{"entity":{"id":"infigratinib","kind":"drug","name":"Infigratinib","aka":["BGJ398"],"tldr":"Infigratinib is an FGFR inhibitor pill given accelerated approval in the United States in 2021 for bile duct cancer with an FGFR2 fusion, then withdrawn in 2024 when its confirmatory trial could not enrol; it is now being developed for achondroplasia instead.","summary":"Infigratinib, discovered at Novartis and developed by BridgeBio's QED Therapeutics with Helsinn, received FDA accelerated approval in May 2021 for previously treated, unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement, on a response rate of about 23 percent in a single-arm phase 2 trial. The first-line confirmatory trial PROOF 301 struggled to recruit against pemigatinib and futibatinib, and the sponsors withdrew the cholangiocarcinoma indication in 2024. Hyperphosphataemia, eye and nail changes are the FGFR class effects. BridgeBio continues the molecule at low dose for children with achondroplasia.","status":"withdrawn","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Infigratinib","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Infigratinib"},{"label":"ChEMBL CHEMBL1852688","url":"https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688"}],"tags":["gap-fill","chembl-universe"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["pemigatinib","futibatinib"],"companies":["bridgebio-oncology-therapeutics","helsinn"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"brand":"Truseltiq","modality":"Oral FGFR1 to 3 kinase inhibitor","mechanism":"An ATP-competitive inhibitor of FGFR1, FGFR2 and FGFR3 kinases; tumours driven by FGFR2 fusions depend on that signalling and shrink when it is blocked.","approvals":[{"region":"US","year":2021,"indication":"Previously treated unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement (accelerated approval)","note":"Indication withdrawn in 2024"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/infigratinib/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"}],"drug":[{"id":"futibatinib","kind":"drug","name":"Futibatinib","route":"/drugs/futibatinib/"},{"id":"pemigatinib","kind":"drug","name":"Pemigatinib","route":"/drugs/pemigatinib/"}],"company":[{"id":"bridgebio-oncology-therapeutics","kind":"company","name":"BridgeBio Oncology Therapeutics","route":"/companies/bridgebio-oncology-therapeutics/"},{"id":"helsinn","kind":"company","name":"Helsinn","route":"/companies/helsinn/"}]}}