{"entity":{"id":"fruquintinib","kind":"drug","name":"Fruquintinib","aka":[],"tldr":"A Chinese-discovered pill that blocks the blood-vessel receptors, approved in 2023 for bowel cancer after all standard treatments.","summary":"Fruquintinib is an ATP-competitive inhibitor of VEGFR1, 2 and 3 with little activity on other kinases, discovered in China, that starves tumours of new blood vessels with fewer off-target effects than regorafenib. It is used for refractory metastatic colorectal cancer after fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF and, where appropriate, anti-EGFR therapy, taken 5 mg once daily for 21 days of a 28-day cycle. FRESCO (China, 2018) and FRESCO-2 (global, 2023) showed an overall survival benefit, 7.4 versus 4.8 months in FRESCO-2 (HR 0.66); FDA approval followed in November 2023 and EU approval in 2024. It is better tolerated than regorafenib; hypertension, hand-foot syndrome, proteinuria and hypothyroidism are the main toxicities. There is no head-to-head trial against regorafenib. For a newcomer, it is a late-line bowel cancer pill that adds a few months with manageable side effects.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Fruquintinib","links":[{"label":"FDA approval summary, Clinical Cancer Research","url":"https://aacrjournals.org/clincancerres/article/30/15/3100/746597/FDA-Approval-Summary-Fruquintinib-for-the"},{"label":"NICE TA1079: fruquintinib for previously treated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta1079"},{"label":"EMA Fruzaqla","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf"],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":["fresco-2","nct06199973","nct06584032","nct06497985","nct07235293","nct05565417","nct06992258","nct05405595","nct05867420","fresco"],"people":["su-weiguo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Fruzaqla","modality":"Small-molecule kinase inhibitor (VEGFR1-3)","mechanism":"ATP-competitive inhibition of VEGFR1, 2, and 3 tyrosine kinases.","approvals":[{"region":"China","year":2018,"indication":"Refractory mCRC (FRESCO)"},{"region":"US","year":2023,"indication":"Refractory mCRC after fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF, and anti-EGFR if appropriate"},{"region":"EU","year":2024,"indication":"Previously treated metastatic colorectal cancer","note":"Fruzaqla marketing authorisation issued 20 June 2024."},{"region":"England (NICE)","year":2025,"indication":"Metastatic colorectal cancer at third line or later, only when trifluridine-tipiracil with bevacizumab is unsuitable","note":"TA1079, published 23 July 2025, with a commercial arrangement; it must be funded in England within 90 days of publication."}],"mechanismSteps":["Fruquintinib enters blood-vessel cells and binds VEGFR kinases","VEGF signals can no longer be transmitted","Tumour vessel growth halts","Tumour growth slows; survival is extended modestly"],"dosing":{"route":"Oral","schedule":"5 mg once daily, days 1-21 of a 28-day cycle","modifications":"Reduce to 4 mg then 3 mg for toxicity","monitoring":"Blood pressure, urine protein, liver tests, thyroid","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf"},"toxicity":[{"event":"Hypertension","note":"Most common grade 3 event"},{"event":"Hand-foot syndrome"},{"event":"Proteinuria"},{"event":"Hypothyroidism"}],"access":[],"regulatoryEvents":[{"date":"2023-11-08","type":"approval","region":"US","note":"FRESCO-2"}]},"route":"/drugs/fruquintinib/","neighbours":{"cancer":[{"id":"braf-v600e-colorectal","kind":"cancer","name":"BRAF V600E-mutant colorectal cancer","route":"/cancers/braf-v600e-colorectal/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"kras-g12c-colorectal","kind":"cancer","name":"KRAS G12C-mutant colorectal cancer","route":"/cancers/kras-g12c-colorectal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"askgene-pharma","kind":"company","name":"AskGene Pharma","route":"/companies/askgene-pharma/"},{"id":"hutchmed","kind":"company","name":"Hutchmed","route":"/companies/hutchmed/"},{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"trial":[{"id":"nct06856837","kind":"trial","name":"- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorec","route":"/trials/nct06856837/"},{"id":"nct07502014","kind":"trial","name":"A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line","route":"/trials/nct07502014/"},{"id":"nct06979908","kind":"trial","name":"A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal C","route":"/trials/nct06979908/"},{"id":"nct07591597","kind":"trial","name":"A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus F","route":"/trials/nct07591597/"},{"id":"nct07621159","kind":"trial","name":"A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer","route":"/trials/nct07621159/"},{"id":"nct07229872","kind":"trial","name":"A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer","route":"/trials/nct07229872/"},{"id":"nct06218888","kind":"trial","name":"A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Micro","route":"/trials/nct06218888/"},{"id":"nct06746545","kind":"trial","name":"A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.","route":"/trials/nct06746545/"},{"id":"nct06992258","kind":"trial","name":"A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer","route":"/trials/nct06992258/"},{"id":"nct07730489","kind":"trial","name":"A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, F","route":"/trials/nct07730489/"},{"id":"nct05867420","kind":"trial","name":"A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.","route":"/trials/nct05867420/"},{"id":"nct07011576","kind":"trial","name":"A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","route":"/trials/nct07011576/"},{"id":"nct06497985","kind":"trial","name":"A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients","route":"/trials/nct06497985/"},{"id":"nct05954429","kind":"trial","name":"A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-cente","route":"/trials/nct05954429/"},{"id":"nct07235293","kind":"trial","name":"A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.","route":"/trials/nct07235293/"},{"id":"nct05405595","kind":"trial","name":"ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors","route":"/trials/nct05405595/"},{"id":"nct07130903","kind":"trial","name":"Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer","route":"/trials/nct07130903/"},{"id":"nct06168786","kind":"trial","name":"Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC","route":"/trials/nct06168786/"},{"id":"fresco","kind":"trial","name":"FRESCO","route":"/trials/fresco/"},{"id":"fresco-2","kind":"trial","name":"FRESCO-2","route":"/trials/fresco-2/"},{"id":"nct06484153","kind":"trial","name":"Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma","route":"/trials/nct06484153/"},{"id":"nct07510932","kind":"trial","name":"Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)","route":"/trials/nct07510932/"},{"id":"nct07724223","kind":"trial","name":"Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC","route":"/trials/nct07724223/"},{"id":"nct07362836","kind":"trial","name":"Fruquintinib Versus Bevacizumab Plus Chemotherapy in Second-Line RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS)","route":"/trials/nct07362836/"},{"id":"nct07051785","kind":"trial","name":"Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer","route":"/trials/nct07051785/"},{"id":"nct06441565","kind":"trial","name":"Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer","route":"/trials/nct06441565/"},{"id":"nct06980532","kind":"trial","name":"Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer","route":"/trials/nct06980532/"},{"id":"nct06199973","kind":"trial","name":"Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, ","route":"/trials/nct06199973/"},{"id":"nct06443671","kind":"trial","name":"Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer","route":"/trials/nct06443671/"},{"id":"nct07353268","kind":"trial","name":"Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerabil","route":"/trials/nct07353268/"},{"id":"nct06685276","kind":"trial","name":"Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer","route":"/trials/nct06685276/"},{"id":"nct07150403","kind":"trial","name":"Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal","route":"/trials/nct07150403/"},{"id":"nct07515820","kind":"trial","name":"SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study","route":"/trials/nct07515820/"},{"id":"nct06584032","kind":"trial","name":"Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer","route":"/trials/nct06584032/"},{"id":"nct05565417","kind":"trial","name":"Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas","route":"/trials/nct05565417/"},{"id":"nct05771181","kind":"trial","name":"Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients","route":"/trials/nct05771181/"}],"person":[{"id":"li-jin-fuscc","kind":"person","name":"Jin Li","route":"/people/li-jin-fuscc/"},{"id":"xu-rui-hua","kind":"person","name":"Rui-Hua Xu","route":"/people/xu-rui-hua/"},{"id":"kim-tae-won","kind":"person","name":"Tae Won Kim","route":"/people/kim-tae-won/"},{"id":"su-weiguo","kind":"person","name":"Weiguo Su","route":"/people/su-weiguo/"}],"paper":[{"id":"paper-dasari-fresco-2-fruquintinib-lancet-2023","kind":"paper","name":"Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2)","route":"/key-papers/paper-dasari-fresco-2-fruquintinib-lancet-2023/"}],"term":[{"id":"colorectal-uk-drug-access","kind":"term","name":"Colorectal cancer drugs in England: what NICE has recommended","route":"/terms/colorectal-uk-drug-access/"}],"pathway":[{"id":"colorectal-cancer-signalling","kind":"pathway","name":"Colorectal cancer (KEGG map)","route":"/pathways/colorectal-cancer-signalling/"},{"id":"angiogenic-switch","kind":"pathway","name":"The angiogenic switch & tumour vessels","route":"/pathways/angiogenic-switch/"}]}}