Drugs / Infigratinib
last change Apr 2026 re-read 2 minutes ago

Infigratinib

also known as BGJ398 · Infigratinib Phosphate

Small molecule targets FGFR1, FGFR2, FGFR3 via inhibition

Developed for
achondroplasia · cholangiocarcinoma · cancer · gastric cancer · gastroesophageal junction adenocarcinoma · hypochondroplasia · bladder transitional cell carcinoma · central nervous system neoplasm
+25 more · cervical carcinoma · colon adenocarcinoma · estrogen-receptor positive breast cancer · gastrointestinal stromal tumor · glioblastoma · grade II glioma · hematopoietic and lymphoid cell neoplasm · Her2-receptor negative breast cancer · infiltrating bladder urothelial carcinoma · infiltrating renal pelvis/ureter urothelial carcinoma · intrahepatic cholangiocarcinoma · malignant glioma · melanoma · metastatic malignant neoplasm · metastatic neoplasm · nasopharyngeal carcinoma · non-invasive bladder urothelial carcinoma · Oncogenic osteomalacia · oropharynx squamous cell carcinoma · pancreatic ductal adenocarcinoma · progesterone-receptor positive breast cancer · rectum adenocarcinoma · renal pelvis/ureter urothelial carcinoma · squamous cell lung carcinoma · urinary bladder cancer
Investigated by
QED Therapeutics, a BridgeBio company · Helsinn Healthcare SA · Novartis Pharmaceuticals · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · LianBio LLC
+17 more · Memorial Sloan Kettering Cancer Center · Barrow Neurological Institute · Dana-Farber Cancer Institute · Emory University · Guru P. Sonpavde · Ivy Brain Tumor Center · Jennifer Lee Caswell-Jin · Labcorp Corporation of America Holdings, Inc · Nader Sanai · National Institute of Dental and Craniofacial Research (NIDCR) · Novartis · Pfizer · Roswell Park Cancer Institute · Sameek Roychowdhury · The University of Texas Health Science Center at San Antonio · University of Chicago · University of Pittsburgh

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TRUSELTIQ 2021-05-28 fda.gov

Trials 31 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04424966 Jul 2020 → Jan 2023 glioblastoma Nader Sanai Terminated No outcome recorded
Phase 17 trials
Phase 1 NCT05510427 Aug 2023 cholangiocarcinoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT04972253 Dec 2021 → Dec 2022 bladder transitional cell carcinoma Guru P. Sonpavde Withdrawn No outcome recorded
Phase 1 NCT04504331 Oct 2020 → Oct 2021 Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer Jennifer Lee Caswell-Jin Terminated No outcome recorded
Phase 1 NCT02312804 Jan 2015 cervical carcinoma The University of Texas Health Science Center at San Antonio Withdrawn No outcome recorded
Phase 1 NCT01928459 Oct 2013 → Aug 2016 cancer, metastatic neoplasm Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01697605 Oct 2012 → Feb 2019 Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01004224 Dec 2009 → Oct 2018 squamous cell lung carcinoma, urinary bladder cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT05222165 Oct 2021 → Dec 2022 central nervous system neoplasm, grade II glioma Helsinn Healthcare SA Withdrawn No outcome recorded
Phase 1/2 NCT04228042 Jul 2020 → Apr 2024 renal pelvis/ureter urothelial carcinoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 1/2 NCT02257541 Oct 2014 → Mar 2019 gastrointestinal stromal tumor Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/2 NCT02575508 ? → May 2020 colon adenocarcinoma, pancreatic ductal adenocarcinoma, rectum adenocarcinoma Roswell Park Cancer Institute Withdrawn No outcome recorded
Phase 214 trials
Phase 2 NCT07393373 Apr 2026 → May 2036 expected hypochondroplasia QED Therapeutics, a BridgeBio company Enrolling by invitation No outcome recorded
Phase 2 NCT07169279 Nov 2025 → Mar 2030 expected achondroplasia QED Therapeutics, a BridgeBio company Recruiting No outcome recorded
Phase 2 NCT05514912 Mar 2024 → Jun 2027 intrahepatic cholangiocarcinoma Emory University Withdrawn No outcome recorded
Phase 2 NCT06206278 Oct 2023 → May 2024 gastric cancer, gastroesophageal junction adenocarcinoma LianBio LLC Terminated No outcome recorded
Phase 2 NCT05145010 Dec 2021 → Dec 2031 expected achondroplasia QED Therapeutics, a BridgeBio company Enrolling by invitation No outcome recorded
Phase 2 NCT05019794 May 2020 → Dec 2022 gastric cancer, gastroesophageal junction adenocarcinoma LianBio LLC Unknown No outcome recorded
Phase 2 NCT04265651 Mar 2020 → Oct 2024 achondroplasia QED Therapeutics, a BridgeBio company Completed No outcome recorded
Phase 2 NCT04233567 Jan 2020 → Dec 2023 cholangiocarcinoma, metastatic malignant neoplasm Sameek Roychowdhury Completed No outcome recorded
Phase 2 NCT03510455 Feb 2019 → Feb 2020 Oncogenic osteomalacia National Institute of Dental and Craniofacial Research (NIDCR) Terminated No outcome recorded
Phase 2 NCT02706691 Jun 2018 → Feb 2019 human papilloma virus infection, nasopharyngeal carcinoma, oropharynx squamous cell carcinoma University of Chicago Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06873035 Apr 2025 → Jan 2027 expected hypochondroplasia QED Therapeutics, a BridgeBio company Enrolling by invitation No outcome recorded
Phase 33 trials
Phase 3 NCT06164951 Nov 2023 → Dec 2025 achondroplasia QED Therapeutics, a BridgeBio company Completed No outcome recorded
Phase 3 NCT04197986 Mar 2020 → Feb 2023 infiltrating bladder urothelial carcinoma, infiltrating renal pelvis/ureter urothelial carcinoma QED Therapeutics, a BridgeBio company Terminated No outcome recorded
Phase 3 NCT03773302 Dec 2019 → Mar 2023 cholangiocarcinoma QED Therapeutics, a BridgeBio company Terminated No outcome recorded
Phase not applicable1 trial
NCT02657486 Jan 2016 → Feb 2026 non-invasive bladder urothelial carcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

FieldValueCited text
Known as infigratinib “This phase IIa trial studies how well the experimental drug, BGJ398 (infigratinib), works in treating patients with fibroblast growth factor receptor (FGFR) 1-3 translocated,...” NCT02706691
18

Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre,...” PMID 34358484 Aug 2021

NCT06206278

NCT04424966

NCT06873035

NCT04265651

NCT07169279

NCT05145010

NCT04197986

NCT05510427

NCT07393373

NCT05222165

NCT05019794

NCT04228042

NCT05514912

NCT04504331

NCT04233567

NCT06164951

NCT04972253

Known as BGJ398 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01697605
13

NCT03510455

NCT02706691

NCT03773302

NCT01928459

NCT02657486

NCT02312804

NCT02159066

NCT02257541

NCT02150967

NCT01975701

NCT01004224

NCT02160041

NCT02575508

Known as Infigratinib Phosphate “Drug: Infigratinib PhosphateNCT05514912
Action Inhibit “a Pan FGF-R Kinase Inhibitor” NCT01004224
Modality Small molecule “Infigratinib is an oral FGFR 1-3 kinase inhibitor.” PMID 32580579 Jun 2020
Route Oral Oral BGJ398” NCT01004224
Target FGFR2 “Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.” NCT03773302