Infigratinib

Generic Name: Infigratinib

Brand Names: Truseltiq

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₃₁Cl_₂N_₇O_₃

CAS Number: 872511-34-7

Unique Ingredient Identifier: A4055ME1VK

Background: Infigratinib is a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor. By inhibiting the FGFR pathway, which is often aberrated in cancers such as cholangiocarcinoma, infigratinib suppresses tumour growth. Cholangiocarcinoma is the most common primary malignancy affecting the biliary tract and the second most common primary hepatic malignancy. Infitratinib is a pan-FGFR inhibitor, as it is an ATP-competitive inhibitor of all four FGFR receptor subtypes.

On May 28, 2021, the FDA granted accelerated approval to infigratinib - under the market name Truseltiq - for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in adults with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test. This approval follows pemigatinib, another FGFR inhibitor approved by the FDA for the same therapeutic indication.

Indication: Infigratinib is indicated for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in adults with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test.

Associated Conditions: Unresectable, locally advanced Cholangiocarcinomas, Unresectable, metastatic Cholangiocarcinomas

Clinical Trials

Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）

Phase 3

Recruiting

Conditions: Achondroplasia

Interventions: Drug: KK8398

First Posted Date: 2025-04-13

Last Posted Date: 2025-04-29

Lead Sponsor: Kyowa Kirin Co., Ltd.

Target Recruit Count: 6

Registration Number: NCT06926491

Locations: 🇯🇵
Aichi Children's Health and Medical Center, Ōbu, Aichi, Japan
🇯🇵
Osaka University Hospital, Suita, Osaka, Japan
🇯🇵
Osaka Women's and Children's Hospital, Waizumi, Osaka, Japan

and more 6 locations

An Interventional Study of Infigratinib in Children With Hypochondroplasia

Phase 2

Conditions: Hypochondroplasia

Interventions: Drug: infigratinib 0.128 mg/kg/day
Drug: infigratinib 0.25 mg/kg/day

First Posted Date: 2025-03-25

Last Posted Date: 2025-04-01

Lead Sponsor: QED Therapeutics, Inc.

Target Recruit Count: 24

Registration Number: NCT06873035

Locations: 🇳🇴
Haukeland University Hospital, Bergen, Norway
🇳🇴
Paediatric Clinical Research Unit at Osla University Hospital, Oslo, Norway
🇵🇹
Hospital Pediátrico de Coimbra, Coimbra, Portugal

and more 19 locations

Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

Phase 2

Terminated

Conditions: Gastroesophageal Junction Adenocarcinoma
Gastric Cancer

Interventions: Drug: Infigratinib

First Posted Date: 2024-01-16

Last Posted Date: 2024-08-14

Lead Sponsor: LianBio LLC

Target Recruit Count: 6

Registration Number: NCT06206278

Locations: 🇨🇳
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
🇨🇳
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
🇨🇳
The Second Hospital Lanzhou University, Lanzhou, Gansu, China

and more 27 locations

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

Phase 3

Active, not recruiting

Conditions: Achondroplasia

Interventions: Drug: Infigratinib 0.25 mg/kg/day
Drug: Placebo Comparator 0.25 mg/kg/day

First Posted Date: 2023-12-11

Last Posted Date: 2025-04-15

Lead Sponsor: QED Therapeutics, Inc.

Target Recruit Count: 110

Registration Number: NCT06164951

Locations: 🇬🇧
QED Investigative Site, Sheffield, United Kingdom

Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial

Phase 2

Withdrawn

Conditions: Resectable Intrahepatic Cholangiocarcinoma
Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8
Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Stage I Intrahepatic Cholangiocarcinoma AJCC v8
Stage II Intrahepatic Cholangiocarcinoma AJCC v8

Interventions: Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Drug: Infigratinib Phosphate
Drug: Nab-paclitaxel

First Posted Date: 2022-08-25

Last Posted Date: 2023-12-26

Lead Sponsor: Emory University

Registration Number: NCT05514912

Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Phase 1

Withdrawn

Conditions: Liver Cancer
Cholangiocarcinoma

Interventions: Drug: Infigratinib
Drug: Atezolizumab
Drug: Bevacizumab

First Posted Date: 2022-08-22

Last Posted Date: 2023-08-15

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT05510427

Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

Phase 1

Withdrawn

Conditions: Advanced Solid Tumor
CNS Tumor
Recurrent WHO Grade II Glioma

Interventions: Drug: Infigratinib

First Posted Date: 2022-02-03

Last Posted Date: 2023-02-23

Lead Sponsor: Helsinn Healthcare SA

Registration Number: NCT05222165

Locations: 🇨🇦
McMaster Children's Hospital (MCH), Hamilton, Ontario, Canada
🇨🇦
University of Alberta - Stollery Children's Hospital (SCH), Edmonton, Alberta, Canada
🇺🇸
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States

and more 7 locations

Extension Study of Infigratinib in Children With Achondroplasia (ACH)

Phase 2

Conditions: Achondroplasia

Interventions: Drug: Infigratinib

First Posted Date: 2021-12-06

Last Posted Date: 2025-04-23

Lead Sponsor: QED Therapeutics, Inc.

Target Recruit Count: 300

Registration Number: NCT05145010

Locations: 🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States
🇺🇸
USCF Benioff Children's Hospital, Oakland, Oakland, California, United States
🇺🇸
Nemours Alfred I. Dupont Hospital for Children, Wilmington, Delaware, United States

and more 19 locations

Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Phase 2

Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Solid Tumor

Interventions: Drug: Infigratinib

First Posted Date: 2021-08-25

Last Posted Date: 2022-06-27

Lead Sponsor: LianBio LLC

Target Recruit Count: 80

Registration Number: NCT05019794

Locations: 🇨🇳
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
🇨🇳
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
🇨🇳
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China

and more 14 locations

Phase I BLASST-3 Trial

Phase 1

Withdrawn

Conditions: Bladder Transitional Cell Carcinoma
Bladder Cancer
Fibroblast Growth Factor Receptor

Interventions: Drug: Infigratinib

First Posted Date: 2021-07-22

Last Posted Date: 2022-08-10

Lead Sponsor: Guru P. Sonpavde

Registration Number: NCT04972253

Drug Development Updates

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