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There are no available data on the use of LYTGOBI in pregnant women. Advise pregnant women of the potential risk to fetus.","Geriatric use":"No overall differences in safety or effectiveness of LYTGOBI have been observed between patients 65 years of age and older and younger adult patients.","Paediatric use":"The safety and effectiveness of LYTGOBI have not been established in pediatric patients."},"seriousAdverseEvents":[{"effect":"Pyrexia","drugRate":"3.9%","severity":"serious"},{"effect":"Gastrointestinal hemorrhage","drugRate":"3.9%","severity":"serious"},{"effect":"Ascites","drugRate":"2.9%","severity":"serious"},{"effect":"Musculoskeletal pain","drugRate":"2.9%","severity":"serious"},{"effect":"Bile duct obstruction","drugRate":"2.9%","severity":"serious"},{"effect":"Retinal pigment epithelial detachment","drugRate":"7.8%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Taiho Oncology","patents":[{"applNo":"N214801","source":"FDA Orange Book","status":"Active","expires":"Feb 13, 2033","useCode":"U-3456","territory":"US","drugProduct":true,"patentNumber":"9108973","drugSubstance":true},{"applNo":"N214801","source":"FDA Orange Book","status":"Active","expires":"Nov 5, 2039","useCode":"","territory":"US","drugProduct":true,"patentNumber":"11833151","drugSubstance":false},{"applNo":"N214801","source":"FDA Orange Book","status":"Active","expires":"Mar 31, 2036","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10434103","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=futibatinib","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:42:02.672956+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:42:00.588878+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Futibatinib","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:42:09.931951+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:42:08.476706+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:42:02.746139+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=futibatinib","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:42:08.894603+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Fibroblast growth factor receptor inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:42:09.931875+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3701238/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:42:09.591549+00:00"}},"allNames":"lytgobi","offLabel":[],"synonyms":["futibatinib","lytgobi","TAS-120"],"timeline":[{"date":"2022-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from TAIHO ONCOLOGY to Taiho Oncology"},{"date":"2022-09-30","type":"positive","source":"DrugCentral","milestone":"FDA approval (Taiho Oncology)"},{"date":"2023-07-04","type":"positive","source":"DrugCentral","milestone":"EMA approval (Taiho Pharma Netherlands B.V.)"},{"date":"2027-09-30","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"},{"date":"2029-09-30","type":"negative","source":"FDA Orange Book","milestone":"ODE-410 exclusivity expires"},{"date":"2033-02-13","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 9108973 expires"},{"date":"2036-03-31","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 10434103 expires"}],"aiSummary":"Lytgobi (futibatinib) is a small molecule drug developed by Taiho Oncology, targeting fibroblast growth factor receptor 2 (FGFR2) in intrahepatic cholangiocarcinoma. It was FDA-approved in 2022 for this indication. Lytgobi is a patented medication with no generic manufacturers available. Key safety considerations include the potential for adverse effects such as diarrhea, nausea, and fatigue. Lytgobi's commercial status is patented, with Taiho Oncology as the current owner.","brandName":"Lytgobi","ecosystem":[{"indication":"Intrahepatic cholangiocarcinoma","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":"FGFR3","source":"DrugCentral","target":"Fibroblast growth factor receptor 3","protein":"Fibroblast growth factor receptor 3"},{"gene":"FGFR4","source":"DrugCentral","target":"Fibroblast growth factor receptor 4","protein":"Fibroblast growth factor receptor 4"},{"gene":"FGFR1","source":"DrugCentral","target":"Fibroblast growth factor receptor 1","protein":"Fibroblast growth factor receptor 1"},{"gene":"BTK","source":"DrugCentral","target":"Tyrosine-protein kinase BTK","protein":"Tyrosine-protein kinase BTK"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Lytgobi is a potent and selective inhibitor of FGFR2, with a high affinity for the ATP-binding site, thereby preventing the activation of downstream signaling pathways and inhibiting tumor growth."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Futibatinib","title":"Futibatinib","extract":"Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma. It is a kinase inhibitor. It is taken by mouth.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nOn 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Lytgobi, intended for the second-line treatment of locally advanced or metastatic cholangiocarcinoma characterized by fusion or rearrangements of fibroblast growth factor receptor (FGFR) 2. Futibatinib was approved for medical use in the European Union in July 2023."},"commercial":{"launchDate":"2022","_launchSource":"DrugCentral (FDA 2022-09-30, TAIHO ONCOLOGY)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5680","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=futibatinib","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=futibatinib","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Futibatinib","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 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