{"id":"infigratinib","rwe":[{"pmid":"41850040","year":"2026","title":"Phase III trial of infigratinib versus gemcitabine/cisplatin in adults with advanced cholangiocarcinoma with FGFR2 gene fusion or rearrangement: results and reflections on early termination of PROOF 301.","finding":"","journal":"ESMO open","studyType":"Clinical Study"},{"pmid":"41641077","year":"2026","title":"Inhibition of FGFR signaling with infigratinib improves linear bone growth in the female Aga2/+ mouse model of osteogenesis imperfecta.","finding":"","journal":"JBMR plus","studyType":"Clinical Study"},{"pmid":"41593746","year":"2026","title":"Response to Letter to the Editor for \"Infigratinib low dose therapy is an effective strategy to treat hypochondroplasia\".","finding":"","journal":"Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research","studyType":"Clinical Study"},{"pmid":"41582902","year":"2026","title":"Infigratinib is a weak inhibitor of the FGFR3-N540K mutant associated with hypochondroplasia.","finding":"","journal":"Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research","studyType":"Clinical Study"},{"pmid":"41567627","year":"2025","title":"Fibroblast growth factor receptor inhibitors in glioma: a narrative review of recent advances.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Fibroblast growth factor receptor 2","category":"target"},{"label":"FGFR2","category":"gene"},{"label":"FGFR1","category":"gene"},{"label":"FGFR3","category":"gene"},{"label":"L01EN03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion","category":"indication"},{"label":"Helsinn Hlthcare","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[],"specialPopulations":{"Lactation":"Advise not to breastfeed.","Pregnancy":"Advise pregnant women of the potential risk to fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively."}},"trials":[],"aliases":[],"company":"Helsinn Hlthcare","patents":[{"applNo":"N214622","source":"FDA Orange Book","status":"Active","expires":"Dec 11, 2034","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10278969","drugSubstance":false},{"applNo":"N214622","source":"FDA Orange Book","status":"Active","expires":"Aug 25, 2029","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8552002","drugSubstance":true},{"applNo":"N214622","source":"FDA Orange Book","status":"Active","expires":"Aug 6, 2028","useCode":"","territory":"US","drugProduct":false,"patentNumber":"9067896","drugSubstance":true},{"applNo":"N214622","source":"FDA Orange Book","status":"Active","expires":"Dec 11, 2034","useCode":"","territory":"US","drugProduct":true,"patentNumber":"11160804","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=INFIGRATINIB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:37:42.764840+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:37:40.877118+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Infigratinib","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:37:50.016080+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:37:48.679963+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=INFIGRATINIB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:37:48.975414+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Fibroblast growth factor receptor inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:37:50.016015+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1852688/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:37:49.684643+00:00"}},"allNames":"truseltiq","offLabel":[],"synonyms":["infigratinib","infigratinib phosphate","truseltiq","BGJ-398","NVP-BGJ398"],"timeline":[{"date":"2019-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from QED THERAP to Helsinn Hlthcare"},{"date":"2019-06-28","type":"positive","source":"DrugCentral","milestone":"FDA approval (Qed Therap)"},{"date":"2026-05-28","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"},{"date":"2028-05-28","type":"negative","source":"FDA Orange Book","milestone":"ODE-353 exclusivity expires"},{"date":"2028-08-06","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 9067896 expires"},{"date":"2029-08-25","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8552002 expires"}],"aiSummary":"Truseltiq (INFIGRATINIB) is a small molecule drug developed by QED Therapeutics and currently owned by Helsinn Healthcare. It targets fibroblast growth factor receptor 2 (FGFR2) and is approved by the FDA for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion. Truseltiq is a patented medication with no generic manufacturers available. The safety considerations for Truseltiq include its potential side effects, which may include hepatotoxicity and gastrointestinal disorders. Truseltiq was approved in 2019.","approvals":[{"date":"2019-06-28","orphan":true,"company":"QED THERAP","regulator":"FDA"}],"brandName":"Truseltiq","ecosystem":[{"indication":"Unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Fibroblast growth factor receptor 2","novelty":"Follow-on","targets":[{"gene":"FGFR2","source":"DrugCentral","target":"Fibroblast growth factor receptor 2","protein":"Fibroblast growth factor receptor 2"},{"gene":"FGFR1","source":"DrugCentral","target":"Fibroblast growth factor receptor 1","protein":"Fibroblast growth factor receptor 1"},{"gene":"FGFR3","source":"DrugCentral","target":"Fibroblast growth factor receptor 3","protein":"Fibroblast growth factor receptor 3"},{"gene":"SMO","source":"DrugCentral","target":"Smoothened homolog","protein":"Smoothened homolog"},{"gene":"FGFR4","source":"DrugCentral","target":"Fibroblast growth factor receptor 4","protein":"Fibroblast growth factor receptor 4"},{"gene":"KDR","source":"DrugCentral","target":"Vascular endothelial growth factor receptor 2","protein":"Vascular endothelial growth factor receptor 2"},{"gene":"LYN","source":"DrugCentral","target":"Tyrosine-protein kinase Lyn","protein":"Tyrosine-protein kinase Lyn"},{"gene":"KIT","source":"DrugCentral","target":"Mast/stem cell growth factor receptor Kit","protein":"Mast/stem cell growth factor receptor Kit"},{"gene":"YES1","source":"DrugCentral","target":"Tyrosine-protein kinase Yes","protein":"Tyrosine-protein kinase Yes"},{"gene":"FLT1","source":"DrugCentral","target":"Vascular endothelial growth factor receptor 1","protein":"Vascular endothelial growth factor receptor 1"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Truseltiq is a potent and selective inhibitor of FGFR2, which is a key driver of tumor growth in cholangiocarcinoma with FGFR2 fusion. By blocking FGFR2, Truseltiq inhibits the downstream signaling pathways that promote cell proliferation and survival, ultimately leading to tumor regression."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Infigratinib","title":"Infigratinib","extract":"Infigratinib is an kinase inhibitor in development for the treatment of achondroplasia and hypochondroplasia.","wiki_history":"== History ==\nThe US Food and Drug Administration (FDA) approved infigratinib based on evidence from one clinical trial (NCT02150967) of 108 participants with bile duct cancer (cholangiocarcinoma).  The CBGJ398X2204 trial was a multicenter open-label single-arm trial that enrolled 108 participants with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement as determined by local or central testing. The trials were conducted at 18 sites in the United States, Europe, and Asia. The trial enrolled adult participants with bile duct cancer who had been treated previously with chemotherapy for their advanced cancer and whose tumors had a certain type of abnormality in the FGFR2 gene. Participants received infigratinib once daily by mouth for 21 consecutive days followed by 7 days off therapy. This 28-day cycle was administered until disease progression or the side effects became too toxic. The trial measured the percentage of participants who achieved partial or complete shrinkage of their cancer and how long that shrinkage lasted (duration of response or DoR).\n\nInfigratinib has since been developed at a lower dose (0.25 mg/kg) for children with achondroplasia, a condition caused by variants in the FGFR3 gene. Preliminary Phase 2 results showed that children treated with infigratinib showed a mean change from baseline in annualized height velocity of +2.51 cm/yr at 12 months, with no serious adverse events.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nInfigratinib was designated an orphan drug by the FDA and the European Medicines Agency in 2021. It was approved for medical use under the FDA's accelerated approval program in May 2021. Infigratinib has since been withdrawn from commercialization due to the sponsor's difficulties distributing the drug and enrolling a confirmatory clinical trial."},"commercial":{"launchDate":"2019","_launchSource":"DrugCentral (FDA 2019-06-28, QED THERAP)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5459","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=INFIGRATINIB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=INFIGRATINIB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Infigratinib","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T13:57:47.542124","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:37:51.299121+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"erdafitinib","drugSlug":"erdafitinib","fdaApproval":"2019-04-12","patentExpiry":"Oct 18, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"pemigatinib","drugSlug":"pemigatinib","fdaApproval":"2020-04-17","patentExpiry":"May 3, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"futibatinib","drugSlug":"futibatinib","fdaApproval":"2022-09-30","patentExpiry":"Nov 5, 2039","patentStatus":"Patent protected","relationship":"same-class"}],"exclusivity":[{"code":"NCE","date":"May 28, 2026"},{"code":"ODE-353","date":"May 28, 2028"},{"code":"NCE","date":"May 28, 2026"},{"code":"ODE-353","date":"May 28, 2028"}],"genericName":"infigratinib","indications":{"approved":[{"name":"Unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion","source":"DrugCentral","snomedId":312104005,"regulator":"FDA","eligibility":{"age":"adults","stage":"previously treated, unresectable locally advanced or metastatic","biomarkers":"FGFR2 fusion or other rearrangement","prior treatment":"previously treated"}}],"offLabel":[],"pipeline":[]},"currentOwner":"Helsinn Hlthcare","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"erdafitinib","brandName":"erdafitinib","genericName":"erdafitinib","approvalYear":"2019","relationship":"same-class"},{"drugId":"pemigatinib","brandName":"pemigatinib","genericName":"pemigatinib","approvalYear":"2020","relationship":"same-class"},{"drugId":"futibatinib","brandName":"futibatinib","genericName":"futibatinib","approvalYear":"2022","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06164951","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia","status":"COMPLETED","sponsor":"QED Therapeutics, a BridgeBio company","startDate":"2023-11-10","conditions":["Achondroplasia"],"enrollment":114,"completionDate":"2025-12-18"},{"nctId":"NCT04233567","phase":"PHASE2","title":"Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations","status":"COMPLETED","sponsor":"Sameek Roychowdhury","startDate":"2020-01-16","conditions":["Advanced Malignant Solid Neoplasm","Cholangiocarcinoma","Metastatic Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm"],"enrollment":17,"completionDate":"2024-12-12"},{"nctId":"NCT07169279","phase":"PHASE2","title":"Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)","status":"RECRUITING","sponsor":"QED Therapeutics, a BridgeBio company","startDate":"2025-11-19","conditions":["Achondroplasia"],"enrollment":77,"completionDate":"2032-03"},{"nctId":"NCT04504331","phase":"PHASE1","title":"Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer","status":"TERMINATED","sponsor":"Jennifer Lee Caswell-Jin","startDate":"2020-10-13","conditions":["Breast Cancer","HER2-negative Breast Cancer","ER Positive Breast Cancer","PR-Positive Breast Cancer"],"enrollment":4,"completionDate":"2021-10-22"},{"nctId":"NCT02657486","phase":"NA","title":"BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2016-01-06","conditions":["Bladder Cancer","Non-Muscle-Invasive Urothelial Carcinoma"],"enrollment":4,"completionDate":"2026-02-04"},{"nctId":"NCT07393373","phase":"PHASE2","title":"Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia","status":"ENROLLING_BY_INVITATION","sponsor":"QED Therapeutics, a BridgeBio company","startDate":"2026-04-21","conditions":["Hypochondroplasia"],"enrollment":135,"completionDate":"2036-05-31"},{"nctId":"NCT06873035","phase":"PHASE2,PHASE3","title":"An Interventional Study of Infigratinib in Children With Hypochondroplasia","status":"ENROLLING_BY_INVITATION","sponsor":"QED Therapeutics, a BridgeBio company","startDate":"2025-04-22","conditions":["Hypochondroplasia"],"enrollment":24,"completionDate":"2027-01"},{"nctId":"NCT05145010","phase":"PHASE2","title":"Extension Study of Infigratinib in Children With Achondroplasia (ACH)","status":"ENROLLING_BY_INVITATION","sponsor":"QED Therapeutics, a BridgeBio company","startDate":"2021-12-06","conditions":["Achondroplasia"],"enrollment":300,"completionDate":"2032-02-01"},{"nctId":"NCT04424966","phase":"EARLY_PHASE1","title":"Infigratinib in Recurrent High-Grade Glioma Patients","status":"TERMINATED","sponsor":"Nader 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Alterations","status":"TERMINATED","sponsor":"QED Therapeutics, a BridgeBio company","startDate":"2020-03-11","conditions":["Upper Tract Urothelial Carcinomas","Urothelial Bladder Cancer"],"enrollment":39,"completionDate":"2023-02-28"},{"nctId":"NCT02159066","phase":"PHASE2","title":"LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-07-23","conditions":["Melanoma"],"enrollment":158,"completionDate":"2023-01-10"},{"nctId":"NCT05514912","phase":"PHASE2","title":"Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial","status":"WITHDRAWN","sponsor":"Emory University","startDate":"2024-03-01","conditions":["Resectable Intrahepatic Cholangiocarcinoma","Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8","Stage I Intrahepatic Cholangiocarcinoma AJCC v8","Stage II Intrahepatic Cholangiocarcinoma AJCC v8","Stage III Intrahepatic Cholangiocarcinoma AJCC v8"],"enrollment":0,"completionDate":"2027-06-23"},{"nctId":"NCT05510427","phase":"PHASE1","title":"Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification","status":"WITHDRAWN","sponsor":"M.D. Anderson Cancer Center","startDate":"2023-08-07","conditions":["Cholangiocarcinoma","Liver Cancer"],"enrollment":0,"completionDate":"2023-08-07"},{"nctId":"NCT02150967","phase":"PHASE2","title":"A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma","status":"TERMINATED","sponsor":"QED Therapeutics, a BridgeBio company","isPivotal":true,"startDate":"2014-07-23","conditions":["Advanced Cholangiocarcinoma","FGFR2 Gene 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Sonpavde","startDate":"2021-12-23","conditions":["Bladder Transitional Cell Carcinoma","Bladder Cancer","Fibroblast Growth Factor Receptor"],"enrollment":0,"completionDate":"2023-12"},{"nctId":"NCT05019794","phase":"PHASE2","title":"Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations","status":"UNKNOWN","sponsor":"LianBio LLC","startDate":"2020-05-13","conditions":["Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Solid Tumor"],"enrollment":80,"completionDate":"2023-12-30"},{"nctId":"NCT03510455","phase":"PHASE2","title":"BGJ398 for the Treatment of Tumor-Induced Osteomalacia","status":"TERMINATED","sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","startDate":"2019-02-27","conditions":["Tumor-Induced Osteomalacia","Oncogenic Osteomalacia"],"enrollment":4,"completionDate":"2020-05-04"},{"nctId":"NCT01928459","phase":"PHASE1","title":"Phase 1b Trial of BGJ398/BYL719 in Solid 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