT05659290

NCT07003022

NCT04582981

NCT05216354

NCT03977090

NCT05142631

NCT05216367

NCT07051785

NCT07235293

NCT07130903

NCT07502014

NCT07622550

NCT05024812

NCT03223376

NCT06497985

NCT04924179

NCT06774222

NCT07658872

NCT06168786

NCT03684967

NCT04695470

NCT06543836

NCT05435313

NCT06148402

NCT07483684

NCT04866108

NCT04322539

NCT07170982

NCT07042685

NCT06562543

NCT04866862

NCT05971199

NCT05954429

NCT04948034

NCT07229872

NCT04716634

NCT01975077

NCT07689292

NCT05634590

NCT05690035

NCT07334431

NCT07552402

NCT03903705

NCT04733963

NCT05451719

NCT07261709

NCT02590965

NCT06446154

NCT05368805

NCT07011576

NCT06329973

NCT06441565

NCT06356584

NCT05867420

NCT07384377

NCT05636150

NCT05279677

NCT07353268

NCT03251378

Known as Aiutec “Fuquinitinib capsule (Aiutec, Fruquintinib)” NCT06078670
Known as ELUNATE “Fruquintinib (Elunate®) is an orally available, potent and highly selective small molecule inhibitor of VEGFR-1, -2 and -3 that was discovered and developed by Hutchison...” PMID 30357594 Nov 2018
2

“Fruquintinib (trade name: Elunate) is a novel small molecule tyrosine kinase inhibitor.” NCT04156958

“Fruquintinib (ELUNATE®) is a novel kinase inhibitor” PMID 36623495 Jan 2023

Known as Fruquintinib Capsules Fruquintinib Capsules:4 mg / day, orally once daily on days 1-14 in 21-day cycles.” NCT06706895
Known as fruquintinib+chemotherapy ClinicalTrials.gov intervention name — accepted as the source's own label NCT07362836
1

NCT05555901

Known as Fruzaqla ChEMBL registry synonym — accepted as the source's own label CHEMBL4303214
Known as HMPL-013 “whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).” NCT06584032
2

“Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC” NCT03684967

“Fruquintinib (HMPL-013) is a novel oral small molecule compound” PMID 27299749 Jun 2016

Known as TAK-113 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06195514
Action Inhibit “selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3” NCT01645215
Modality Small molecule “novel oral small moleculeNCT01645215
Route Oral “continuous oral dosing” NCT01645215