MedPath

Fruquintinib

Generic Name
Fruquintinib
Brand Names
Fruzaqla
Drug Type
Small Molecule
Chemical Formula
C21H19N3O5
CAS Number
1194506-26-7
Unique Ingredient Identifier
49DXG3M5ZW

Overview

Fruquintinib is under investigation for the treatment of NSCLC. Fruquintinib has been investigated for the treatment of ColoRectal Cancer.

Indication

本品单药适用于既往接受过氟尿嘧啶类、奥沙利铂和伊立替康为基础的化疗,以及既往接受过或不适合接受抗血管内皮生长因子(VEGF)治疗、抗表皮生长因子受体(EGFR)治疗(RAS野生型)的转移性结直肠癌(mCRC)患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/22
Not Applicable
Not yet recruiting
2025/08/19
Not Applicable
Not yet recruiting
2025/08/15
Not Applicable
Not yet recruiting
Federation Francophone de Cancerologie Digestive
2025/06/29
Not Applicable
Not yet recruiting
2025/06/09
Phase 2
Recruiting
2025/05/28
Phase 2
Not yet recruiting
2025/03/04
Phase 2
Not yet recruiting
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2025/01/24
Phase 2
Recruiting
2025/01/14
Phase 2
Recruiting
2024/11/12
Phase 2
Recruiting
Dai, Guanghai

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Takeda Pharmaceuticals America, Inc.
63020-225
ORAL
5 mg in 1 1
11/14/2023
Takeda Pharmaceuticals America, Inc.
63020-210
ORAL
1 mg in 1 1
11/14/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FRUZAQLA CAPSULE 5MG
SIN17113P
CAPSULE
5mg
10/17/2024
FRUZAQLA CAPSULE 1MG
SIN17114P
CAPSULE
1mg
10/17/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
FRUZAQLA fruquintinib 5 mg hard capsule bottle
422038
Medicine
A
10/1/2024
FRUZAQLA fruquintinib 1 mg hard capsule bottle
422039
Medicine
A
10/1/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
FRUZAQLA
takeda canada inc
02551462
Capsule - Oral
5 MG
10/30/2024
FRUZAQLA
takeda canada inc
02551454
Capsule - Oral
1 MG
10/30/2024

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
FRUZAQLA 5 MG CAPSULAS DURAS
1241827002
CÁPSULA DURA
Diagnóstico Hospitalario
Commercialized
FRUZAQLA 1 MG CAPSULAS DURAS
1241827001
CÁPSULA DURA
Diagnóstico Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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