Overview
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
Research Report
Infigratinib (Truseltiq): A Comprehensive Oncological and Regulatory Review
1. Infigratinib: Overview and Physicochemical Properties
1.1. Introduction to Infigratinib (Truseltiq)
Infigratinib, which was marketed under the brand name Truseltiq, is an orally bioavailable small-molecule kinase inhibitor.[1] It was developed as a targeted therapeutic agent for cancers characterized by aberrations in the fibroblast growth factor receptor (FGFR) signaling pathway, with a primary focus on cholangiocarcinoma (CCA).[1] The development and initial approval of Infigratinib represent the broader shift in oncology towards precision medicine, where treatments are increasingly tailored to specific genetic alterations within a patient's tumor. This paradigm necessitates molecular profiling of tumors to identify eligible patients, moving away from a one-size-fits-all approach.[1] The trajectory of Infigratinib, from its development through to accelerated and conditional approvals for a rare cancer indication, was notably rapid, reflecting the urgent unmet medical need in this patient population.[1] However, this expedited pathway also imposed obligations for post-marketing confirmatory studies, which ultimately presented significant challenges.[7]
1.2. Chemical Identity
The precise chemical identification of a drug substance is paramount for scientific discourse, regulatory documentation, and intellectual property protection.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/13 | Phase 3 | Recruiting | |||
2025/03/25 | Phase 2 | ENROLLING_BY_INVITATION | |||
2024/01/16 | Phase 2 | Terminated | |||
2023/12/11 | Phase 3 | Active, not recruiting | |||
2022/08/25 | Phase 2 | Withdrawn | |||
2022/08/22 | Phase 1 | Withdrawn | |||
2022/02/03 | Phase 1 | Withdrawn | |||
2021/12/06 | Phase 2 | ENROLLING_BY_INVITATION | |||
2021/08/25 | Phase 2 | UNKNOWN | |||
2021/07/22 | Phase 1 | Withdrawn | Guru P. Sonpavde |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| QED Therapeutics, Inc. | 72730-111 | ORAL | 100 mg in 1 1 | 6/3/2021 | |
| QED Therapeutics, Inc. | 72730-506 | ORAL | 50 mg in 1 1 | 6/3/2021 | |
| QED Therapeutics, Inc. | 72730-202 | ORAL | 75 mg in 1 1 | 6/3/2021 | |
| QED Therapeutics, Inc. | 72730-101 | ORAL | 125 mg in 1 1 | 6/3/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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