Skip to content

Erdafitinib

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

Registered studies
43
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Bladder tumor
  • Cancer
  • Neoplasm
  • Urinary bladder cancer
  • Urothelial carcinoma

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 M. tuberculosis and MRSA. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA54.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli37.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae26.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis46.0% 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

43registered 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)

-7.7 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.1 kcal/mol

0better fit →-12

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

-7.9 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.5 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 Erdafitinib 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.

  • A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

    NCT06919965 · start 2025-09-10

    Registered record
    Registry ID
    NCT06919965
    Conditions
    Non-Muscle Invasive Bladder Neoplasms
    Interventions
    TAR-210; Mitomycin C; Gemcitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2025-09-10
    Completion
    2032-03-16
    Enrolment
    220

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

    ConditionNon-Muscle Invasive Bladder Neoplasms
    InterventionTAR-210; Mitomycin C; Gemcitabine
    PhasePhase 3
    Registry statusRecruiting
  • Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

    NCT06692491 · start 2025-01-01

    Registered record
    Registry ID
    NCT06692491
    Conditions
    Rare Tumour
    Interventions
    Albumin-Bound Paclitaxel; Epirubicin; Gemcitabine; Vinorelbine; Cisplatin; Irinotecan; Fluorouracil; Nivolumab; Pembrolizumab; Durvalumab; Atezolizumab; Sintilimab; Tislelizumab; Camrelizumab; Toripalimab; Serplulimab; Adebrelimab; Envafolimab; Osimertinib; Alectinib; Vemurafenib; Pamiparib; Pyrotinib; Imatinib; Palbociclib; Savolitinib; Entrectinib; Other
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2025-01-01
    Completion
    2029-12-31
    Enrolment
    200

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

    ConditionRare Tumour
    InterventionAlbumin-Bound Paclitaxel; Epirubicin; Gemcitabine; Vinorelbine +24 more
    PhasePhase 2
    Registry statusNot yet recruiting
  • Drug Screening Using IMD in Bladder Cancer

    NCT06204614 · start 2024-06-14

    Registered record
    Registry ID
    NCT06204614
    Conditions
    Muscle Invasive Bladder Urothelial Carcinoma
    Interventions
    Implantable Micro-Device; Methotrexate; Carboplatin; Avelumab; Paclitaxel; Vinblastine; Gemcitabine/Cisplatin I; Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab; Gemcitabine/Cisplatin II; Cisplatin; Nivolumab; Pembrolizumab; Gemcitabine/Carboplatin; Methotrexate/Vinblastine/Doxorubicin/Cisplatin; Gemcitabine/Cisplatin/Nivolumab; Erdafitinib; Paclitaxel/Docetaxel/Ifosfamide; Gemcitabine; Gemcitabine/Carboplatin/Nivolumab; Enfortumab; Sacituzumab
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Enrolling by invitation
    Start
    2024-06-14
    Completion
    2028-08-01
    Enrolment
    18

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

    ConditionMuscle Invasive Bladder Urothelial Carcinoma
    InterventionImplantable Micro-Device; Methotrexate; Carboplatin; Avelumab +17 more
    PhaseEarly phase 1
    Registry statusEnrolling by invitation
  • A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

    NCT06319820 · start 2024-04-18

    Registered record
    Registry ID
    NCT06319820
    Conditions
    Non-Muscle Invasive Bladder Neoplasms
    Interventions
    TAR-210; Gemcitabine; MMC
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-04-18
    Completion
    2032-12-31
    Enrolment
    641

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

    ConditionNon-Muscle Invasive Bladder Neoplasms
    InterventionTAR-210; Gemcitabine; MMC
    PhasePhase 3
    Registry statusRecruiting
  • Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment

    NCT05859334 · start 2024-01-04

    Registered record
    Registry ID
    NCT05859334
    Conditions
    Recurrent Glioma; Recurrent WHO Grade 2 Glioma; Recurrent WHO Grade 3 Glioma; Recurrent WHO Grade 4 Glioma
    Interventions
    Biospecimen Collection; Erdafitinib; Magnetic Resonance Imaging; Optical Coherence Tomography
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-01-04
    Completion
    2026-10-23
    Enrolment
    30

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

    ConditionRecurrent Glioma; Recurrent WHO Grade 2 Glioma; Recurrent WHO Grade 3 Glioma; Recurrent WHO Grade 4 Glioma
    InterventionBiospecimen Collection; Erdafitinib; Magnetic Resonance Imaging; Optical Coherence Tomography
    PhasePhase 2
    Registry statusActive not recruiting
  • Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial

    NCT05564416 · start 2023-10-12

    Registered record
    Registry ID
    NCT05564416
    Conditions
    Bladder Carcinoma; Bladder Urothelial Carcinoma; Muscle Invasive Bladder Carcinoma; Renal Pelvis and Ureter Urothelial Carcinoma; Stage II Bladder Cancer AJCC v8; Stage III Bladder Cancer AJCC v8; Stage IVA Bladder Cancer AJCC v8; Urothelial Carcinoma
    Interventions
    Atezolizumab; Biospecimen Collection; Biospecimen Collection; Computed Tomography; Cystoscopy; Erdafitinib; Magnetic Resonance Imaging
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2023-10-12
    Completion
    2024-01-01
    Enrolment
    0

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

    ConditionBladder Carcinoma; Bladder Urothelial Carcinoma; Muscle Invasive Bladder Carcinoma; Renal Pelvis and Ureter Urothelial Carcinoma +4 more
    InterventionAtezolizumab; Biospecimen Collection; Biospecimen Collection; Computed Tomography +3 more
    PhasePhase 2
    Registry statusWithdrawn
  • Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations

    NCT06511648 · start 2023-03-07

    Registered record
    Registry ID
    NCT06511648
    Conditions
    Muscle-invasive Bladder Cancer
    Interventions
    Erdafitinib monotherapy; Cetrelimab and Erdafitinib combination
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-03-07
    Completion
    2029-10
    Enrolment
    90

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

    ConditionMuscle-invasive Bladder Cancer
    InterventionErdafitinib monotherapy; Cetrelimab and Erdafitinib combination
    PhasePhase 2
    Registry statusRecruiting
  • A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

    NCT05567185 · start 2023-03-03

    Registered record
    Registry ID
    NCT05567185
    Conditions
    Urinary Bladder Neoplasms; Receptors, Fibroblast Growth Factor
    Interventions
    Erdafitinib Intravesical Delivery System
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2023-03-03
    Completion
    2026-08-30
    Enrolment
    5

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

    ConditionUrinary Bladder Neoplasms; Receptors, Fibroblast Growth Factor
    InterventionErdafitinib Intravesical Delivery System
    PhasePhase 1
    Registry statusActive not recruiting
  • Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

    NCT04963153 · start 2022-07-07

    Registered record
    Registry ID
    NCT04963153
    Conditions
    Locally Advanced Bladder Urothelial Carcinoma; Locally Advanced Renal Pelvis Urothelial Carcinoma; Locally Advanced Ureter Urothelial Carcinoma; Locally Advanced Urethral Urothelial Carcinoma; Locally Advanced Urothelial Carcinoma; Metastatic Bladder Urothelial Carcinoma; Metastatic Renal Pelvis Urothelial Carcinoma; Metastatic Ureter Urothelial Carcinoma; Metastatic Urethral Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Recurrent Bladder Urothelial Carcinoma; Recurrent Renal Pelvis Urothelial Carcinoma; Recurrent Ureter Urothelial Carcinoma; Recurrent Urethral Urothelial Carcinoma; Recurrent Urothelial Carcinoma; Stage IIIB Bladder Cancer AJCC v8; Stage IV Bladder Cancer AJCC v8; Stage IV Renal Pelvis Cancer AJCC v8; Stage IV Ureter Cancer AJCC v8; Stage IV Urethral Cancer AJCC v8
    Interventions
    Biospecimen Collection; Bone Scan; Computed Tomography; Echocardiography Test; Enfortumab Vedotin; Erdafitinib; Multigated Acquisition Scan
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2022-07-07
    Completion
    2026-12-01
    Enrolment
    24

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

    ConditionLocally Advanced Bladder Urothelial Carcinoma; Locally Advanced Renal Pelvis Urothelial Carcinoma; Locally Advanced Ureter Urothelial Carcinoma; Locally Advanced Urethral Urothelial Carcinoma +16 more
    InterventionBiospecimen Collection; Bone Scan; Computed Tomography; Echocardiography Test +3 more
    PhasePhase 1
    Registry statusActive not recruiting
  • Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

    NCT06328491 · start 2022-05-30

    Registered record
    Registry ID
    NCT06328491
    Conditions
    Ovarian Cancer; Steroid Cell Tumor, Malignant
    Interventions
    Erdafitinib
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2022-05-30
    Completion
    2022-08-22
    Enrolment
    1

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

    ConditionOvarian Cancer; Steroid Cell Tumor, Malignant
    InterventionErdafitinib
    PhaseNot applicable
    Registry statusCompleted
  • Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

    NCT05316155 · start 2022-04-11

    Registered record
    Registry ID
    NCT05316155
    Conditions
    Non-Muscle Invasive Bladder Neoplasms
    Interventions
    Erdafitinib Intravesical Delivery System
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Active not recruiting
    Start
    2022-04-11
    Completion
    2029-07-24
    Enrolment
    235

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

    ConditionNon-Muscle Invasive Bladder Neoplasms
    InterventionErdafitinib Intravesical Delivery System
    PhasePhase 1 / Phase 2
    Registry statusActive not recruiting
  • A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

    NCT04917809 · start 2022-02-17

    Registered record
    Registry ID
    NCT04917809
    Conditions
    Bladder Cancer; Recurrent Bladder Cancer; FGFR3 Gene Mutation
    Interventions
    Erdafitinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-02-17
    Completion
    2027-08
    Enrolment
    20

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

    ConditionBladder Cancer; Recurrent Bladder Cancer; FGFR3 Gene Mutation
    InterventionErdafitinib
    PhasePhase 2
    Registry statusActive not recruiting
  • Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib

    NCT05052372 · start 2021-11-21

    Registered record
    Registry ID
    NCT05052372
    Conditions
    Bladder Cancer; Urothelial Carcinoma; Transitional Cell Carcinoma; Platinum-Resistant Urothelial Carcinoma; Bladder Urothelial Carcinoma; FGFR Mutation; FGFR2 Gene Mutation; FGFR3 Gene Mutation; FGFR2 Amplification; Locally Advanced Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Refractory Bladder Carcinoma; Refractory Bladder Urothelial Carcinoma
    Interventions
    Balversa
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Terminated
    Start
    2021-11-21
    Completion
    2022-12-20
    Enrolment
    2

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

    ConditionBladder Cancer; Urothelial Carcinoma; Transitional Cell Carcinoma; Platinum-Resistant Urothelial Carcinoma +9 more
    InterventionBalversa
    PhaseNot recorded
    Registry statusTerminated
  • Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer

    NCT04754425 · start 2021-07-15

    Registered record
    Registry ID
    NCT04754425
    Conditions
    Castration-Resistant Prostate Carcinoma; Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Adenocarcinoma; Metastatic Prostate Small Cell Neuroendocrine Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
    Interventions
    Biopsy; Biospecimen Collection; Erdafitinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-07-15
    Completion
    2026-02-02
    Enrolment
    11

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

    ConditionCastration-Resistant Prostate Carcinoma; Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Adenocarcinoma +4 more
    InterventionBiopsy; Biospecimen Collection; Erdafitinib
    PhasePhase 2
    Registry statusTerminated
  • A Study to Compare the Results of FGFR Testing by Either ctDNA Blood Testing or Standard Tumor Tissue Testing

    NCT06129084 · start 2021-01-11

    Registered record
    Registry ID
    NCT06129084
    Conditions
    Metastatic Bladder Cancer; Metastatic Urothelial Carcinoma
    Interventions
    FGFR Testing
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Active not recruiting
    Start
    2021-01-11
    Completion
    2026-12-31
    Enrolment
    260

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

    ConditionMetastatic Bladder Cancer; Metastatic Urothelial Carcinoma
    InterventionFGFR Testing
    PhaseNot recorded
    Registry statusActive not recruiting