Drug · Small Molecule

Infigratinib

CI-DRUG-00000302Explore in graph →NCIt C88302 CHEMBL1852688 CIViC Approved

Regulatory

Approvals (4)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520648) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 23, 2023	—	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520656) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 23, 2023	—	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520621) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Market

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 15 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Withdrawn	Phase 3	2	24	4	CA	—	Dec 11, 2009
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	0	2	0	—	—	Dec 9, 2013
Malignant Gastric Neoplasm	Phase2	Phase 2	0	2	0	—	—	May 13, 2020
Malignant Liver Neoplasm	Phase2	Phase 2	0	2	0

Curated evidence

Clinical evidence (30)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–30 of 30 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FGFR1 Amplification3
Infigratinib	Bladder Carcinoma

Clinical trials

Trials with this intervention (24)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–24 of 24 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02657486	BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder	completed	N/A	4	Memorial Sloan Kettering Cancer CenterOTHER	1	Sep 2, 2026	clinicaltrials
NCT04233567	Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations	completed	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Fibroblast growth factor receptor inhibitor
Targets: 4 genes
Aliases: 3-(2,6-Dichloro-3,5-dimethoxyphenyl)-1-(6-((4-(4-ethylpiperazin-1-yl)phenyl)amino)pyrimidin-4-yl)-1-methylurea, BGJ 398, BGJ-398, BGJ398, BGJ398 (NVP-BGJ398), BGJ398 (NVP-BGJ398|INFIGRATINIB), Infigratinib, INFIGRATINIB (BGJ398), Infigratinib Phosphate, KIN001-271, MVP-BGJ398, NVP-BGJ398, NVP-BGJ398CT-BGJ398BGJ-398BGJ3983-(2,6-DICHLORO-3,5-DIMETHOXYPHENYL)-1-(6-(4-(4-ETHYLPIPERAZIN-1-YL)PHENYLAMINO)PYRIMIDIN-4-YL)-1-METHYLUREA, TRUSELTIQ

Data updated 24 hours agoSource updated unknown

Identifiers

Codes (9)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EN03	INFIGRATINIB
DIN (Health Canada)	02520621	TRUSELTIQ

FGFR3 Mutation1
Infigratinib	Bladder Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID1910 Phase 1 study evaluated 132 patients who had advanced cancer with FGFR-aberrations treated with FGFR-inhibitor BGJ398. In the subgroup of eight patients with FGFR3-mutated bladder/urothelial cancer tr… (full text at CIViC) PMID 27870574 · Nogova et al., 2017 · Open in CIViC	civic

FGFR3 Mutation1

Infigratinib

Bladder Carcinoma

Predictive

Supports Sensitivity Response

accepted

EID1910

Phase 1 study evaluated 132 patients who had advanced cancer with FGFR-aberrations treated with FGFR-inhibitor BGJ398. In the subgroup of eight patients with FGFR3-mutated bladder/urothelial cancer tr… (full text at CIViC)

PMID 27870574 · Nogova et al., 2017 · Open in CIViC

FGFR2 Mutation2
Infigratinib	Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID5912 Eight patients with cholangiocarcinoma haboring FGFR2 mutations received BGJ398. No response was observed, but one tumor showed a 23% reduction in size. Water fall plot of this article showed 5 patie… (full text at CIViC) PMID 29182496 · Javle et al., 2018 · Open in CIViC	civic
〃	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1912 Phase 1 study of FGFR-inhibitor BGJ398 in advanced cancer with FGFR-aberrations. Among three patients with cholangiocarcinoma and FGFR2 aberrations (2 fusions, 1 mutation), all three had stable diseas… (full text at CIViC) PMID 27870574 · Nogova et al., 2017 · Open in CIViC	civic

FGFR1 Expression4
Infigratinib	Gastric Adenocarcinoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID800 FGFR inhibitor BGJ398 was most effective in a gastric cancer cell line model with high expression of FGFR1 and FGFR2IIIc. PMID 26637881 · Schmidt et al., 2015 · Open in CIViC	civic
〃	Head and Neck Squamous Cell Carcinoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID799 FGFR1 mRNA expression, rather than copy number alterations, were predictive of response to FGFR inhibitor BGJ398 in cell lines and patient derived xenografts. PMID 26015511 · Göke et al., 2015 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID896 In vitro studies showed efficacy of FGFR inhibitor NVP-BGJ398 in cell lines exhibiting high FGFR1 protein. Three cell lines (SNU-C1, HDC9, HCT116) were analyzed. FGFR1 amplification (24/454, assessed … (full text at CIViC) PMID 24135816 · Göke et al., 2013 · Open in CIViC	civic
Fexagratinib + FGF/VEGF Receptor Tyrosine Kinase Inhibitor, PD173074 + InfigratinibSubstitutes	Sarcoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID2915 Targeting of FGFR1 by RNA interference and small-molecule inhibitors (PD173074, AZD4547, BGJ398) revealed that the requirement for FGFR1 signaling in STS cells is dictated by FGFR1 expression levels, … (full text at CIViC) PMID 27535980 · Chudasama et al., 2017 · Open in CIViC	civic

FGFR3 S249C2
Infigratinib + PD173074Substitutes	Lung Adenocarcinoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID4871 In this study, 363 lung adenocarcinoma tumors of Indian origin were analyzed using targeted next-generation sequencing and mass spectrometry genotyping, and FGFR3 mutations were identified in 20 tumor… (full text at CIViC) PMID 27998968 · Chandrani et al., 2017 · Open in CIViC	civic
Infigratinib	Transitional Cell Carcinoma	Predictive	B	Supports Sensitivity Response	4	submitted	EID6404 In this one-arm study, 67 patients with metastastic urothelial carcinoma and diverse FGFR3 alterations were treated with pan-FGFR Inhibitor BGJ398. The majority of patients (70.1%) had received two or… (full text at CIViC) PMID 29848605 · Pal et al., 2018 · Open in CIViC	civic

FGFR3 G370C2
Infigratinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	submitted	EID13174 In a preclinical MANO drug-sensitivity assay, 3T3 cells expressing FGFR3 G370C were treated with infigratinib for 5 days. Infigratinib inhibited FGFR3 G370C-expressing cells with an estimated IC50 of … (full text at CIViC) PMID 34272467 · Nakamura et al., 2021 · Open in CIViC	civic
〃	Transitional Cell Carcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID6414 In this one-arm study, 67 patients with metastastic urothelial carcinoma and diverse FGFR3 alterations were treated with pan-FGFR Inhibitor BGJ398. The majority of patients (70.1%) had received two or… (full text at CIViC) PMID 29848605 · Pal et al., 2018 · Open in CIViC	civic