fruquintinib

Trade name: Fruzaqla

Small moleculeapprovedFast Track FDA

Approved

Nov 8, 2023

Clinical trial activity

147 trials · 59 clinical orgs · 1 marketing orgs

Phase 1
27
Phase 2
117
Phase 3
13
Phase 4
4

Earliest trial started Jan 1, 2011 (NCT01645215)

Timeline

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Nov 8, 2023

    Takeda — Earliest FDA Approval

  2. Nov 8, 2023

    Takeda — NDA Organization

  3. Nov 8, 2023

    Takeda — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewFast trackNov 8, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CNC(=O)c1c(C)oc2cc(Oc3ncnc4cc(OC)c(OC)cc34)ccc12
Mol. weight
393.4 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • fruquintinib
  • fruquintinib
  • fruquintinib
  • fruquintinib
  • fruquintinib
  • fruquitinib
  • hmpl-013
  • hmpl-013
  • hmpl-013

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07124858N/AMar 1, 2026Federation Francophone de Cancerologie Digestive
NCT07286695Phase 2Dec 31, 2025Chinese Academy of Medical Sciences
NCT07270991Phase 3Dec 31, 2025Federation Francophone de Cancerologie Digestive, Takeda
NCT07229872Phase 2Dec 31, 2025Harbin Medical University
NCT07150403Phase 2Dec 31, 2025Federation Francophone de Cancerologie Digestive
NCT07261709Phase 2Dec 1, 2025Sun Yat-Sen University
NCT07235293Phase 2Nov 15, 2025Kahr Medical, Novotech
NCT07257653Phase 2Oct 21, 2025Zhejiang University
NCT07170982Phase 2Oct 15, 2025Sun Yat-Sen University
NCT07011576Phase 2Sep 29, 2025SCRI Development Innovations, Takeda
NCT07136077Phase 2Sep 18, 2025BeOne Medicines, University of Texas at Houston
NCT06992258Phase 2Sep 15, 2025Criterium, Inc.
NCT07130903Phase 2Sep 10, 2025THERABIONIC INC., Wayne State University
NCT07042685Phase 2Aug 31, 2025Methodist Cancer Center, Houston, Texas, Takeda, The University of Texas, Dallas
NCT07025850Phase 1/Phase 2 (Phase 2)Aug 1, 2025Anyang Regional Hospital, Fudan University
NCT07051785Phase 2Jul 7, 2025Huazhong University of Science and Technology
NCT06973421Phase 2Jul 1, 2025Fudan University
NCT06977061Phase 2/Phase 3 (Phase 3)Jun 1, 2025Nanchang University
NCT07003022Phase 2Jun 1, 2025Fudan University
NCT06985316N/AMay 19, 2025Huazhong University of Science and Technology
Showing 20 of 147 trials
Page 1 / 8

Organizations

Research & Development (59)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Fudan UniversityAcademic/Hospital302342011
Hutchison MediPharmaFor profit252042011
Sun Yat-Sen UniversityAcademic/Hospital141022012
Huazhong University of Science and TechnologyAcademic/Hospital121132019
Chinese Academy of Medical SciencesAcademic/Hospital9922020
Jiao Tong UniversityAcademic/Hospital8632014
Fujian Medical UniversityAcademic/Hospital5522022
Sichuan UniversityAcademic/Hospital5512019
TakedaFor profit5242024
University of WashingtonAcademic/Hospital5432022
BeOne MedicinesFor profit4112021
Henan Medical UniversityAcademic/Hospital4312021
Nanjing Medical UniversityAcademic/Hospital4412021
People's Liberation Army of ChinaGovernment4322014
Zhejiang UniversityAcademic/Hospital4222021
Federation Francophone de Cancerologie DigestiveAcademic/Hospital3332025
Nanchang UniversityAcademic/Hospital3332023
Peking UniversityAcademic/Hospital3332022
Xiamen UniversityAcademic/Hospital3222021
Genor BioPharma Co., Ltd.For profit2212019
59 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
TakedaFor profitNDANov 8, 2023
TakedaFor profitMKTGNov 8, 2023