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Futibatinib

FDA-approved product (tablet, oral), marketed as Lytgobi.

Registered studies
25
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Futibatinib
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cancer
  • Cholangiocarcinoma
  • Neoplasm

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Fibroblast growth factor receptor (fgfr) tyrosine kinase inhibitors
FDA pharmacologic class
Kinase Inhibitor FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA, E. coli and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA55.3% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli48.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae31.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis53.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

25registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.9 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.4 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.8 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.3 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Futibatinib with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, OPTIC Trial

    NCT07639528 · start 2027-12-10

    Registered record
    Registry ID
    NCT07639528
    Conditions
    Resectable Intrahepatic Cholangiocarcinoma
    Interventions
    Biospecimen Collection; Cisplatin; Computed Tomography; Durvalumab; Futibatinib; Gemcitabine; Magnetic Resonance Imaging
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2027-12-10
    Completion
    2031-12-10
    Enrolment
    44

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionResectable Intrahepatic Cholangiocarcinoma
    InterventionBiospecimen Collection; Cisplatin; Computed Tomography; Durvalumab +3 more
    PhasePhase 2
    Registry statusNot yet recruiting
  • Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

    NCT07594548 · start 2027-09-09

    Registered record
    Registry ID
    NCT07594548
    Conditions
    Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Esophageal Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Esophageal Adenocarcinoma; Locally Advanced Gastric Adenocarcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Metastatic Esophageal Adenocarcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Unresectable Esophageal Adenocarcinoma; Unresectable Gastric Adenocarcinoma; Unresectable Gastroesophageal Junction Carcinoma
    Interventions
    Biospecimen Collection; Computed Tomography; Futibatinib; Magnetic Resonance Imaging; Paclitaxel; Ramucirumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Not yet recruiting
    Start
    2027-09-09
    Completion
    2031-09-09
    Enrolment
    18

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionClinical Stage II Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 +12 more
    InterventionBiospecimen Collection; Computed Tomography; Futibatinib; Magnetic Resonance Imaging +2 more
    PhasePhase 1
    Registry statusNot yet recruiting
  • Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer

    NCT07745296 · start 2027-01-02

    Registered record
    Registry ID
    NCT07745296
    Conditions
    Biliary Tract Cancer (BTC)
    Interventions
    Futibatinib; Ivosidenib + Capecitabine; Zanidatamab + Capecitabine; Capecitabine (Xeloda)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Not yet recruiting
    Start
    2027-01-02
    Completion
    2033-07-02
    Enrolment
    990

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBiliary Tract Cancer (BTC)
    InterventionFutibatinib; Ivosidenib + Capecitabine; Zanidatamab + Capecitabine; Capecitabine (Xeloda)
    PhasePhase 3
    Registry statusNot yet recruiting
  • Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

    NCT07710885 · start 2026-06-24

    Registered record
    Registry ID
    NCT07710885
    Conditions
    Biliary Tract Cancer
    Interventions
    Futibatinib; Zimberelimab; Durvalumab; Pembrolizumab; Gemcitabine; Cisplatin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2026-06-24
    Completion
    2031-12-31
    Enrolment
    784

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBiliary Tract Cancer
    InterventionFutibatinib; Zimberelimab; Durvalumab; Pembrolizumab +2 more
    PhasePhase 3
    Registry statusRecruiting
  • Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities

    NCT06722183 · start 2025-12-16

    Registered record
    Registry ID
    NCT06722183
    Conditions
    Colorectal Cancer
    Interventions
    Futibatinib orally administered; Tislelizumab (i.v. 200mg)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-12-16
    Completion
    2028-03
    Enrolment
    33

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionColorectal Cancer
    InterventionFutibatinib orally administered; Tislelizumab (i.v. 200mg)
    PhasePhase 2
    Registry statusRecruiting
  • Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

    NCT06263153 · start 2024-12-30

    Registered record
    Registry ID
    NCT06263153
    Conditions
    Bladder Urothelial Carcinoma; Muscle Invasive Bladder Carcinoma; Stage II Bladder Cancer AJCC v8; Stage IIIA Bladder Cancer AJCC v8
    Interventions
    Biospecimen Collection; Computed Tomography; Durvalumab; Futibatinib; Magnetic Resonance Imaging; Radical Cystectomy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-12-30
    Completion
    2026-12-31
    Enrolment
    24

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBladder Urothelial Carcinoma; Muscle Invasive Bladder Carcinoma; Stage II Bladder Cancer AJCC v8; Stage IIIA Bladder Cancer AJCC v8
    InterventionBiospecimen Collection; Computed Tomography; Durvalumab; Futibatinib +2 more
    PhasePhase 2
    Registry statusRecruiting
  • Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

    NCT06506955 · start 2024-10-01

    Registered record
    Registry ID
    NCT06506955
    Conditions
    Advanced/Metastatic Cancer
    Interventions
    futibatinib; futibatinib, fulvestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Active not recruiting
    Start
    2024-10-01
    Completion
    2027-04-30
    Enrolment
    15

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced/Metastatic Cancer
    Interventionfutibatinib; futibatinib, fulvestrant
    PhasePhase 2 / Phase 3
    Registry statusActive not recruiting
  • Personalized Medicine for Advanced Biliary Cancer Patients

    NCT05615818 · start 2024-07-18

    Registered record
    Registry ID
    NCT05615818
    Conditions
    Biliary Tract Neoplasms
    Interventions
    Futibatinib; Ivosidenib; Zanidatamab; Trastuzumab; Neratinib; Encorafenib; Binimetinib; Niraparib; Cisplatin; Gemcitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-07-18
    Completion
    2028-06
    Enrolment
    800

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBiliary Tract Neoplasms
    InterventionFutibatinib; Ivosidenib; Zanidatamab; Trastuzumab +6 more
    PhasePhase 3
    Registry statusRecruiting
  • Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

    NCT05945823 · start 2023-07-13

    Registered record
    Registry ID
    NCT05945823
    Conditions
    Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer; Esophageal Adenocarcinoma; Esophageal Squamous Cell Cancer; Siewert Type 1 GEJ Cancer; Pancreatic Cancer
    Interventions
    Futibatinib; Pembrolizumab; Cisplatin; 5-FU; Oxaliplatin; Leucovorin; Levoleucovorin; Irinotecan
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2023-07-13
    Completion
    2027-01
    Enrolment
    53

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLocally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer; Esophageal Adenocarcinoma; Esophageal Squamous Cell Cancer; Siewert Type 1 GEJ Cancer +1 more
    InterventionFutibatinib; Pembrolizumab; Cisplatin; 5-FU +4 more
    PhasePhase 2
    Registry statusActive not recruiting
  • Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

    NCT05727176 · start 2023-07-05

    Registered record
    Registry ID
    NCT05727176
    Conditions
    Advanced Cholangiocarcinoma; FGFR2 Fusions; Gene Rearrangement
    Interventions
    TAS-120
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-07-05
    Completion
    2026-12
    Enrolment
    120

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced Cholangiocarcinoma; FGFR2 Fusions; Gene Rearrangement
    InterventionTAS-120
    PhasePhase 2
    Registry statusRecruiting
  • Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications

    NCT05827614 · start 2023-03-24

    Registered record
    Registry ID
    NCT05827614
    Conditions
    Triple Negative Breast Cancer (TNBC); High Grade Serous Ovarian Carcinoma; High Grade Endometrial Carcinoma; Anogenital Cancer; Head and Neck (HNSCC); Cutaneous Squamous Cell Carcinoma (CSCC); Cervical Squamous Cell Carcinoma; ER+ Breast Cancer; Leiomyosarcoma (LMS); Undifferentiated Pleomorphic Sarcoma (UPS); Pancreatic Cancer Metastatic; Small Cell Lung Cancer
    Interventions
    BBI-355; Erlotinib; Futibatinib; BBI-825
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2023-03-24
    Completion
    2026-03-17
    Enrolment
    85

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTriple Negative Breast Cancer (TNBC); High Grade Serous Ovarian Carcinoma; High Grade Endometrial Carcinoma; Anogenital Cancer +8 more
    InterventionBBI-355; Erlotinib; Futibatinib; BBI-825
    PhasePhase 1
    Registry statusTerminated
  • A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma

    NCT05036681 · start 2021-09-30

    Registered record
    Registry ID
    NCT05036681
    Conditions
    Metastatic Cancer; Endometrium Cancer; Endometrial Carcinoma
    Interventions
    Futibatinib; Pembrolizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-09-30
    Completion
    2025-05-06
    Enrolment
    9

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Cancer; Endometrium Cancer; Endometrial Carcinoma
    InterventionFutibatinib; Pembrolizumab
    PhasePhase 2
    Registry statusTerminated
  • Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer

    NCT04965818 · start 2021-09-20

    Registered record
    Registry ID
    NCT04965818
    Conditions
    Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations; Non-Small Cell Lung Cancer; KRAS Gene Mutation
    Interventions
    Futibatinib and Binimetinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2021-09-20
    Completion
    2023-09-21
    Enrolment
    38

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced or Metastatic Solid Tumors Irrespective of Gene Alterations; Non-Small Cell Lung Cancer; KRAS Gene Mutation
    InterventionFutibatinib and Binimetinib
    PhasePhase 1
    Registry statusTerminated
  • Futibatinib and Pembrolizumab for Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

    NCT04828486 · start 2021-08-17

    Registered record
    Registry ID
    NCT04828486
    Conditions
    Advanced Hepatocellular Carcinoma; BCLC Stage A Hepatocellular Carcinoma; BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; Metastatic Hepatocellular Carcinoma
    Interventions
    Futibatinib; Pembrolizumab; Quality-of-Life Assessment
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-08-17
    Completion
    2025-08-31
    Enrolment
    14

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced Hepatocellular Carcinoma; BCLC Stage A Hepatocellular Carcinoma; BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma +1 more
    InterventionFutibatinib; Pembrolizumab; Quality-of-Life Assessment
    PhasePhase 2
    Registry statusCompleted
  • AB122 Platform Study

    NCT04999761 · start 2021-06-01

    Registered record
    Registry ID
    NCT04999761
    Conditions
    Advanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Gastric Cancer; Alveolar Soft Part Sarcoma; Esophageal Cancer; Head and Neck Cancer; Biliary Tract Cancer
    Interventions
    AB122; AB122; TAS-116; TAS-120; TAS-115; TAS-102; Ramucirumab; TAS-102; Bevacizumab; Fluorouracil; Cisplatin; AB154; Fluorouracil; Carboplatin; Cisplatin; Carboplatin; nab-Paclitaxel; Cisplatin; Gemcitabine; nab-Paclitaxel; Gemcitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2021-06-01
    Completion
    2027-06
    Enrolment
    917

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer +5 more
    InterventionAB122; AB122; TAS-116; TAS-120 +17 more
    PhasePhase 1
    Registry statusRecruiting