Multiple Phase 1 through Phase 3 clinical trials evaluate the safety, efficacy, and pharmacokinetics of erdafitinib in urothelial carcinoma, FGFR-altered solid tumors, pediatric malignancies, and bladder cancer, incorporating Phase 2 basket studies and novel intravesical delivery systems like TAR-210. Spanning active, recruiting, completed, and terminated statuses, these clinical trials are sponsored by pharmaceutical entities such as Janssen Research & Development alongside academic institutions and cooperative groups including the National Cancer Institute.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06204614 | ENROLLING_BY_INVITATION | Muscle Invasive Bladder Urothelial Carcinoma |
Brigham and Women's Hospital |
2024-06-14 | EARLY_PHASE1 |
| NCT06319820 | RECRUITING | Non-Muscle Invasive Bladder Neoplasms |
Janssen Research & Development, LLC |
2024-04-18 | PHASE3 |
| NCT06919965 | RECRUITING | Non-Muscle Invasive Bladder Neoplasms |
Janssen Research & Development, LLC |
2025-09-10 | PHASE3 |
| NCT05316155 | ACTIVE_NOT_RECRUITING | Non-Muscle Invasive Bladder Neoplasms |
Janssen Research & Development, LLC |
2022-04-11 | PHASE1; PHASE2 |
| NCT02925234 | RECRUITING | Cancer; Tumors; Neoplasm; Neoplasia |
The Netherlands Cancer Institute |
2016-08 | PHASE2 |
| NCT04917809 | ACTIVE_NOT_RECRUITING | Bladder Cancer; Recurrent Bladder Cancer; FGFR3 Gene Mutation |
Memorial Sloan Kettering Cancer Center |
2022-02-17 | PHASE2 |
| NCT02465060 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma |
National Cancer Institute (NCI) |
2015-08-17 | PHASE2 |
| NCT04963153 | ACTIVE_NOT_RECRUITING | 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 |
National Cancer Institute (NCI) |
2022-07-07 | PHASE1 |
| NCT05859334 | ACTIVE_NOT_RECRUITING | Recurrent Glioma; Recurrent WHO Grade 2 Glioma; Recurrent WHO Grade 3 Glioma; Recurrent WHO Grade 4 Glioma |
National Cancer Institute (NCI) |
2024-01-04 | PHASE2 |
| NCT06511648 | RECRUITING | Muscle-invasive Bladder Cancer |
Spanish Oncology Genito-Urinary Group |
2023-03-07 | PHASE2 |
| NCT04754425 | TERMINATED | 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 |
M.D. Anderson Cancer Center |
2021-07-15 | PHASE2 |
| NCT03155620 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor |
National Cancer Institute (NCI) |
2017-07-31 | PHASE2 |
| NCT05567185 | ACTIVE_NOT_RECRUITING | Urinary Bladder Neoplasms; Receptors, Fibroblast Growth Factor |
Janssen Pharmaceutical K.K. |
2023-03-03 | PHASE1 |
| NCT03732703 | COMPLETED | Relapsed Refractory Multiple Myeloma |
Multiple Myeloma Research Consortium |
2019-04-01 | PHASE1; PHASE2 |
| NCT04172675 | COMPLETED | Urinary Bladder Neoplasms |
Janssen Research & Development, LLC |
2020-02-28 | PHASE2 |
| NCT03390504 | ACTIVE_NOT_RECRUITING | Urothelial Cancer |
Janssen Research & Development, LLC |
2018-03-23 | PHASE3 |
| NCT05564416 | WITHDRAWN | 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 |
National Cancer Institute (NCI) |
2023-10-12 | PHASE2 |
| NCT04083976 | COMPLETED | Advanced Solid Tumor |
Janssen Research & Development, LLC |
2019-11-20 | PHASE2 |
| NCT03210714 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Recurrent Childhood Ependymoma; Recurrent Childhood Malignant Germ Cell Tumor; Recurrent Childhood Medulloblastoma; Recurrent Childhood Non-Hodgkin Lymphoma; Recurrent Childhood Osteosarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Glioma; Recurrent Malignant Solid Neoplasm; Recurrent Neuroblastoma; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Refractory Childhood Malignant Germ Cell Tumor; Refractory Childhood Osteosarcoma; Refractory Childhood Rhabdomyosarcoma; Refractory Childhood Soft Tissue Sarcoma; Refractory Ependymoma; Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Glioma; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Wilms Tumor |
National Cancer Institute (NCI) |
2018-06-05 | PHASE2 |
| NCT05567185 | Recruiting | Urinary Bladder Neoplasms|Receptors Fibroblast Growth Factor |
Janssen Pharmaceutical K.K. |
2023-03-03 | Phase 1 |
| NCT03827850 | TERMINATED | Lung Cancer; NSCLC; Pulmonary Neoplasm; Squamous Cell Lung Cancer; NSCLC Stage IV |
Lung Cancer Group Cologne |
2019-03-25 | PHASE2 |
| NCT03473743 | ACTIVE_NOT_RECRUITING | Urothelial Carcinoma |
Janssen Research & Development, LLC |
2018-04-05 | PHASE1; PHASE2 |
| NCT02365597 | ACTIVE_NOT_RECRUITING | Urothelial Cancer |
Janssen Research & Development, LLC |
2015-04-22 | PHASE2 |
| NCT06328491 | COMPLETED | Ovarian Cancer; Steroid Cell Tumor, Malignant |
University Health Network, Toronto |
2022-05-30 | |
| NCT06308822 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma |
National Cancer Institute (NCI) |
2018-08-20 | PHASE2 |
| NCT03547037 | COMPLETED | Neoplasm |
Janssen Pharmaceutical K.K. |
2018-08-31 | PHASE1 |
| NCT04330248 | COMPLETED | Healthy |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2020-03-31 | PHASE1 |
| NCT06351371 | ACTIVE_NOT_RECRUITING | Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2018-07-03 | PHASE2 |
| NCT05316155 | Recruiting | Urinary Bladder Neoplasms|Receptors Fibroblast Growth Factor |
Janssen Research & Development LLC |
2022-04-11 | Phase 1 |
| NCT05052372 | Terminated | 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 |
xCures |
2021-11-21 | -- |
| NCT02699606 | COMPLETED | Neoplasm |
Janssen Research & Development, LLC |
2016-07-08 | PHASE2 |
| NCT03999515 | TERMINATED | Castration-Resistant Prostate Carcinoma; Double-Negative Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
University of Washington |
2020-04-27 | PHASE2 |
| NCT03238196 | COMPLETED | Metastatic Breast Cancer |
Vanderbilt-Ingram Cancer Center |
2017-08-18 | PHASE1 |
| NCT03587363 | TERMINATED | Hepatic Impairment |
Janssen Research & Development, LLC |
2018-12-06 | PHASE1 |
| NCT04330248 | Completed | Healthy |
Johnson & Johnson Pharmaceutical Research & Development L.L.C. |
2020-03-31 | Phase 1 |
| NCT04083976 | Active not recruiting | Advanced Solid Tumor |
Janssen Research & Development LLC |
2019-11-20 | Phase 2 |
| NCT02421185 | COMPLETED | Carcinoma, Hepatocellular |
Janssen Research & Development, LLC |
2015-05-25 | PHASE1; PHASE2 |
| NCT03135106 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2017-04-14 | PHASE1 |
| NCT03066687 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2017-03-14 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-18)
Check the
Erdafitinib (JNJ-42756493)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Erdafitinib (JNJ-42756493) Solubility in DMSO
- Erdafitinib (JNJ-42756493) Stock Solution
- Erdafitinib (JNJ-42756493) Storage
- Erdafitinib (JNJ-42756493) Stability
- Erdafitinib (JNJ-42756493) Molecular Weight
- Erdafitinib (JNJ-42756493) SMILES
- Erdafitinib (JNJ-42756493) CAS Number
- Erdafitinib (JNJ-42756493) Chemical Structure (2D and 3D)
- Erdafitinib (JNJ-42756493) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.