Drugs / Futibatinib
last change Jun 2026 re-read 2 minutes ago

Futibatinib

also known as TAS-120 · Fgfr-in-1 · Lytgobi

Small molecule targets FGFR1, FGFR2 via inhibition

Developed for
cholangiocarcinoma · breast cancer · endometrial carcinoma · esophageal adenocarcinoma · gastroesophageal cancer · malignant pancreatic neoplasm · urothelial carcinoma · biliary tract cancer
+28 more · biliary tract neoplasm · cervical squamous cell carcinoma · childhood malignant neoplasm · colorectal cancer · esophageal squamous cell carcinoma · estrogen-receptor positive breast cancer · gastric adenocarcinoma · gastric cancer · gastroesophageal junction adenocarcinoma · head and neck squamous cell carcinoma · hematopoietic and lymphoid cell neoplasm · hepatocellular carcinoma · infiltrating bladder urothelial carcinoma · intrahepatic cholangiocarcinoma · leiomyosarcoma · metastatic malignant neoplasm · metastatic neoplasm · neoplasm · non-Hodgkin lymphoma · non-small cell lung carcinoma · ovarian serous adenocarcinoma · plasma cell myeloma · primary brain neoplasm · skin squamous cell carcinoma · small cell lung carcinoma · soft tissue sarcoma · triple-negative breast carcinoma · undifferentiated pleomorphic sarcoma
Investigated by
Taiho Oncology, Inc. · National Cancer Institute (NCI) · National Cancer Institute, France · Northwestern University · Accord Healthcare, Inc. · American Society of Clinical Oncology
+41 more · AstraZeneca · Bayer · Belgian Group of Digestive Oncology · Boehringer Ingelheim · Boundless Bio, Inc. · Bristol-Myers Squibb · Cancer Research UK · Cancer Research UK & UCL Cancer Trials Centre · EUCLID Clinical Trial Platform · Eli Lilly and Company · Fight Kids Cancer · Fondation ARC · French Alternative Energies and Atomic Energy Commission · French National Institute of Health and Medical Research · Gateway for Cancer Research · Genentech, Inc. · Gustave Roussy, Cancer Campus, Grand Paris · IQVIA Pty Ltd · Institut Bergonié · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Janssen, LP · M.D. Anderson Cancer Center · Mayo Clinic · Merck Institute for Therapeutic Research · Merck Sharp & Dohme LLC · National Comprehensive Cancer Network · Novartis · Pfizer · Pierre Fabre Laboratories · Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris · Plateforme labellisée Inca - Institut Bergonié, Bordeaux · Roche Pharma AG · Seattle Genetics (now a wholly owned subsidiary of Pfizer) · Servier · Taiho Pharmaceutical Co., Ltd. · Taisho Pharmaceutical Co., Ltd. · UNICANCER · Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler · Vall d'Hebron Institute of Oncology · Yuanquan Yang · Zymeworks BC Inc.

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved · conditional EU (EMA) Lytgobi 2023-07-04 europa.eu
Approved US (FDA) LYTGOBI 2022-09-30 fda.gov

Trials 23 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07594548 Sep 2027 → Sep 2030 expected esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Northwestern University Not yet recruiting No outcome recorded
Phase 1 NCT05827614 Mar 2023 → Mar 2026 cervical squamous cell carcinoma, endometrial carcinoma, estrogen-receptor positive breast cancer, head and neck squamous cell carcinoma +7 Boundless Bio, Inc. Terminated No outcome recorded
Phase 1 NCT04965818 Sep 2021 → Jun 2023 non-small cell lung carcinoma Taiho Oncology, Inc. Terminated No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT02813135 Aug 2016 → Feb 2031 expected childhood malignant neoplasm Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
Phase 1/2 NCT02052778 Jul 2014 → Oct 2020 breast cancer, cholangiocarcinoma, gastric cancer, primary brain neoplasm +1 Taiho Oncology, Inc. Completed No outcome recorded
Phase 212 trials
Phase 2 NCT07639528 Dec 2027 → Dec 2030 expected intrahepatic cholangiocarcinoma Northwestern University Not yet recruiting No outcome recorded
Phase 2 NCT06722183 Dec 2025 → Mar 2028 expected colorectal cancer Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Recruiting No outcome recorded
Phase 2 NCT06263153 Dec 2024 → Dec 2026 expected infiltrating bladder urothelial carcinoma Yuanquan Yang Recruiting No outcome recorded
Phase 2 NCT05945823 Jul 2023 → Jan 2026 overdue esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal cancer, malignant pancreatic neoplasm Taiho Oncology, Inc. Active not recruiting No outcome recorded
Phase 2 NCT05727176 Jul 2023 → Dec 2026 expected cholangiocarcinoma Taiho Oncology, Inc. Recruiting No outcome recorded
Phase 2 NCT05036681 Sep 2021 → Sep 2024 endometrial carcinoma, metastatic malignant neoplasm M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT04828486 Aug 2021 → Sep 2024 hepatocellular carcinoma Mayo Clinic Completed No outcome recorded
Phase 2 NCT04601857 Jan 2021 → Mar 2024 urothelial carcinoma Taiho Oncology, Inc. Terminated No outcome recorded
Phase 2 NCT04189445 Aug 2020 → Nov 2024 gastroesophageal cancer, hematopoietic and lymphoid cell neoplasm Taiho Oncology, Inc. Terminated No outcome recorded
Phase 2 NCT04024436 Jan 2020 → May 2023 breast cancer Taiho Oncology, Inc. Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06506955 Oct 2024 → Apr 2027 expected metastatic neoplasm Taiho Oncology, Inc. Enrolling by invitation No outcome recorded
Phase 34 trials
Phase 3 NCT07710885 Jun 2026 → Apr 2030 expected biliary tract cancer Taiho Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT05615818 Jul 2024 → Jun 2027 expected biliary tract neoplasm UNICANCER Recruiting No outcome recorded
Phase 3 NCT04093362 Jan 2021 → Apr 2024 cholangiocarcinoma Taiho Oncology, Inc. Terminated No outcome recorded
Phase 3 NCT03784014 Oct 2019 → Dec 2023 soft tissue sarcoma French National Institute of Health and Medical Research Completed No outcome recorded
Phase not stated1 trial
NCT04507503 cholangiocarcinoma Taiho Oncology, Inc. Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT04999761 Background Jun 2021 → May 2026 overdue alveolar soft part sarcoma, biliary tract cancer, colorectal cancer, esophageal cancer +4 Taiho Pharmaceutical Co., Ltd. Recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Futibatinib “An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements” NCT04507503
20

NCT05036681

NCT04093362

NCT02693535

NCT05827614

NCT02813135

NCT04189445

NCT06722183

NCT03767075

NCT04828486

NCT02052778

NCT07594548

NCT06506955

NCT05945823

NCT04601857

NCT06263153

NCT07639528

NCT04024436

NCT07710885

NCT05615818

NCT04965818

Known as Fgfr-in-1 ChEMBL registry synonym — accepted as the source's own label CHEMBL3701238
Known as Lytgobi ChEMBL registry synonym — accepted as the source's own label CHEMBL3701238
Known as TAS-120 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05727176
3

NCT04999761

NCT04507503

NCT03784014

Action Inhibit “Futibatinib is an oral, irreversible, highly selective fibroblast growth factor receptor (FGFR)1-4 inhibitor with potent preclinical activity against tumors harboring FGFR aberrations.” PMID 32622884 Jul 2020
Modality Small molecule CHEMBL3701238
Route Oral “The patients received oral futibatinib at a dose of 20 mg once daily in a continuous regimen.” PMID 36652354 Jan 2023
Target FGFR1 “Futibatinib, a next-generation, covalently binding FGFR1-4 inhibitor, has been shown to have both antitumor activity in patients with FGFR-altered tumors and strong preclinical...” PMID 36652354 Jan 2023