FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersOther Diseases+ [4]

Active Indication

FGFR2 fusion or rearranged CholangiocarcinomaIntrahepatic CholangiocarcinomaBiliary Tract Neoplasms+ [18]

Inactive Indication

Hematologic NeoplasmsKRAS Mutant Pancreatic CancerMetastatic breast cancer+ [2]

Originator Organization

Taiho Pharmaceutical Co., Ltd.

Active Organization

Taiho Oncology, Inc.

Taiho Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Sep 2022),

Intrahepatic Cholangiocarcinoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union)

Structure/Sequence

Molecular FormulaC22H22N6O3

InChIKeyKEIPNCCJPRMIAX-HNNXBMFYSA-N

CAS Registry1448169-71-8

Clinical Trials associated with Futibatinib

NCT06722183

/ Not yet recruitingPhase 2

FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities

The FUTURE trial is a prospective, multicentre, exploratory, open-label phase II platform trial. Its goal is to evaluate the efficacy, feasibility and safety of futibatinib combined with immunotherapeutic, targeted or chemotherapeutic agents in colorectal and other solid tumors and to additionally identify biomarkers that correlate with clinical outcome.

Start Date01 Jun 2025

Sponsor / Collaborator-

NCT06263153

/ RecruitingPhase 2IIT

A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy

This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.

Start Date30 Dec 2024

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+1]

CTIS2024-512217-40-00

/ RecruitingPhase 2/3

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study - TAS-120-404

Start Date21 Oct 2024

Sponsor / Collaborator

Taiho Oncology, Inc.

100 Clinical Results associated with Futibatinib

100 Translational Medicine associated with Futibatinib

100 Patents (Medical) associated with Futibatinib

138

Literatures (Medical) associated with Futibatinib

01 Nov 2025·TRENDS IN PHARMACOLOGICAL SCIENCES

Next-generation isoform-selective fibroblast growth factor receptor inhibitors

Review

Author: Chen, Lingfeng

Dysregulated fibroblast growth factor receptor (FGFR) signaling - driven by amplifications, mutations, or fusions - represents a clinically validated oncogenic driver across diverse malignancies. Pan-FGFR-selective inhibitors (erdafitinib, pemigatinib, and futibatinib) have been developed in clinical practice. However, their therapeutic efficacy is substantially limited by inevitable on-target resistance mutations and toxicities via FGFR1/4 inhibition. Next-generation FGFR isoform-selective small-molecule inhibitors are emerging and represent active research frontiers. FGFR2-selective inhibitor lirafugratinib, FGFR3-selective inhibitors LOXO-435 and TYRA-300, FGFR2/3-selective inhibitor ABSK061, and FGFR4-selective inhibitors are in clinical development. Additionally, novel isoform-selective FGFR-targeting degraders, FGFR2b/FGFR3-selective antibodies, and de novo-designed 'c' isoform-selective proteins provide novel treatment strategies. This review provides an overview of the current FGFR-targeted therapeutics and limitations and evaluates next-generation inhibitor development to guide future research.

01 Oct 2025·Clinical Journal of Gastroenterology

A case of FGFR2 fusion-positive pancreatic head tumor with difficult differential diagnosis between cholangiocarcinoma and pancreatic ductal adenocarcinoma

Article

Author: Masamune, Atsushi ; Kume, Kiyoshi ; Kano, Taku ; Furukawa, Toru ; Mizuma, Masamichi ; Unno, Michiaki ; Aoki, Shuichi ; Iseki, Masahiro ; Kamei, Takashi ; Murakami, Keigo

FGFR2 fusions and rearrangements are genetic abnormalities commonly observed in intrahepatic cholangiocarcinoma. A 42-year-old woman with a history of breast cancer presented to our hospital with jaundice. The patient was clinically diagnosed with distal cholangiocarcinoma (DCCA), and underwent pancreaticoduodenectomy. The tumor extensively invaded the pancreatic head, and intraductal spread was found in a branch of the pancreatic duct. Therefore, the patient was postoperatively diagnosed with pancreatic ductal adenocarcinoma (PDAC). Multiple lung metastases appeared 51 months after surgical resection. Partial lung resection confirmed histologically that the lung metastasis originated from PDAC. Furthermore, comprehensive genomic profiling (CGP) of lung resection specimens revealed FGFR2-SYCP1 fusion. However, common genetic alterations in PDAC, such as KRAS, SMAD4, TP53, and CDKN2A, were not detected in CGP. A re-evaluation of the resected pancreatic tissue showed that the histological features were possible for DCCA; however, it was difficult to make a conclusive diagnosis. Based on CGP analysis, the patient is currently receiving futibatinib, and the lung metastatic lesions have shrunk or partly disappeared. CGP can assist in selecting an appropriate therapeutic strategy when histological differentiation between DCCA and PDAC is challenging.

01 Sep 2025·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY

Adopted green spectrophotometric determination of futibatinib based on diazo coupling with 1-naphthol and assisted computational calculations

Author: Abdelazim, Ahmed H. ; Alaqel, Saleh l. ; Abduljabbar, Maram H. ; Alnemari, Reem M. ; Almalki, Atiah H. ; Alqahtani, Arwa S.

Futibatinib, a potent fibroblast growth factor receptor inhibitor, received US approval on Sept. 30, 2022, for treating breast, esophageal, and lung cancers by reducing cell viability.A new spectrophotometric method has been developed to accurately quantify this drug with the use of computational tools and matching environmentally friendly (green) principles. 1-Naphthol was found to be the best reagent for diazo-coupling of futibatinib based on the d. functional theory calculationsThe exptl. process involves diazo coupling futibatinib with sodium nitrite to produce a diazonium ion, which then interacts with 1-Naphthol to develop a red-colored chromogen complex.At 514 nm, the resultant complex displays defined measurable quant. absorption peaks.A number of elements that affect the diazotization were researched in order to optimize the process.The method exhibited excellent linearity within the range of 1-12 μg/mL (r2 = 0.9996), with limits of detection and quantification at 0.10 μg/mL and 0.30 μg/mL, resp.It also demonstrated high accuracy (99.32 %) and precision (%RSD < 1).The proposed method has a greener profile, scoring 0.69 compared to 0.48 for previously reported UPLC-MS/MS methods, offering reduced waste, shorter anal. times, and lower energy consumption.Addnl., it is more cost-effective and environmentally sustainable, making it a viable choice for both pure and pharmaceutical applications.

News (Medical) associated with Futibatinib

27 Jun 2025

·www.prnewswire.com

TransThera Publishes Translational Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Annals of Oncology

NANJING, China and GAITHERSBURG, Md., June 27, 2025 /PRNewswire/ -- TransThera Sciences Inc. ("TransThera") announced that the translational studies of tinengotinib in CCA with acquired resistance to FGFR inhibitors were published in Annals of Oncology (IF 56.7). Dr. Peng Peng, Vice President at TransThera, serves as the co-first author. CCA is an aggressive bile duct cancer often driven by FGFR2 fusion and rearrangement, which are targetable with inhibitors like pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this paper, multimodal analyses led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. Novel FGFR inhibitors should be small, high-affinity, and capable of binding to active form of FGFR. The article discloses for the first time the co-crystal structure of tinengotinib with the FGFR2 kinase domain of its unique binding mode, in addition to kinetic studies to illustrate its higher affinity compared to first-generation FGFR inhibitors, in vitro and in vivo activities against clinically acquired FGFR2 resistance mutations, as well as a case report to demonstrate its clinical efficacy. These data demonstrated that tinengotinib is a second-generation FGFR inhibitor meeting all the aforementioned criteria. Dr. Lipika Goyal, the Director of Gastrointestinal Oncology at the Stanford Cancer Center, who is the principal investigator of the study and correspondence author of the paper, stated, "The study represents a comprehensive analysis of acquired resistance to FGFR inhibitors using circulating tumor DNA, biopsy, rapid autopsy, pharmacokinetic, and in vitro and in vivo data, It represents the largest collection of primary patient data on acquired FGFR resistance, with analysis of nearly 500 clinical samples. Research in rare cancers like CCA relies on the collective efforts of numerous teams working together, and we highly appreciated the translational studies of tinengotinib by TransThera, which validated the principles of developing next-generation FGFR inhibitors highlighted in this publication. We believe this study will be a substantial contribution to the field that will advance our understanding of acquired resistance to FGFR inhibitors." "We are delighted that TransThera's discovery be part of the fundamental research in the field of overcoming FGFR refractory. Currently tinengotnib is undergoing a pivotal phase 3 study globally and we hope to bring novel treatment option to CCA patients", commented by Dr. Peng from TransThera. About Tinengotinib Tinengotinib is an internally discovered, global phase III multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation(ODD) and Fast Track Designation(FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory and cardiometabolic diseases. Further aided by in-depth study of translational medicine and drug design, TransThera aims to develop first-in-class or best-in-class drug candidates strategically positioned to meet urgent clinical needs on a global scale. For more information, please visit Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugFast TrackPhase 3Breakthrough Therapy

23 Apr 2025

·www.prnewswire.com

Taiho Oncology to Share Data in Five Presentations, Including Two Oral Presentations, at the 2025 American Society of Clinical Oncology Annual Meeting

Two oral presentations of phase 2 study findings from novel treatment options: an all-oral decitabine-cedazuridine combination for AML and zipalertinib for NSCLC that harbors exon 20 insertion mutations Additional presentations to include real-world data on the safety and effectiveness of two approved regimens: trifluridine-tipiracil paired with bevacizumab for metastatic colorectal cancer and futibatinib for cholangiocarcinoma PRINCETON, N.J., April 23, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced today that it will present new data from five studies, including two oral presentations, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 30 through June 3 at McCormick Place in Chicago. The oral presentations will feature data regarding ASTX727 (oral decitabine-cedazuridine), an agent approved for myelodysplastic syndromes (MDS), paired with venetoclax for the treatment of acute myeloid leukemia (AML) and the novel investigational drug candidate zipalertinib for the treatment of non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The company will also share data on three real-world studies of two FDA-approved therapies: trifluridine and tipiracil paired with bevacizumab for the later-line treatment of adult patients with metastatic colorectal cancer and futibatinib for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. "ASCO provides an invaluable opportunity to bring together the leading minds in oncology and discuss emerging new therapies and our understanding of real-world outcomes of existing therapies," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "Our data at ASCO will continue to demonstrate our unwavering commitment to meaningful innovation that can potentially improve the lives of patients with cancer, their families and their caregivers." Details about these presentations can be found below: Oral Presentations Title: Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab Abstract Number: 8503 Session Name: Lung Cancer – Non-Small Cell Metastatic Session Type: Oral Abstract Session Session Date: June 1, 2025 Presentation Time: 8 a.m. – 11 a.m. CDT Location: Arie Crown Theater | Live Stream Presenter: Helena A. Yu, MD, Memorial Sloan Kettering Cancer Center Title: An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a Phase 2 cohort of 101 pts Abstract Number: 6504 Session Name: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Session Type: Oral Abstract Session Session Date: June 2, 2025 Presentation Time: 3 p.m. – 6 p.m. CDT Location: S100a | Live Stream Presenter: Amer Zeidan, MBBS, Yale Cancer Center Poster Presentation Title: Real-world treatment patterns and outcomes with trifluridine/tipiracil monotherapy or in combination with bevacizumab in metastatic colorectal cancer Abstract Number: 3580 Session Name: Gastrointestinal Cancer—Colorectal and Anal Session Type: Poster Presentation Session Date: May 31, 2025 Presentation Time: 9 a.m. – 12 p.m. CDT Location: Hall A - Posters and Exhibits | On Demand Presenter: Donald Richards, MD, PhD, of Texas Oncology Online Abstracts Title: Real-world Clinical Outcomes of Patients with Metastatic Colorectal Cancer (mCRC) Treated with Trifluridine-Tipiracil + Bevacizumab by Performance Status Abstract Number: E15606 Session Type: Publication Only Publication Date: May 22, 2025 Publication Time: 5 p.m. EDT Lead Author: Maliha Nusrat, MD, MS, Memorial Sloan Kettering Cancer Center Title: Real-World patient characteristics and treatment patterns among cholangiocarcinoma patients treated with FGFR inhibitors Abstract Number: E16262 Session Type: Publication Only Publication Date: May 22, 2025 Publication Time: 5 p.m. EDT Lead Author: Amit Mahipal, MD, University Hospitals Seidman Cancer Center and Case Comprehensive Cancer Center About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. Taiho Oncology Contact: Leigh Labrie (609) 664-9878 [email protected] SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2ASCODrug ApprovalClinical Result

28 Mar 2025

·www.fiercepharma.com

Fierce Pharma Asia—Novo's triple G obesity bet; Merck's latest China deal; Hengrui, Elevar's 2nd FDA snub

Novo Nordisk's China obesity deal, Merck's cardiovascular licensing deal, and an FDA rejection for Hengrui and Elevar's PD-1 combo made our news this week. Novo Nordisk snapped up an obesity asset from China's United Laboratories in a deal worth up to $2 billion. Merck & Co. got a lipoprotein(a) inhibitor from Jiangsu Hengrui Pharma for cardiovascular disease. Hengrui and Elevar Therapeutics' PD-1 liver cancer combination was again tripped up by manufacturing at the FDA.1. Novo Nordisk pens $2B deal for triple G agonist tied to 15% weight loss at 12 weeksNovo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion. The candidate, coded UBT251, would be a direct competitor to Eli Lilly’s retatrutide. In a phase 1b trial, weekly UBT251 at the highest subcutaneous dose of 6 mg led to an average 15.1% weight loss from baseline after 12 weeks.2. Merck & Co. pens $200M upfront deal for Hengrui's midstage heart disease medIn another China deal potentially worth up to $2 billion, Merck & Co. is paying $200 million upfront for a phase 2 lipoprotein(a) inhibitor from Hengrui Pharma. Elevated Lp(a) in the blood, as a risk factor for cardiovascular disease, has become an increasingly popular target. Lilly has a clinical candidate called muvalaplin, and AstraZeneca last year licensed a preclinical one from China’s CSPC Pharma.3. FDA rejects Hengrui, Elevar's PD-1 cancer drug combination—againIn a piece of bad news for Hengrui, the FDA has once again rejected its Elevar Therapeutics-partnered combination of the PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib. Like the first rejection last year, the FDA this time also raised problems with Hengrui’s camrelizumab manufacturing facility in China.4. AbbVie takes Genmab to court, accusing partner of being 'willfully blind' to ADC trade secret theftAbbVie has sued Genmab over the Danish company’s $1.8 billion acquisition of Sino-American biotech ProfoundBio last year. The Illinois pharma alleged that Genmab was “intentionally and willfully blind” to Profound’s alleged theft of its antibody-drug conjugate trade secrets. Genmab said it “categorically refutes allegations and will vigorously defend the company.”5. J&J combo signals new era in EGFR lung cancer with survival win against AstraZeneca's TagrissoJohnson & Johnson’s Rybrevant and its Yuhan-partnered Lazcluze significantly reduced the risk of death by 25% versus AstraZeneca’s Tagrisso in first-line EGFR-mutated non-small cell lung cancer, according to a high-stakes readout from the phase 3 Mariposa trial. J&J believes the overall survival win sets the combo up to be the new standard of care. But the high-maintenance nature of the regimen poses a challenge.6. Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO surveyTrump again threatens tariffs on pharmaceuticals in 'not too distant' futurePresident Donald Trump said his administration will announce tariffs on pharmaceuticals “in the not too distant” future. But in a recent survey conducted by the Biotechnology Innovation Organization, a large proportion of biopharma companies polled said tariffs on EU, Canada or China will drive up manufacturing costs. Many respondents also fear that tariffs could disrupt R&D and regulatory plans.7. FDA calls out 'particularly concerning' claims on HCP site for Taiho's LytgobiThe FDA has taken issue with Taiho Oncology’s doctor-facing web page for the cholangiocarcinoma drug Lytgobi. The agency raised concerns that some descriptions of the drug’s overall survival and progression-free survival data from a single-arm phase 2 study were misleading. The agency is giving the firm 15 working days to submit a written response.8. Eisai lays out road map to blockbuster sales projections for Leqembi's 'milestone' 2027 year9. Contractors WuXi Bio, WuXi XDC eye continued growth after logging solid performances in 202410. Gavi terminates COVID vaccine deal with Clover, demands $224M repayment11. Ascletis slashes funding for former core programs in pivot to obesity12. ImmuneOnco axes CD47 bispecific as pipeline prioritization pressures hit Chinese biotech13. India's Aspen Biopharma Labs hit with FDA warning letter citing infrastructure, contamination and records problems14. Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO15. Bharat Biotech enters cell and gene therapy market with $75M production investment: reports16. Bayer gains Puhe’s cancer drug candidate in another China deal (release)17. Kaken agrees to $180M deal to develop Alumis' lead TYK2 inhibitor in Japan

VaccinePhase 2Phase 1Clinical ResultPhase 3

100 Deals associated with Futibatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11725	-	-	DB15149

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
FGFR2 fusion or rearranged Cholangiocarcinoma	Japan	Taiho Pharmaceutical Co., Ltd.	26 Jun 2023
Intrahepatic Cholangiocarcinoma	United States	Taiho Oncology, Inc.	30 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Biliary Tract Neoplasms	NDA/BLA	Japan	Taiho Pharmaceutical Co., Ltd.	30 Jan 2022
Neoplasm Metastasis	Phase 3	United States	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	France	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	South Korea	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	Spain	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	United Kingdom	Taiho Oncology, Inc.	01 Oct 2024
Adenocarcinoma of Esophagus	Phase 2	United States	Taiho Oncology, Inc.	13 Jul 2023
Adenocarcinoma of Esophagus	Phase 2	France	Taiho Oncology, Inc.	13 Jul 2023
Adenocarcinoma of Esophagus	Phase 2	Germany	Taiho Oncology, Inc.	13 Jul 2023
Adenocarcinoma of Esophagus	Phase 2	Spain	Taiho Oncology, Inc.	13 Jul 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04828486 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	14	Quality-of-Life Assessment+Futibatinib+Pembrolizumab	mnpiqzriqr = sigvzohcnb ssmbcwzqro (xpkngqhuzp, yoiqucxqbh - fixggksyup) View more	-	29 Oct 2025
NCT02813135 (AcSé-ESMART, ESMO2025)	Phase 1/2	FGFR mutation-related tumors FGFR alterations	20	Futibatinib (12-15 mg/m/day)	dvwsamxknu(vkqvjkzexw) = No dose-limiting toxicity occurred in 15 evaluable patients during cycle 1 (4 patients are pending for evaluation) yxxpqhjxck (tjaxfvowwm ) View more	Positive	17 Oct 2025
NCT05036681 (CTgov)	Phase 2	Neoplasm Metastasis \| Metastatic endometrial cancer	9	Futibatinib+Pembrolizumab	futxykvqlb = yuwwhcpchx syrqvfhdra (mpqiuyherh, dpizoambgq - zzbwlwrksk) View more	-	17 Sep 2025
NCT04093362 (FOENIX-CCA3, CTgov)	Phase 3	FGFR2 fusion or rearranged Cholangiocarcinoma	10	Futibatinib	skauqiwjfz = jltpaokjvd zsisxikskb (limjytyicv, hyiglvhiax - hsncjmufix) View more	-	07 Feb 2025
NCT04999761 (ASCO_GI2025) Manual	Phase 1	Metastatic Esophageal Carcinoma First line	43	Zimberelimab + Futibatinib + cisplatin + fluorouracil	hjhbxheyfe(vdotdudhhe) = DLTs were evaluated in the first three pts, and none were reported. rghpklnhqf (gmvdexofgr )	Positive	23 Jan 2025
Phase 1b study of futibatinib plus pembrolizumab (ASCO_GI2025)	Phase 1	Esophageal Carcinoma CD3+ \| CD4 \| CD8+ ... View more	18	Futibatinib + Pembrolizumab	miapkdrnhu(warywgozvl) = 22.2% llfasybccd (vnlefasasa ) View more	Positive	23 Jan 2025
NCT04601857 (ESMO2024) Manual	Phase 2	Transitional Cell Carcinoma First line FGFR alteration	43	Futibatinib 20 mg PO QD Pembrolizumabzumab 200 mg IV Q3W	vxhcoirsxg(nudusugwdi) = kuytuggqcd caeremubjq (yqynxqcoex, 23 - 72) View more	Positive	15 Sep 2024
NCT04601857 (ESMO2024) Manual	Phase 2	Transitional Cell Carcinoma First line FGFR alteration	43	Futibatinib 20 mg PO QD+PembrolizumabPembrolizumab 200 mg IV Q3W (without FGFR3 mutations or FGFR1–4 fusion/rearrangements)	vxhcoirsxg(nudusugwdi) = fmxpadyppz caeremubjq (yqynxqcoex, 14 - 52) View more	Positive	15 Sep 2024
NCT02052778 (FOENIX-CCA2, Pubmed \| Future Oncol) Manual	Phase 2	Advanced Bile Duct Carcinoma FGFR2 Fusion	-	Futibatinib	bsuclcfbza(iyfxckscpl) = nsbkvtnqcy ykzbixsdyq (iqntnsyrfl ) View more	Positive	17 Jun 2024
JPRN-jRCT2080224975 (ASCO2024) Manual	Phase 1	Esophageal Carcinoma	-	Futibatinib 2Pembrolizumabembrolizumab 200mg/q3w with chemotherapy	xhwhfrgybu(usjfqmpows) = tgraobykvz kaykfxgzbu (yjvllywshs, 43.4 - 87.4) View more	Positive	24 May 2024
JPRN-jRCT2080224975 (ASCO2024) Manual	Phase 1	Esophageal Carcinoma	-	Futibatinib 20Pembrolizumabmbrolizumab 200mg/q3w without chemotherapy	xhwhfrgybu(usjfqmpows) = lfxujcfvjm kaykfxgzbu (yjvllywshs, 26.3 - 60.6) View more	Positive	24 May 2024
JPRN-jRCT2080224975 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Esophageal Carcinoma	92	Futibatinib + pembrolizumab (ICI naïve)	pmufevtlim(ngvxcxncpv) = tmxnszqaek pppvktnohm (pjeazixsad ) View more	Positive	23 Oct 2023
JPRN-jRCT2080224975 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Esophageal Carcinoma	92	Futibatinib + pembrolizumab (ICI refractory)	pmufevtlim(ngvxcxncpv) = nxbfcmuetc pppvktnohm (pjeazixsad ) View more	Positive	23 Oct 2023

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