Infigratinib

Infigratinib
Clinical data
Trade names	Truseltiq
Other names	BGJ-398
License data	US DailyMed: Infigratinib;
Pregnancy; category	AU: D; ;
Routes of; administration	By mouth
Drug class	Tyrosine kinase inhibitor
ATC code	L01EN03 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only) ; US: ℞-only ;
Identifiers
CAS Number	872511-34-7;
PubChem CID	53235510;
DrugBank	DB11886;
ChemSpider	26333103;
UNII	A4055ME1VK;
KEGG	D11589;
CompTox Dashboard (EPA)	DTXSID70236238 ;
Chemical and physical data
Formula	C26H31Cl2N7O3
Molar mass	560.48 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CCN1CCN(CC1)C2=CC=C(C=C2)NC3=CC(=NC=N3)N(C)C(=O)NC4=C(C(=CC(=C4Cl)OC)OC)Cl;
	InChI InChI=1S/C26H31Cl2N7O3/c1-5-34-10-12-35(13-11-34)18-8-6-17(7-9-18)31-21-15-22(30-16-29-21)33(2)26(36)32-25-23(27)19(37-3)14-20(38-4)24(25)28/h6-9,14-16H,5,10-13H2,1-4H3,(H,32,36)(H,29,30,31); Key:QADPYRIHXKWUSV-UHFFFAOYSA-N;

Infigratinib, sold under the brand name Truseltiq, is an anti-cancer medication used to treat cholangiocarcinoma (bile duct cancer).^[1]^[2]^[3]

Infigratinib is a kinase inhibitor targeting the fibroblast growth factor receptors FGFR1, FGFR2 and FGFR3^[4]^[2]^[3] It was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019,^[5] and it was approved for medical use in the United States in May 2021.^[3]

Medical uses[]

Infigratinib is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.^[2]

References[]

^ ^a ^b ^c "Truseltiq". Therapeutic Goods Administration (TGA). 22 November 2021. Retrieved 28 December 2021.
^ ^a ^b ^c ^d "Truseltiq- infigratinib capsule". DailyMed. Retrieved 10 June 2021.
^ ^a ^b ^c "BridgeBio Pharma's Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA Approval of Truseltiq (infigratinib) for Patients with Cholangiocarcinoma" (Press release). BridgeBio Pharma. 28 May 2021. Retrieved 28 May 2021 – via GlobeNewswire.
^ Botrus G, Raman P, Oliver T, Bekaii-Saab T (April 2021). "Infigratinib (BGJ398): an investigational agent for the treatment of FGFR-altered intrahepatic cholangiocarcinoma". Expert Opinion on Investigational Drugs. 30 (4): 309–316. doi:10.1080/13543784.2021.1864320. PMID 33307867. S2CID 229177726.
^ "Infigratinib Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 11 September 2019. Retrieved 30 May 2021.

External links[]

"Infigratinib". Drug Information Portal. U.S. National Library of Medicine.
Clinical trial number NCT02150967 for "A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma" at ClinicalTrials.gov

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[Truseltiq_APM_Summary-1] "Truseltiq". Therapeutic Goods Administration (TGA). 22 November 2021. Retrieved 28 December 2021.

[Truseltiq_FDA_label-2] "Truseltiq- infigratinib capsule". DailyMed. Retrieved 10 June 2021.

[BridgeBio_Pharma_PR-3] "BridgeBio Pharma's Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA Approval of Truseltiq (infigratinib) for Patients with Cholangiocarcinoma" (Press release). BridgeBio Pharma. 28 May 2021. Retrieved 28 May 2021 – via GlobeNewswire.

[pmid33307867-4] Botrus G, Raman P, Oliver T, Bekaii-Saab T (April 2021). "Infigratinib (BGJ398): an investigational agent for the treatment of FGFR-altered intrahepatic cholangiocarcinoma". Expert Opinion on Investigational Drugs. 30 (4): 309–316. doi:10.1080/13543784.2021.1864320. PMID 33307867. S2CID 229177726.

[5] "Infigratinib Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 11 September 2019. Retrieved 30 May 2021.

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