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: Transitional Cell Carcinoma | Oncology Unspecified
Known Adverse Events: Abdominal Pain | Dysgeusia | Labor Pain | Pain Unspecified | Alopecia | Onycholysis | Mouth Abnormalities | Stomatitis | Musculoskeletal Pain | Skin Abnormalities | Hyperphosphatemia | Keratoconjunctivitis Sicca | Dry Eye Syndromes | Contraception | Pregnancy Outcomes | Pregnancy, Abdominal | Constipation | Diarrhea
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: 26
Highest Development Phases
Phase 3: Bladder Cancer|Muscle Cancer|Transitional Cell Carcinoma
Phase 2: Abnormalities, Multiple|Anal Cancer|Bile Duct Cancer|Cholangiocarcinoma|Esophageal Cancer|Gastrointestinal Cancer|Hodgkin Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Vision, Low
Phase 1: Healthy Volunteers|Liver Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SOGUG-NEOWIN TRIAL | P2 |
Active, not recruiting |
Muscle Cancer|Bladder Cancer |
2029-02-01 |
|
| 42756493BLC3004 | P3 |
Unknown Status |
Muscle Cancer|Bladder Cancer |
2028-06-28 |
|
| CR109115 | P1 |
Recruiting |
Muscle Cancer|Bladder Cancer|Liver Cancer |
2028-03-30 |
|
| DRUP | P2 |
Recruiting |
Abnormalities, Multiple|Anal Cancer|Multiple Myeloma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Hodgkin Lymphoma|Vision, Low |
2027-09-01 |