Product Description
Erdafitinib, a tyrosine kinase inhibitor of FGFR1–4, has shown antitumor activity in preclinical models and in a phase 1 study involving patients with FGFR alterations. (Sourced from: https://www.nejm.org/doi/full/10.1056/nejmoa1817323)
Mechanisms of Action: FGFR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Bangladesh | Brazil | Canada | Chile | Egypt | Hong Kong | Israel | Jordan | Korea | Mexico | Peru | Philippines | Saudi Arabia | Singapore | Taiwan | Turkey | United States
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Russia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 23
Highest Development Phases
Phase 3: Bladder Cancer|Muscle Cancer|Transitional Cell Carcinoma
Phase 2: Abnormalities, Multiple|Bile Duct Cancer|Cholangiocarcinoma|Esophageal Cancer|Gastrointestinal Cancer|Hodgkin Lymphoma|Liver Cancer|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Vision, Low
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SOGUG-NEOWIN TRIAL | P2 |
Active, not recruiting |
Bladder Cancer|Muscle Cancer |
2029-02-01 |
|
| 42756493BLC3004 | P3 |
Unknown Status |
Muscle Cancer|Bladder Cancer |
2028-06-28 |
|
| CR109115 | P2 |
Recruiting |
Bladder Cancer|Liver Cancer|Muscle Cancer |
2028-03-30 |
|
| DRUP | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Multiple Myeloma|Vision, Low|Abnormalities, Multiple|Hodgkin Lymphoma |
2027-09-01 |